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This project is responsive to Rehabilitation Research and Development's (RR&D) current special areas of interest for non-pharmacological activity-based interventions for chronic pain impacting pain reduction, function and quality of life. This project aligns with the VA mandate for complementary and integrative health (CIH) care for Veterans and their families. CIH complements traditional care for Veterans managing chronic conditions, such as chronic pain and PTSD. Mission Reconnect (MR) is a user-driven, dyadic, CIH self-care management program delivered remotely that teaches techniques the Veteran/partner dyad can use to reduce pain, anxiety and stress, promote well-being and improve relationship quality. The research goal is to evaluate MR as an approach to manage chronic pain and PTSD symptoms, for potential subsequent implementation. This study will possibly provide a model for establishing remote access and sustainable implementation of CIH within VA.
Chronic pain is one of the most prevalent medical conditions in the Veteran population. Pain often presents with comorbid conditions, specifically post-traumatic stress disorder (PTSD). Comorbid chronic pain and PTSD significantly impact the quality of life of Veterans and their families. Multi-faceted therapies leveraging complementary and integrative health (CIH) are mandated within VA to complement clinical practice guidelines improve Veterans' quality of life and ability to function. This research will evaluate a CIH intervention to manage pain and PTSD related outcomes within a bio-psychosocial framework. The proposed intervention, Mission Reconnect (MR), a user-driven, dyadic, self-care management program delivered online and by mobile app that has previously shown to be effective in a non-clinically defined community-based Veteran/military population. This research is needed to test MR's effects in a clinically defined population as a complement to clinical services to assess for potential subsequent implementation within the Department of Veterans Affairs (VA).
This proposal resubmission is responsive to Veterans' reported desire for CIH and several VA initiatives, including RR&D's current special areas of interest for non-pharmacological activity-based interventions for chronic pain impacting pain reduction, function and quality of life. The VA Secretary of Health Strategic Priorities and the emerging VA Whole Health Program identify access to CIH for pain and self-care management as a priority to achieve optimal Veteran health. To be responsive to these priorities the 2016 VA State-of-the-Art Conference (SOTA) and Comprehensive Addiction Recovery Act (CARA) mandated VA's commitment to conduct rigorous research to integrate non-pharmacological and CIH approaches into care, with emphasis on pain management. This proposal is also responsive to the VA's Opioid Safety Initiative (OSI) and Pain Care Mission which prioritize the need for nonpharmacological treatment options for pain. The short-term goal of this study is to determine the effects of MR on (1) chronic pain, PTSD and related outcomes and (2) relationship outcomes for Veterans and their partners. The long-term goal is to determine the effectiveness and sustainability of using CIH self-care management programs like MR to improve outcomes for Veterans with chronic pain and PTSD, and their partners. The investigators propose a four-year mixed-methods randomized controlled trial of MR with two arms (treatment & wait-list control) in a clinical sample of Veterans with comorbid pain and PTSD, and their partners (e.g., spouse). The specific aims are to: (Aim 1) Determine MR effectiveness for physical (pain, sleep), PTSD (intrusion, arousal, avoidance, numbing), and psychological (depression, stress, anxiety) symptoms, and global health (quality of life); (Aim 2) Determine MR effectiveness for social (relationship satisfaction, compassion for self/others) outcomes among Veterans and their partners; and (Aim 3) Describe Veteran and partner perceived value of MR in a sub-sample of participants. The sample will consist of Veteran and partner dyads (N = 336) at the Ann Arbor, Puget Sound, and Tampa VA facilities. Aim 1 & 2 data collection will include self-report assessment of 4-data points over a 4-month period to evaluate physical, psychological, and social outcomes. Eight weekly reports will also be collected for the first two months of MR use to assess MR utilization, and pain and stress levels. Aim 3 data collection will include telephone interviews from a randomly selected sub-sample of MR treatment group dyads (n = 42) to examine MR user experiences and their suggestions making MR useful for Veterans and their partners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm - Veteran | Active Comparator | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with National Institute of Mental Health (NIMH) funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. |
|
| Control arm - Veteran | No Intervention | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. | |
| Treatment arm - Partner | Experimental | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mission Reconnect | Behavioral | This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Outcomes Questionnaire (POQ) | 20-item questionnaire, used to assess pain, and pain-related subdomains, such as pain intensity, interference with activities, mobility, negative affect, vitality, and pain-related fear. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190 | Baseline, month 1,2,4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, Stress and Tension Likert | Three items will assess pain, stress and tension using a 0 to 5-point Likert-type scale. Higher Scores associated with more adverse patient reported outcomes. Pain Range: 0 - 5 Stress Range: 0 - 5 Tension Range: 0 - 5 | Baseline, Week 1 - 8, Week 16 |
| Defense and Veterans Pain Rating Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Depression: Beck Depression Inventory (BDI) | 21-items, a widely used instrument for measuring depression. Respondents are asked to rate their symptoms and attitudes using a 4-point scale. Beck Depression Inventory (BDI) scores range from 0 to 63 with higher scores indicating more likely depression diagnosis, and higher prevalence of depression symptoms. | Baseline, month 1,2,4 |
Inclusion Criteria:
English-speaking Veterans with chronic musculoskeletal pain.
