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The goal of this project is to conduct an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline and post-intervention.
This study received support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).
The aim of this phase is to establish feasibility (primary), acceptability, and fidelity of GetActive+ and study procedures in an open pilot (N=30). Deliverables: GetActive+ will be feasible (≥75% agree to participate), acceptable (≥75% of those enrolled will complete 8/10 sessions) and delivered with fidelity (≥75% sessions delivered as intended).
Our patients will be older adults with chronic pain from Revere HealthCare Center.
The GetActive+ program will incorporate mind-body skills, cognitive behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance based and objective (step count) physical function. This program will teach participants four core skills: 1) weekly goal setting for gradual increase in time spent walking paired with activities of daily living that are meaningful and important to participants (i.e. walk instead of drive to the store; walk to the park with kids) 2) quota-based pacing (increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., diaphragmatic breathing to manage intense pain flares and pain anxiety; body scan to increase body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the transience of pain and change one's relationship with it; self-compassion when falling short of set goals); and 4) understand the downward spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or unhelpful pain-related thoughts that interfere with meeting program goals. Participants will be encouraged to complete their homework (logs for mind-body practice, physical activities) each day. Participants will be given the option to receive homework and session reminders via text messages from study staff. This between session contact will focus on increasing treatment adherence, maintaining engagement, and session reminders. The investigators will run groups primarily in English with an additional two groups in Spanish.
Baseline assessments and post-intervention assessments will include the six-minute walk test (6MWT), objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GetActive+ | Experimental | A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GetActive+ | Behavioral | 10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota-based pacing and goal setting, adapted specifically for older adults from a medically underserved location. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention Completion | >=75 of patients approached agree to participate in intervention | 10 weeks |
| Acceptability | >=75% of enrolled participants complete at least 8/10 sessions | 10 weeks |
| Fidelity of Session Components, As Rated by Clinicians | Clinician raters, with experience in intervention refinement or delivery, randomly selected 20% of all sessions to rate their components for this outcome. All sessions were audio-recorded. The overall number of units analyzed, which is reported below, refers to that 20% of the total number of sessions that were then analyzed for this outcome); the overall number of participants analyzed, which is also reported below, is the total number of participants in this study. Clinician raters used fidelity checklists to guide their ratings of the different session components. A session component was considered delivered as intended if the rater provided a score ≥8 (the scale was 1=poor to 10=outstanding). Reported here are the number of session components with a score ≥8, indicating successful delivery; the percentage of the total analyzed sessions that this represents is also calculated out below. The study benchmark we looked to meet for this fidelity measure was 75%. | Fidelity, as described above, was assessed periodically throughout the 11 months of the study, and is presented here as the sum total counts of all the high scoring components (again, described above) that were assessed over this 11 month time period. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function - Performance-based | 6-minute walk test (6MWT), assesses distance walked (in meters) in 6 minutes. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Physical Function - Objective |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Assessment of Intervention by Participants | Qualitative information was collected from patients through one-on-one exit interviews assessing perceptions of intervention; these were completely qualitative (i.e. held through discussions and not by using surveys or structured questions, etc). The reported result is the number of participants who completed this optional exit interview after intervention completion. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33469845 | Background | Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19. | |
| 35914640 | Background |
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| ID | Type | URL | Comment |
|---|---|---|---|
| VIV0001019 | Individual Participant Data Set | View IPD |
Data can be accessed in the Vivli data repository
Data is currently available in the repository.
No specialized tools will be needed to access the data other than what is noted on the Vivli website.
All enrolled participants were assigned to the intervention, GetActive+.
Recruitment was facilitated through posted Massachusetts General Hospital (MGH) Institutional Review Board-approved flyers in the clinic and the hospital's research recruitment site, and referrals from MGH Revere HealthCare Center physicians, nurses, psychologists, and other relevant staff.