Veteran is considered to have chronic musculoskeletal pain if he or she meeting either of two validated criteria:
For pain scores, the investigators will use the 0-10 numeric pain rating scale that is routinely collected at the VA.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jolie N. Haun, PhD MS BS | James A. Haley Veterans' Hospital, Tampa, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States | ||
| VA Ann Arbor Healthcare System, Ann Arbor, MI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24959325 | Background | Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Diamond DM, Girling SA, Sullivan KL, Wittenberg T, Witt AM, Lengacher CA, Anderson B, McMillan SC. Accelerated Resolution Therapy for treatment of pain secondary to symptoms of combat-related posttraumatic stress disorder. Eur J Psychotraumatol. 2014 May 7;5. doi: 10.3402/ejpt.v5.24066. eCollection 2014. | |
| 27023420 |
| Label | URL |
|---|---|
| ATLAS.ti: The Qualitative Data Analysis Software | View source |
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Dissemination efforts will be led by Drs. Haun, French, and Fowler, in cooperation with VA operational [e.g. Office of Patient Centered Care and Cultural Transformation (OPCCCT) and Office of Connected Care (OCC)], and clinical stakeholders (e.g. mental health and pain clinicians). The investigators will publish findings in peer-reviewed journals and present findings at national and international meetings including Medicine 2.0, the international conference for internet-based health research (Haun) and Association of Military Surgeons of the United States (AMSUS) Annual Continuing Education Meeting. Dissemination activities will inform Veterans Health Administration (VHA) operational initiatives and clinical practice. The deployment of Whole Health models of care nationally will provide a natural setting for dissemination. The Tampa VEC will support dissemination efforts to Veterans, their families, and to Veteran Service Organizations.
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Instruments may be administered to different individuals at different timepoints. We consented 196 Veterans (Vs) to the Treatment arm (Tx) & 168 Vs to the Waitlist-control arm (WC). Some Partners (Ps) withdrew & new Ps were added to the study. We consented 198 Ps to Tx, & 168 Ps to WC. We have Baseline data for 141 Vs (Tx), 136 Vs (WC), 137 Ps (Tx), & 133 Ps (WC). Satisfaction/utilization were only obtained after Tx initiation. The n's are the number of individuals activated (133 Vs, 133 Ps).
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm - Veteran | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with National Institute of Mental Health (NIMH) funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| FG001 | Treatment Arm - Partner | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| FG002 | Control Arm - Veteran | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| FG003 | Control Arm - Partner | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data was collected from anyone who completed Baseline data collection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm - Veteran | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was calculated at the time of when the participant was activated in the protocol (defined as when both the Veteran and the Partner completed all on-boarding activities). Participants where only one member completed data collection and on-boarding activities did not have an age calculated for them (n = 141 for the Treatment Arm, n = 136 for the Waitlist Control Arm). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Outcomes Questionnaire (POQ) | 20-item questionnaire, used to assess pain, and pain-related subdomains, such as pain intensity, interference with activities, mobility, negative affect, vitality, and pain-related fear. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190 | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans activated in the protocol. Participants that opted out of responding were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, month 1,2,4 |
|
Baseline (before the start of the study activities) and 1, 2 & 4 months after study activities)
While all participants are given a baseline coverage of resources to deal with suicidal ideation, domestic violence issues, and/or severe depression/mental health issues, the Veteran participants are also directly asked at Baseline and at the monthly time points if they specifically have suicidal ideation. An affirmative response of any suicidal ideation with intent and/or plan of action.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm - Veteran | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Ideation | Social circumstances | Suicidal Ideation | Systematic Assessment | Participants reported suicide ideation as part of Patient Reported Outcomes. All Suicide Ideation was escalated to the Veteran's Mental Health provider as per protocol and VA policies. |
Demographics were calculated from study dyads who were successfully activated in the study. Successful activation required both Veteran and Partner of a dyad to complete all Baseline measures. Certain dyads consisted of individuals where one partner completed Baseline data collection before either withdrawing or being Lost to Follow Up (unrelated to study activities). Their data, as per study protocol, were still included in the data models, but were not included in Demographic summaries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jolie Haun | James A. Haley Veteran Hospital Research Service | 904-377-6796 | Jolie.Haun@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 13, 2023 | Oct 4, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
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This research study will evaluate a CIH intervention to manage pain and PTSD related outcomes within a bio-psychosocial framework. The proposed intervention, Mission Reconnect (MR), a user-driven, dyadic, self-care management program delivered online and by mobile app that has previously shown to be effective in a non-clinically defined community-based Veteran/military population.
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There are no masked roles
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|
| Control arm - Partner | No Intervention | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. |
|
10-point scale to measure current pain intensity (past 24 hours) and pain interference (past 24 hours) with activity, sleep, mood, and stress. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Pain Interference with Activity Range: 0 - 10 Pain Interference with Sleep Range: 0 - 10 Pain Interference with Mood Range: 0 - 10 Pain Interference with Stress Range: 0 - 10 |
| Baseline, month 1,2,4 |
| PTSD: Posttraumatic Checklist | 20-item measure of PTSD symptoms Higher Scores associated with more adverse PTSD-related patient reported outcomes. Posttraumatic Stress Disorder Checklist (PCL-5) Range: 0 - 80 | Baseline, month 1,2,4 |
| Quality of Life Short-form (SF12) | 12-items to assess quality of life using physical status and mental health distress. Scores for the Mental Health and Physical Health domains range from 0 to 100, with higher scores indicating better physical and mental health functioning | Baseline, month 1,2,4 |
| Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | 19 self-rated questions from which 7 component scores are calculated and summed into a global score to assess sleep quality in the past month. Each of the domain scores range from 0 (no difficulty) to 3 (severe difficulty). The global score ranges from 0 to 21. Higher scores indicate worse sleep quality. | Baseline, month 1,2,4 |
| Compassion for Self and Others Scales | 26- item (CSS) and 21- item (COS) measures, that calculate an overall Compassion for Others score, an overall Compassion for Self score, and Compassion for Self subscale scores in the domains of Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Overidentification. CSS subdomain scales and the total score (average of components) range from 0 - 5, with higher scores indicating higher self-compassion. COS score ranges from 0 - 7, with higher scores indicating higher compassion for others. | Baseline, month 1,2,4 |
| Stress: Perceived Stress Scale (PSS) | 10 Likert-scaled items, validated and widely used, to determine perceived stress levels. Perceived Stress Scale (PSS) scaled from 0 to 40 with higher scores indicating higher perceived stress. | Baseline, month 1,2,4 |