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| ID | Title | Description |
|---|---|---|
| FG000 | GetActive+ | 10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota-based pacing and goal setting, adapted specifically for older adults from a medically underserved location. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GetActive+ | 10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota-based pacing and goal setting, adapted specifically for older adults from a medically underserved location. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility of Intervention Completion | >=75 of patients approached agree to participate in intervention | Posted | Count of Participants | Participants | 10 weeks |
|
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Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
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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 | Experimental: GetActive+ | A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney Stones and Infection | General disorders | Non-systematic Assessment | Hospitalization due to kidney stone surgery and consequent infection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain/injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | 617-724-4977 | avranceanu@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2024 | Apr 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2023 | Apr 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Average step count with ActiGraph GT3X-BTLE
| Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales | The Short Form Brief Pain Inventory (BPI) pain severity subscale assesses pain at its worst, least, average, and current. Minimum = 0, maximum = 10. Higher scores indicate worse outcome. The interference subscale assesses pain interference in the last 24 hours. Minimum = 0, maximum = 10. Higher scores indicate worse interference. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Patient Health Questionnaire-8 (PHQ-8) | The Patient Health Questionnaire (PHQ-8) is an assessment of depressive symptoms. Total summary score with Minimum = 0, Maximum = 24. Higher scores indicate worse outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Generalized Anxiety Disorder Scale-7 (GAD-7); | The Generalized Anxiety Disorder scale-7 (GAD-7) is an assessment of generalized anxiety symptoms. GAD-7 total score is obtained by adding the score for each of the items. Minimum = 0, Maximum = 21. Scores of 5-9 (mild), 10-14 (moderate), and 15-21 (severe) represent thresholds for mild, moderate, and severe anxiety. Higher scores indicate worse outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| PROMIS Physical Function - Short Form 6b v2.0 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b assesses one's ability to engage in physical activities. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the average (mean) physical function T score in the reference general population, with a standard deviation of 10. Higher T scores reflect greater physical function and ability to carry out physical activities. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| The Interpersonal Support Evaluation List (ISEL-12), | The Interpersonal Support Evaluation List (ISEL-12) measures perceptions of social support. Minimum = 12, Maximum = 48. Higher scores indicate a better outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) is a 13-item measure that assesses hopelessness, helplessness and rumination about pain. Subscales (rumination, magnification, and helplessness) are calculated by summing item responses for the associated questions, and then combined (summed) to create the total score. Items range from 0-4, and total scores range from 0-52. For the subscales, rumination ranges from 0-16, magnification ranges from 0-12, and helplessness ranges from 0-24. Higher scores (on subscales and the scale as a whole) indicate higher levels of pain catastrophizing, i.e. higher scores indicate poorer outcomes. Both subscales and total score are shown here. The means reported reflect the mean of each subscale or total score among GetActive+ participants at the indicated timepoint. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Pain, Enjoyment of Life and General Activity Scale (PEG) | The Pain, Enjoyment of Life and General Activity scale (PEG) rates a participant's pain intensity and related interference in enjoyment of life and general activity. Items are scored on a scale of 0-10, with 0 being no pain (or interference) and 10 being pain as bad as you can imagine (or complete interference). The total score is a sum of the three individual items (Pain Intensity Average, Activity Interference, Enjoyment Interference) divided by 3, with a minimum possible score of 0 and a maximum possible score of 10. Higher scores indicate worse outcomes (i.e. more pain intensity and interference). Scores presented here are the mean total score and mean item scores at the indicated timepoints. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Applied Mindfulness Process Scale (AMPS) | The Applied Mindfulness Process Scale (AMPS) assesses how participants use mindfulness when facing challenges in daily life. Sum all 15 items to obtain a total score ranging from 0-60. Higher scores indicate higher utilization of mindfulness | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) | Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) rates a participant's broad conceptualization of mindfulness,. Minimum = 12 Maximum = 48. Higher values reflect higher levels of mindfulness. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Perceived Stress Scale (PSS-4) | The Perceived Stress Scale (PSS-4) assesses stress perception levels. Total sum of scores. Minimum = 0 Maximum =16; Higher scores are correlated to more stress. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form) | The Post-Traumatic Checklist-Civilian Version-6 (PCL-C short form) assesses current Post Traumatic Stress Disorder symptoms. Items in the measure are scored on a scale of 1-5, with 5 indicating being extremely bothered by a problem (related to stressful experiences) in the past month, and 1 indicating not being bothered at all. The total score is a sum of all item responses; this can range from 6 - 30. Higher scores are suggestive of difficulties with post-traumatic stress, and further assessment and possibly referral for treatment may be indicated especially if a score is 14 or more. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration | The Pittsburgh Sleep Quality Index (PSQI) is a four-question measure assessing sleep quality. This study ONLY utilized question 4 of the measure, which asks about sleep duration in hours and minutes per night (the time spent actually asleep, not just in bed). Reported below as an outcome is the mean hours of sleep reported by participants at baseline and posttest, i.e. the mean hours reported by participants as captured in Question 4 only of the PSQI measure. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| PROMIS Sleep Disturbance - Short Form 6a v1.0 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a v1.0 assesses quality of sleep. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the T score for the average quality of sleep in the reference general population, with a standard deviation of 10. Higher T scores reflect greater sleep disturbance, and thus worse outcomes. The means reported are the mean T scores at the indicated timepoint. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Everyday Discrimination Scale - Short (EDS-S) | The Everyday Discrimination Scale - Short (EDS-S) assesses the frequency of experiences of discrimination. Each item is scored on a scale of 0-5, with 0 indicating never experiencing that situation, and 5 indicating experiencing it almost every day. Responses are then summed across items, with final scores ranging from 0 - 25. Higher scores indicate greater frequency of discriminatory experiences. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS) | The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) assess substance use behaviors. No summary score. Each item is scored individually for each substance. For each item, higher scores indicate better outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Contrast Avoidance Questionnaire - Shortened (CAQ-S) | Contrast Avoidance Questionnaire - Shortened (CAQ-S) a measure of sustaining negative emotionality to protect against sudden shifts in emotion. Minimum = 8, Maximum = 40 with higher scores indicating worse outcomes. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) measures changes in pain in response to treatment. Minimum = 0, Maximum = 6. Higher scores indicate worse outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Tampa Scale for Kinesiophobia-11 (TSK11) | The Tampa Scale for Kinesiophobia-11 (TSK11) is an 11-item questionnaire that assesses fear avoidance and fear of activity. Summary score of total responses with Minimum = 11 and Maximum = 44. Higher scores indicate higher kinesiophobia. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| UCLA-3 Loneliness Scale | The UCLA-3 Loneliness Scale measures isolation / perceived lack of social connectedness. Minimum = 3, Maximum = 9. Higher scores indicate worse outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Measure of Current Status (MOCS) | The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Minimum = 0, maximum = 52. Higher scores indicate better outcome and a stronger ability to recognize stress and cope. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Self-Compassion Scale - Short Form (SCS-SF) | The Self-Compassion Scale - Short Form (SCS-SF) is the rate of a participant's amount of self-compassion. Scores are calculated by averaging the 12 items with Minimum = 1, Maximum = 5. Higher scores indicate worse outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Gratitude Questionnaire (GQ-6) | The Gratitude Questionnaire (GQ-6) assesses the proneness to experience gratitude in daily life. All items individual items are scored from 1=strongly disagree to 7=strongly agree. The total score is a sum of all the items, with a minimum of 6 and maximum of 42. Higher scores indicate a greater amount of gratitude. Results are reported for baseline and posttest (timepoint indicated by the row title description)> | Baseline (0 weeks), Post-test (1 week after intervention completion) |
| Post-test (1 week after intervention completion) |
| Grunberg VA, Greenberg J, Mace RA, Bakhshaie J, Choi KW, Vranceanu AM. Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. J Pain. 2022 Nov;23(11):1933-1944. doi: 10.1016/j.jpain.2022.07.003. Epub 2022 Jul 29. |