| Revised Dyadic Adjustment Scale (RDAS) | 14-item Likert-scaled instrument that contains domains for dyadic Consensus (sub-domain Decision Making, Values, and Affection), dyadic Satisfaction (sub-domain Stability and Conflict), and dyadic Cohesion (sub-domain Activities and Discussion). Scores on the Revised Dyadic Adjustment Scale (RDAS) range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress. | Baseline, month 1,2,4 |
| MR Program Satisfaction Items | 11 eleven-point Likert-type items (i.e., 0-10) assess satisfaction using MR components, whether they would recommend MR, and massage satisfaction. Higher scores refer to higher satisfaction with MR. | Month 4 |
| MR Program Utilization | Treatment group: weekly report 11-items will assess frequency of use and compliance of the MR mind/body & massage practices. Measure calculated in number of minutes per week the participant performed the activity. | Month 4 |
| Ann Arbor |
| Michigan |
| 48105 |
| United States |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
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| 23015576 | Background | Nash WP, Watson PJ. Review of VA/DOD Clinical Practice Guideline on management of acute stress and interventions to prevent posttraumatic stress disorder. J Rehabil Res Dev. 2012;49(5):637-48. doi: 10.1682/jrrd.2011.10.0194. |
| 25397827 | Background | Elwy AR, Johnston JM, Bormann JE, Hull A, Taylor SL. A systematic scoping review of complementary and alternative medicine mind and body practices to improve the health of veterans and military personnel. Med Care. 2014 Dec;52(12 Suppl 5):S70-82. doi: 10.1097/MLR.0000000000000228. |
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| 23904323 | Background | Tian TY, Zlateva I, Anderson DR. Using electronic health records data to identify patients with chronic pain in a primary care setting. J Am Med Inform Assoc. 2013 Dec;20(e2):e275-80. doi: 10.1136/amiajnl-2013-001856. Epub 2013 Jul 31. |
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| 22206345 | Background | Ritenbaugh C, Nichter M, Nichter MA, Kelly KL, Sims CM, Bell IR, Castaneda HM, Elder CR, Koithan MS, Sutherland EG, Verhoef MJ, Warber SL, Coons SJ. Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format. BMC Complement Altern Med. 2011 Dec 29;11:135. doi: 10.1186/1472-6882-11-135. |
| 22206409 | Background | Thompson JJ, Kelly KL, Ritenbaugh C, Hopkins AL, Sims CM, Coons SJ. Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: refining content validity through cognitive interviews. BMC Complement Altern Med. 2011 Dec 29;11:136. doi: 10.1186/1472-6882-11-136. |
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| 22588759 | Background | Busija L, Pausenberger E, Haines TP, Haymes S, Buchbinder R, Osborne RH. Adult measures of general health and health-related quality of life: Medical Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of Well-Being Scale (QWB), and Assessment of Quality of Life (AQoL). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S383-412. doi: 10.1002/acr.20541. No abstract available. |
| 27272528 | Background | Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Kwon KN, Morales C, Buckenmaier C' 3rd. Psychometric Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for Military Population. Pain Med. 2016 Aug;17(8):1505-19. doi: 10.1093/pm/pnw105. Epub 2016 Jun 6. |
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| 26653052 | Background | Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14. |
| 8991972 | Background | Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13. |
| 6668417 | Background | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| 2748771 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
| 20717484 | Background | Ten Have TR, Normand SL, Marcus SM, Brown CH, Lavori P, Duan N. Intent-to-Treat vs. Non-Intent-to-Treat Analyses under Treatment Non-Adherence in Mental Health Randomized Trials. Psychiatr Ann. 2008 Dec;38(12):772-783. doi: 10.3928/00485713-20081201-10. No abstract available. |
| 20104399 | Result | Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46(6):697-702. doi: 10.1682/jrrd.2009.01.0006. |
| 39422992 | Derived | Haun JN, Fowler CA, Venkatachalam HH, Alman AC, Ballistrea LM, Schneider T, Benzinger RC, Melillo C, Alexander NB, Klanchar SA, Lapcevic WA, Bair MJ, Taylor SL, Murphy JL, French DD. Outcomes of a Remotely Delivered Complementary and Integrative Health Partnered Intervention to Improve Chronic Pain and Posttraumatic Stress Disorder Symptoms: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 18;26:e57322. doi: 10.2196/57322. |
| 37788078 | Derived | Haun JN, Venkatachalam HH, Fowler CA, Alman AC, Ballistrea LM, Schneider T, Benzinger RC, Melillo C, Alexander NB, Klanchar SA, Lapcevic W, French DD. Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial. J Med Internet Res. 2023 Oct 3;25:e49678. doi: 10.2196/49678. |
| 31094345 | Derived | Haun JN, Ballistrea LM, Melillo C, Standifer M, Kip K, Paykel J, Murphy JL, Fletcher CE, Mitchinson A, Kozak L, Taylor SL, Glynn SM, Bair M. A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial. JMIR Res Protoc. 2019 May 13;8(5):e13666. doi: 10.2196/13666. |
| Statistical Analysis Software, SAS/STAT \| SAS | View source |
| BG001 | Treatment Arm - Partner | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| BG002 | Control Arm - Veteran | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| BG003 | Control Arm - Partner | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| BG004 | Total | Total of all reporting groups |
The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm. |
| Mean |
| Standard Deviation |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Pain Outcomes Questionnaire | Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190. Higher Scores associated with more adverse pain-related patient reported outcomes. | Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm. | Mean | Standard Deviation | units on a scale |
|
| Treatment Arm |
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
| OG001 | Control Arm | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. |
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| Secondary | Pain, Stress and Tension Likert | Three items will assess pain, stress and tension using a 0 to 5-point Likert-type scale. Higher Scores associated with more adverse patient reported outcomes. Pain Range: 0 - 5 Stress Range: 0 - 5 Tension Range: 0 - 5 | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 1 - 8, Week 16 |
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| Secondary | Defense and Veterans Pain Rating Scale | 10-point scale to measure current pain intensity (past 24 hours) and pain interference (past 24 hours) with activity, sleep, mood, and stress. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Pain Interference with Activity Range: 0 - 10 Pain Interference with Sleep Range: 0 - 10 Pain Interference with Mood Range: 0 - 10 Pain Interference with Stress Range: 0 - 10 | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Secondary | PTSD: Posttraumatic Checklist | 20-item measure of PTSD symptoms Higher Scores associated with more adverse PTSD-related patient reported outcomes. Posttraumatic Stress Disorder Checklist (PCL-5) Range: 0 - 80 | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Secondary | Quality of Life Short-form (SF12) | 12-items to assess quality of life using physical status and mental health distress. Scores for the Mental Health and Physical Health domains range from 0 to 100, with higher scores indicating better physical and mental health functioning | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Secondary | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | 19 self-rated questions from which 7 component scores are calculated and summed into a global score to assess sleep quality in the past month. Each of the domain scores range from 0 (no difficulty) to 3 (severe difficulty). The global score ranges from 0 to 21. Higher scores indicate worse sleep quality. | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Secondary | Compassion for Self and Others Scales | 26- item (CSS) and 21- item (COS) measures, that calculate an overall Compassion for Others score, an overall Compassion for Self score, and Compassion for Self subscale scores in the domains of Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Overidentification. CSS subdomain scales and the total score (average of components) range from 0 - 5, with higher scores indicating higher self-compassion. COS score ranges from 0 - 7, with higher scores indicating higher compassion for others. | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Vets and Parts who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Other Pre-specified | Depression: Beck Depression Inventory (BDI) | 21-items, a widely used instrument for measuring depression. Respondents are asked to rate their symptoms and attitudes using a 4-point scale. Beck Depression Inventory (BDI) scores range from 0 to 63 with higher scores indicating more likely depression diagnosis, and higher prevalence of depression symptoms. | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Other Pre-specified | Stress: Perceived Stress Scale (PSS) | 10 Likert-scaled items, validated and widely used, to determine perceived stress levels. Perceived Stress Scale (PSS) scaled from 0 to 40 with higher scores indicating higher perceived stress. | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Other Pre-specified | Revised Dyadic Adjustment Scale (RDAS) | 14-item Likert-scaled instrument that contains domains for dyadic Consensus (sub-domain Decision Making, Values, and Affection), dyadic Satisfaction (sub-domain Stability and Conflict), and dyadic Cohesion (sub-domain Activities and Discussion). Scores on the Revised Dyadic Adjustment Scale (RDAS) range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress. | Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Vets and Parts who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, month 1,2,4 |
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| Other Pre-specified | MR Program Satisfaction Items | 11 eleven-point Likert-type items (i.e., 0-10) assess satisfaction using MR components, whether they would recommend MR, and massage satisfaction. Higher scores refer to higher satisfaction with MR. | Instrument requests experiences with treatment. Instrument only administered to Veterans and Partners in the Treatment Arm who were activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses for the instrument. | Posted | Median | Inter-Quartile Range | units on a scale | Month 4 |
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| Other Pre-specified | MR Program Utilization | Treatment group: weekly report 11-items will assess frequency of use and compliance of the MR mind/body & massage practices. Measure calculated in number of minutes per week the participant performed the activity. | Instrument requests experiences with treatment. Instrument only administered to Veterans and Partners in the Treatment Arm who were activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses for the instrument. | Posted | Median | Inter-Quartile Range | minutes per week | Month 4 |
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| 0 |
| 196 |
| 0 |
| 196 |
| 7 |
| 196 |
| EG001 | Treatment Arm - Partner | Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. | 0 | 198 | 0 | 198 | 0 | 198 |
| EG002 | Control Arm - Veteran | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. | 0 | 168 | 0 | 168 | 7 | 168 |
| EG003 | Control Arm - Partner | Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection. Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. | 0 | 168 | 0 | 168 | 0 | 168 |
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Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Stress (on 5-point Likert Scale) |
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| Tension (on 5-point Likert Scale) |
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| Other |
Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Stress as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1002 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00190 | Standard Error of the Mean | 0.001152 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Tension as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.7311 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000343 | Standard Error of the Mean | 0.000996 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Pain Interference with Sleep |