| 33971485 | Background | Popok PJ, Greenberg J, Gates MV, Vranceanu AM. A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Complement Ther Clin Pract. 2021 Aug;44:101410. doi: 10.1016/j.ctcp.2021.101410. Epub 2021 May 2. |
| 38157234 | Background | McDermott K, Levey N, Brewer J, Ehmann M, Hooker JE, Pasinski R, Yousif N, Raju V, Gholston M, Greenberg J, Ritchie CS, Vranceanu AM. Improving Health for Older Adults With Pain Through Engagement: Protocol for Tailoring and Open Pilot Testing of a Mind-Body Activity Program Delivered Within Shared Medical Visits in an Underserved Community Clinic. JMIR Res Protoc. 2023 Dec 29;12:e52117. doi: 10.2196/52117. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
|---|
| Participants |
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| Primary | Acceptability | >=75% of enrolled participants complete at least 8/10 sessions | Posted | Count of Participants | Participants | 10 weeks |
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| Primary | Fidelity of Session Components, As Rated by Clinicians | Clinician raters, with experience in intervention refinement or delivery, randomly selected 20% of all sessions to rate their components for this outcome. All sessions were audio-recorded. The overall number of units analyzed, which is reported below, refers to that 20% of the total number of sessions that were then analyzed for this outcome); the overall number of participants analyzed, which is also reported below, is the total number of participants in this study. Clinician raters used fidelity checklists to guide their ratings of the different session components. A session component was considered delivered as intended if the rater provided a score ≥8 (the scale was 1=poor to 10=outstanding). Reported here are the number of session components with a score ≥8, indicating successful delivery; the percentage of the total analyzed sessions that this represents is also calculated out below. The study benchmark we looked to meet for this fidelity measure was 75%. | Posted | Count of Units | Number of session components | Fidelity, as described above, was assessed periodically throughout the 11 months of the study, and is presented here as the sum total counts of all the high scoring components (again, described above) that were assessed over this 11 month time period. | Number of session components | Number of session components |
|
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| Secondary | Physical Function - Performance-based | 6-minute walk test (6MWT), assesses distance walked (in meters) in 6 minutes. | Posted | Mean | Standard Deviation | meters | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Physical Function - Objective | Average step count with ActiGraph GT3X-BTLE | Posted | Mean | Standard Deviation | steps | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales | The Short Form Brief Pain Inventory (BPI) pain severity subscale assesses pain at its worst, least, average, and current. Minimum = 0, maximum = 10. Higher scores indicate worse outcome. The interference subscale assesses pain interference in the last 24 hours. Minimum = 0, maximum = 10. Higher scores indicate worse interference. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
|
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| Secondary | Patient Health Questionnaire-8 (PHQ-8) | The Patient Health Questionnaire (PHQ-8) is an assessment of depressive symptoms. Total summary score with Minimum = 0, Maximum = 24. Higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Generalized Anxiety Disorder Scale-7 (GAD-7); | The Generalized Anxiety Disorder scale-7 (GAD-7) is an assessment of generalized anxiety symptoms. GAD-7 total score is obtained by adding the score for each of the items. Minimum = 0, Maximum = 21. Scores of 5-9 (mild), 10-14 (moderate), and 15-21 (severe) represent thresholds for mild, moderate, and severe anxiety. Higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
|
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|
| Secondary | PROMIS Physical Function - Short Form 6b v2.0 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b assesses one's ability to engage in physical activities. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the average (mean) physical function T score in the reference general population, with a standard deviation of 10. Higher T scores reflect greater physical function and ability to carry out physical activities. | Posted | Mean | Standard Deviation | T score | Baseline (0 weeks), Post-test (1 week after intervention completion) |
|
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| Secondary | The Interpersonal Support Evaluation List (ISEL-12), | The Interpersonal Support Evaluation List (ISEL-12) measures perceptions of social support. Minimum = 12, Maximum = 48. Higher scores indicate a better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) is a 13-item measure that assesses hopelessness, helplessness and rumination about pain. Subscales (rumination, magnification, and helplessness) are calculated by summing item responses for the associated questions, and then combined (summed) to create the total score. Items range from 0-4, and total scores range from 0-52. For the subscales, rumination ranges from 0-16, magnification ranges from 0-12, and helplessness ranges from 0-24. Higher scores (on subscales and the scale as a whole) indicate higher levels of pain catastrophizing, i.e. higher scores indicate poorer outcomes. Both subscales and total score are shown here. The means reported reflect the mean of each subscale or total score among GetActive+ participants at the indicated timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