|
| Pain Interference with Mood |
|
| Pain Interference with Stress |
|
| Other |
Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Pain Interference with Activity as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.2540 | Slope | -0.00235 | Standard Error of the Mean | 0.002052 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Pain Interference with Sleep as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0082 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00612 | Standard Error of the Mean | 0.002297 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Pain Interference with Mood as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0079 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00636 | Standard Error of the Mean | 0.002378 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Pain Interference with Stress as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1588 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00334 | Standard Error of the Mean | 0.002367 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Other |
Treatment is compared against a Waitlist Control Group. |
| Other |
Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Mental Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0277 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.01738 | Standard Error of the Mean | 0.007848 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Pittsburgh Sleep Quality Index - Sleep duration |
|
| Pittsburgh Sleep Quality Index - Sleep efficiency |
|
| Pittsburgh Sleep Quality Index - Sleep disturbance |
|
| Pittsburgh Sleep Quality Index - Use of sleep medication |
|
| Pittsburgh Sleep Quality Index - Daytime dysfunction |
|
| Pittsburgh Sleep Quality Index - Global PSQI Score |
|
| Other |
Treatment is compared against a Waitlist Control Group. |
| Analysis performed on PSQI Subjective Sleep Quality Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.2438 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00092 | Standard Error of the Mean | 0.000790 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on PSQI Sleep latency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.7317 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000304 | Standard Error of the Mean | 0.000885 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on PSQI Sleep duration Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.6393 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00062 | Standard Error of the Mean | 0.001327 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on PSQI Sleep efficiency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1995 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00112 | Standard Error of the Mean | 0.000873 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on PSQI Sleep disturbance Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.2886 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00072 | Standard Error of the Mean | 0.000675 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on PSQI Use of sleep medication Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1323 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.002048 | Standard Error of the Mean | 0.001356 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on PSQI Daytime dysfunction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.7923 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000209 | Standard Error of the Mean | 0.000793 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Overall CSS |
|
| CSS, Self-kindness Subdomain |
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| CSS, Self-judgment Subdomain |
|
| CSS, Common Humanity Subdomain |
|
| CSS, Isolation Subdomain |
|
| CSS, Mindfulness Subdomain |
|
| CSS, Over-identification Subdomain |
|
| Other |
Treatment is compared against a Waitlist Control Group. |
| Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1607 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.001083 | Standard Error of the Mean | 0.000769 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS- Total as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1260 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000984 | Standard Error of the Mean | 0.000640 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.3311 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000909 | Standard Error of the Mean | 0.000933 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.2416 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.001041 | Standard Error of the Mean | 0.000887 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.3903 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00087 | Standard Error of the Mean | 0.001016 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.2131 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.001186 | Standard Error of the Mean | 0.000950 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1130 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.001485 | Standard Error of the Mean | 0.000933 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0358 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.001983 | Standard Error of the Mean | 0.000939 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS- Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.7027 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00019 | Standard Error of the Mean | 0.000495 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.2979 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000761 | Standard Error of the Mean | 0.000730 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.4278 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00063 | Standard Error of the Mean | 0.000798 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.9933 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.0000074 | Standard Error of the Mean | 0.000877 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1589 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00115 | Standard Error of the Mean | 0.000816 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.8875 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000109 | Standard Error of the Mean | 0.000767 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.6859 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00032 | Standard Error of the Mean | 0.000780 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Other |
Treatment is compared against a Waitlist Control Group. |
| Other |
Treatment is compared against a Waitlist Control Group. |
| Subdomain: Decision Making. Consensus Domain, RDAS |
|
| Subdomain: Values. Consensus Domain, RDAS |
|
| Subdomain: Affection. Consensus Domain, RDAS |
|
| Total Consensus Domain, RDAS |
|
| Subdomain: Stability. Satisfaction Domain, RDAS |
|
| Subdomain: Conflict. Satisfaction Domain, RDAS |
|
| Total Satisfaction Domain, RDAS |
|
| Subdomain: Activities. Cohesion Domain, RDAS |
|
| Subdomain: Discussion. Cohesion Domain, RDAS |
|
| Total Cohesion Domain, RDAS |
|
| Other |
Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.3711 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.002105 | Standard Error of the Mean | 0.002349 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.4280 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.001864 | Standard Error of the Mean | 0.002348 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Affection Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.9831 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00007 | Standard Error of the Mean | 0.003205 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.6320 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.003052 | Standard Error of the Mean | 0.006364 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.9755 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000070 | Standard Error of the Mean | 0.002259 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.7584 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000560 | Standard Error of the Mean | 0.001818 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.9313 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000297 | Standard Error of the Mean | 0.003444 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.5401 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00129 | Standard Error of the Mean | 0.002097 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.9421 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.000180 | Standard Error of the Mean | 0.002471 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.7042 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00151 | Standard Error of the Mean | 0.003983 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Total RDAS Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0114 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.02128 | Standard Error of the Mean | 0.008331 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1358 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.002587 | Standard Error of the Mean | 0.001727 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.4354 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.001402 | Standard Error of the Mean | 0.001796 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on AffectionSubdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0070 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.005759 | Standard Error of the Mean | 0.002113 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0217 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.01037 | Standard Error of the Mean | 0.004485 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.7881 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | -0.00039 | Standard Error of the Mean | 0.001461 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0010 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.004717 | Standard Error of the Mean | 0.001410 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.0693 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.004393 | Standard Error of the Mean | 0.002415 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1184 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.002959 | Standard Error of the Mean | 0.001887 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1301 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.003436 | Standard Error of the Mean | 0.002262 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be <0.1. | Mixed Models Analysis | 0.1049 | p value provided is for interaction term between Time (continuous) * Treatment group (MR vs. WC) | Slope | 0.006022 | Standard Error of the Mean | 0.003697 | 2-Sided | Other | Treatment is compared against a Waitlist Control Group. |
| Response to "I am satisfied with the "Connecting to Yourself" activities." |
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| Response to "I am satisfied with my ability to connect with myself." |
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| Response to "I am satisfied with the "Connecting with Quiet" activities." |
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| Response to "I am satisfied with my ability to connect with quiet." |
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| Response to "I am satisfied with the "Connecting with Your Partner" activities." |
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| Response to "I am satisfied with my ability to connect with my partner." |
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| Response to "I am satisfied with receiving massage from my partner." |
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| Response to "I am satisfied with my ability to give my partner massage." |
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| Response to "I am satisfied with the Mission Reconnect Support Materials activities." |
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| Utilization in the "Connecting with your Partner" Domain |
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| Total Utilization |
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