|
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| Secondary | Pain, Enjoyment of Life and General Activity Scale (PEG) | The Pain, Enjoyment of Life and General Activity scale (PEG) rates a participant's pain intensity and related interference in enjoyment of life and general activity. Items are scored on a scale of 0-10, with 0 being no pain (or interference) and 10 being pain as bad as you can imagine (or complete interference). The total score is a sum of the three individual items (Pain Intensity Average, Activity Interference, Enjoyment Interference) divided by 3, with a minimum possible score of 0 and a maximum possible score of 10. Higher scores indicate worse outcomes (i.e. more pain intensity and interference). Scores presented here are the mean total score and mean item scores at the indicated timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Applied Mindfulness Process Scale (AMPS) | The Applied Mindfulness Process Scale (AMPS) assesses how participants use mindfulness when facing challenges in daily life. Sum all 15 items to obtain a total score ranging from 0-60. Higher scores indicate higher utilization of mindfulness | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) | Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) rates a participant's broad conceptualization of mindfulness,. Minimum = 12 Maximum = 48. Higher values reflect higher levels of mindfulness. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Perceived Stress Scale (PSS-4) | The Perceived Stress Scale (PSS-4) assesses stress perception levels. Total sum of scores. Minimum = 0 Maximum =16; Higher scores are correlated to more stress. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form) | The Post-Traumatic Checklist-Civilian Version-6 (PCL-C short form) assesses current Post Traumatic Stress Disorder symptoms. Items in the measure are scored on a scale of 1-5, with 5 indicating being extremely bothered by a problem (related to stressful experiences) in the past month, and 1 indicating not being bothered at all. The total score is a sum of all item responses; this can range from 6 - 30. Higher scores are suggestive of difficulties with post-traumatic stress, and further assessment and possibly referral for treatment may be indicated especially if a score is 14 or more. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration | The Pittsburgh Sleep Quality Index (PSQI) is a four-question measure assessing sleep quality. This study ONLY utilized question 4 of the measure, which asks about sleep duration in hours and minutes per night (the time spent actually asleep, not just in bed). Reported below as an outcome is the mean hours of sleep reported by participants at baseline and posttest, i.e. the mean hours reported by participants as captured in Question 4 only of the PSQI measure. | 23 participants provided this information at baseline, but only 19 participants provided it at posttest. | Posted | Mean | Standard Deviation | hours | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | PROMIS Sleep Disturbance - Short Form 6a v1.0 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a v1.0 assesses quality of sleep. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the T score for the average quality of sleep in the reference general population, with a standard deviation of 10. Higher T scores reflect greater sleep disturbance, and thus worse outcomes. The means reported are the mean T scores at the indicated timepoint. | Posted | Mean | Standard Deviation | T-score | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Everyday Discrimination Scale - Short (EDS-S) | The Everyday Discrimination Scale - Short (EDS-S) assesses the frequency of experiences of discrimination. Each item is scored on a scale of 0-5, with 0 indicating never experiencing that situation, and 5 indicating experiencing it almost every day. Responses are then summed across items, with final scores ranging from 0 - 25. Higher scores indicate greater frequency of discriminatory experiences. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS) | The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) assess substance use behaviors. No summary score. Each item is scored individually for each substance. For each item, higher scores indicate better outcome. | Posted | Count of Participants | Participants | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Contrast Avoidance Questionnaire - Shortened (CAQ-S) | Contrast Avoidance Questionnaire - Shortened (CAQ-S) a measure of sustaining negative emotionality to protect against sudden shifts in emotion. Minimum = 8, Maximum = 40 with higher scores indicating worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) measures changes in pain in response to treatment. Minimum = 0, Maximum = 6. Higher scores indicate worse outcome. | Posted | Count of Participants | Participants | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Tampa Scale for Kinesiophobia-11 (TSK11) | The Tampa Scale for Kinesiophobia-11 (TSK11) is an 11-item questionnaire that assesses fear avoidance and fear of activity. Summary score of total responses with Minimum = 11 and Maximum = 44. Higher scores indicate higher kinesiophobia. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | UCLA-3 Loneliness Scale | The UCLA-3 Loneliness Scale measures isolation / perceived lack of social connectedness. Minimum = 3, Maximum = 9. Higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Measure of Current Status (MOCS) | The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Minimum = 0, maximum = 52. Higher scores indicate better outcome and a stronger ability to recognize stress and cope. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Self-Compassion Scale - Short Form (SCS-SF) | The Self-Compassion Scale - Short Form (SCS-SF) is the rate of a participant's amount of self-compassion. Scores are calculated by averaging the 12 items with Minimum = 1, Maximum = 5. Higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Secondary | Gratitude Questionnaire (GQ-6) | The Gratitude Questionnaire (GQ-6) assesses the proneness to experience gratitude in daily life. All items individual items are scored from 1=strongly disagree to 7=strongly agree. The total score is a sum of all the items, with a minimum of 6 and maximum of 42. Higher scores indicate a greater amount of gratitude. Results are reported for baseline and posttest (timepoint indicated by the row title description)> | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 weeks), Post-test (1 week after intervention completion) |
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| Other Pre-specified | Qualitative Assessment of Intervention by Participants | Qualitative information was collected from patients through one-on-one exit interviews assessing perceptions of intervention; these were completely qualitative (i.e. held through discussions and not by using surveys or structured questions, etc). The reported result is the number of participants who completed this optional exit interview after intervention completion. | Posted | Count of Participants | Participants | Post-test (1 week after intervention completion) |
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| 0 |
| 33 |
| 3 |
| 33 |
| 17 |
| 33 |
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| Suicide attempt, Command hallucinations for suicide | Psychiatric disorders | Non-systematic Assessment | Report of suicide attempt and hearing near constant thoughts of suicide. |
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| Adverse effect of drug or medicament | Injury, poisoning and procedural complications | Non-systematic Assessment | Hospitalization due to complications from new medication. |
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| Fall on same level from slipping, tripping or stumbling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Severe Nosebleed (Epistaxis) | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Kidney Stones | Renal and urinary disorders | Non-systematic Assessment |
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| Syncopal Episode | Nervous system disorders | Non-systematic Assessment |
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| Fall on or from stairs or steps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Thrombophlebitis | Cardiac disorders | Non-systematic Assessment |
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| Arrhythmias | Cardiac disorders | Non-systematic Assessment | One arrhythmia episode was accompanied by dizziness and temporary hearing loss in right ear. |
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| Fall from furniture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Concern regarding prior hip replacement | Surgical and medical procedures | Non-systematic Assessment |
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Not provided
Not provided
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| Title | Measurements |
|---|---|
|
| Rumination- Post-test |
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| Magnification - Baseline |
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| Magnification - Post-test |
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| Helplessness - Baseline |
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| Helplessness - Post-test |
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| Title | Measurements |
|---|---|
|
| Average Pain Intensity (Posttest) |
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| Activity Interference (Baseline) |
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| Activity Interference (Posttest) |
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| Enjoyment Interference (Baseline) |
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| Enjoyment Interference (Posttest) |
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| Weekly |
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| Daily or almost daily |
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| Prefer not to respond |
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| Binge Drinking |
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| Prescription Drug Use |
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| No change |
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| Minimally worse |
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| Much worse or very much worse |
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