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The aims of this study are to adapt, pilot, and examine the credibility, acceptability, and feasibility of an evidence-based mind-body program, the Relaxation Response Resiliency Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is the p3RP integrated with a commercial DMD, the Fitbit.
The study has three phases. In phase I, the investigators are adapting the 3RP as a multidisciplinary team, and then conducting two focus groups. In phase two, the investigators are piloting the p3RP and p3RP-DMD. In phase three, the investigators are conducting a small randomized-controlled trial of the p3RP versus p3RP-DMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GetActive | Experimental | The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. |
|
| GetActive with Fitbit | Experimental | The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GetActive | Behavioral | GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint | Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. | Post-Test (10 Weeks) |
| Therapist Adherence | Two independent coders rated whether clinicians delivered each component of study sessions (e.g., deep breathing, providing education on prevalent myths about chronic pain) , exhibited skillful delivery (e.g., active listening, validation), and followed study protocol (e.g., collecting home practice sheets, logging attendance). Each individual component was rated on a yes/no scale. The adherent ("yes") components were summed, tallied against the total number of components in the adherence checklist, and averaged between the 2 reviewers. The score represents a total rate of adherence. | Collected during the intervention |
| Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Rate of participant's use of ActiGraph watch for a period of one week at both baseline and post-treatment assessments. A valid day of wear consisted of at least 7 hours of wear time. | Baseline (0 Weeks), Post-Test (10 Weeks) |
| Program Safety - Number of Adverse Events Related to Study Participation | Any self-reported or observed negative events related to participation. | Baseline (0 Weeks), Post-Test (10 Weeks) |
| Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria | Rate of participant's completion of homework assigned throughout the study. Logs were considered adherent if participants completed 3 home practice components 3 out of 7 days per week or 1 home practice component 5 out of 7 days per week. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Min Walk Test Distance | Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes. | 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks). |
| ActiGraph Average Steps |
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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 |
|---|---|---|---|
| 35231185 | Derived | Hopkins SW, Greenberg J, Isaacs J, Vranceanu AM. "Practice Makes Perfect"? Associations Between Home Practice and Physical and Emotional Function Outcomes Among Patients with Chronic Pain Enrolled in a Mind-Body Program. J Integr Complement Med. 2022 Apr;28(4):320-327. doi: 10.1089/jicm.2021.0324. Epub 2022 Feb 28. | |
| 33649888 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | GetActive | The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness. |
| FG001 | GetActive With Fitbit | The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity. Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GetActive | The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness. |
| 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 | Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint | Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. | Posted | Count of Participants | Participants | Post-Test (10 Weeks) |
|
10 weeks
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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 | GetActive | The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sciatica | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana-Maria Vranceanu | Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital | (617) 724-3953 | 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 | Jan 3, 2020 | Nov 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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|
|
| Get Active with Fitbit | Behavioral | The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity. |
|
|
| Baseline (0 Weeks), Post-Test (10 Weeks) |
| Feasibility of Quantitative Measures | The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments. | Baseline (0 Weeks), Post-Test (10 Weeks) |
| Credibility and Expectancy Questionnaire (CEQ) | Number of participants who score above the midpoint on two subscales assessed using frequencies and proportions. The measure involves two subscales: credibility (questions 1-3) and expectancy (questions 4-6). Subscale scores range from 3 to 27. Higher scores indicate greater perceived credibility and greater belief that treatment will help. | Baseline (0 Weeks) |
| Program Acceptability | Assessed via the percentage of participants who attended at least 7 out of 10 sessions. | Post-Test (10 Weeks) |
Average steps counted for using the wGT3X-BT ActiGraph accelerometer device. Daily step counts were collected using the device for a week at each assessment period. A weekly average was calculated from the daily totals.
| 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks) |
| Patient Global Impression of Change (PGIC) | The PGIC assesses clinically important change in symptoms since beginning treatment. Each of the 6 items assesses a different treatment target. Items are assessed on a scale of 0 to 6. Lower scores indicate greater symptom improvement. | Post-Test (10 Weeks) |
| Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | The PASIPD is a 13-item measure that assesses one's level of physical activity and exercise in the past 7 days. Scores range from 0 to 100. Higher scores indicate greater activity. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| WHO Disability Assessment Schedule 2.0 (WHODAS) | The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100. Higher scores indicate more disability. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Patient-Reported Outcomes Measurement Information System Physical Function v.8b | The 8-item scale assesses for how difficult it is for one to perform daily living activities. Raw scores range from 8 to 40. T scores range from 20.3 to 60.1. Higher scores indicate better physical function and ability to perform activities of daily living. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Patient-Reported Outcomes Measurement Information System Anxiety v.8a | The 8-item scale measures fear and worry over the past week. Raw scores range from 8 to 40. T-scores range from 37.1 to 83.1. Higher scores indicate higher levels of anxiety. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Patient-Reported Outcomes Measurement Information System Depression v.8b | The 8-item scale measures depressive symptoms over the past week. Raw scores range from 8 to 40 and t scores range from 37.1 to 82.4. Higher scores indicate greater depressive symptoms. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Pain Resilience Scale (PRS) | The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain. Scores range from 0 to 56. Higher scores indicate greater resilience. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Numerical Rating Scale | Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Cognitive and Affective Mindfulness Scale (CAMS) | The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings. Items range from 1 to 4. Total scores range from 12 to 48. Higher values reflect higher levels of mindfulness. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Pittsburgh Sleep Quality Index (PSQI) | Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | The 4-item scale measures how often one perceives feeling apart from others and excluded. Raw scores range from 4 to 20. Scaled scores range from 34.8 to 74.2. Higher scores indicate greater social isolation. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | The 4-item scale measures perceived emotional support. Raw scores range from 4 to 20. Scaled scores range from 25.7 to 62. Higher score indicate greater emotional support. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Pain Catastrophizing Scale (PCS) | The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. Total scores range from 0 to 52. A higher score indicates more catastrophizing. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Tampa Kinesiophobia Scale (TKS) | The TKS is a 17-item scale that measures one's fear of movement, with a greater score indicating greater fear of injury due to movement. Scores range from 11 to 44. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Measure of Current Status (MOCS-A) | The MOCS-A, a 13-item scale, measures one's perceived ability to perform various skills that the intervention aims to target. Scores range from 0 to 52. Higher scores indicate greater perceived ability. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
| Greenberg J, Singh T, Popok PJ, Kulich RJ, Vranceanu AM. Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain. Int J Behav Med. 2021 Dec;28(6):820-826. doi: 10.1007/s12529-021-09971-3. Epub 2021 Mar 2. |
| 33574699 | Derived | Greenberg J, Mace RA, Bannon SM, Kulich RJ, Vranceanu AM. Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function. J Pain Res. 2021 Feb 5;14:359-368. doi: 10.2147/JPR.S298212. eCollection 2021. |
| 33540223 | Derived | Bannon S, Greenberg J, Mace RA, Locascio JJ, Vranceanu AM. The role of social isolation in physical and emotional outcomes among patients with chronic pain. Gen Hosp Psychiatry. 2021 Mar-Apr;69:50-54. doi: 10.1016/j.genhosppsych.2021.01.009. Epub 2021 Jan 28. |
| 33469845 | Derived | 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. |
| 32982388 | Derived | Greenberg J, Mace RA, Popok PJ, Kulich RJ, Patel KV, Burns JW, Somers TJ, Keefe FJ, Schatman ME, Vranceanu AM. Psychosocial Correlates of Objective, Performance-Based, and Patient-Reported Physical Function Among Patients with Heterogeneous Chronic Pain. J Pain Res. 2020 Sep 10;13:2255-2265. doi: 10.2147/JPR.S266455. eCollection 2020. |
| 32348281 | Derived | Greenberg J, Popok PJ, Lin A, Kulich RJ, James P, Macklin EA, Millstein RA, Edwards RR, Vranceanu AM. A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e18703. doi: 10.2196/18703. |
| BG001 | GetActive With Fitbit | The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity. Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| OG001 | GetActive With Fitbit | The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity. Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity. |
|
|
| Primary | Therapist Adherence | Two independent coders rated whether clinicians delivered each component of study sessions (e.g., deep breathing, providing education on prevalent myths about chronic pain) , exhibited skillful delivery (e.g., active listening, validation), and followed study protocol (e.g., collecting home practice sheets, logging attendance). Each individual component was rated on a yes/no scale. The adherent ("yes") components were summed, tallied against the total number of components in the adherence checklist, and averaged between the 2 reviewers. The score represents a total rate of adherence. | Posted | Number | percentage of adherence | Collected during the intervention | Components | Components |
|
|
|
| Primary | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Rate of participant's use of ActiGraph watch for a period of one week at both baseline and post-treatment assessments. A valid day of wear consisted of at least 7 hours of wear time. | The number of participants who received an ActiGraph at post-tests was fewer than baselines because of patients discontinuing participation. | Posted | Count of Participants | Participants | Baseline (0 Weeks), Post-Test (10 Weeks) |
|
|
|
| Primary | Program Safety - Number of Adverse Events Related to Study Participation | Any self-reported or observed negative events related to participation. | Posted | Number | adverse events | Baseline (0 Weeks), Post-Test (10 Weeks) |
|
|
|
| Primary | Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria | Rate of participant's completion of homework assigned throughout the study. Logs were considered adherent if participants completed 3 home practice components 3 out of 7 days per week or 1 home practice component 5 out of 7 days per week. | Posted | Count of Participants | Participants | Baseline (0 Weeks), Post-Test (10 Weeks) |
|
|
|
| Primary | Feasibility of Quantitative Measures | The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments. | Posted | Count of Participants | Participants | Baseline (0 Weeks), Post-Test (10 Weeks) |
|
|
|
| Primary | Credibility and Expectancy Questionnaire (CEQ) | Number of participants who score above the midpoint on two subscales assessed using frequencies and proportions. The measure involves two subscales: credibility (questions 1-3) and expectancy (questions 4-6). Subscale scores range from 3 to 27. Higher scores indicate greater perceived credibility and greater belief that treatment will help. | Posted | Count of Participants | Participants | Baseline (0 Weeks) |
|
|
|
| Primary | Program Acceptability | Assessed via the percentage of participants who attended at least 7 out of 10 sessions. | Posted | Count of Participants | Participants | Post-Test (10 Weeks) |
|
|
|
| Secondary | 6-Min Walk Test Distance | Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | Meters | 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks). |
|
|
|
| Secondary | ActiGraph Average Steps | Average steps counted for using the wGT3X-BT ActiGraph accelerometer device. Daily step counts were collected using the device for a week at each assessment period. A weekly average was calculated from the daily totals. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | Steps | 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks) |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) | The PGIC assesses clinically important change in symptoms since beginning treatment. Each of the 6 items assesses a different treatment target. Items are assessed on a scale of 0 to 6. Lower scores indicate greater symptom improvement. | Posted | Mean | Standard Deviation | score on a scale | Post-Test (10 Weeks) |
|
|
|
| Secondary | Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | The PASIPD is a 13-item measure that assesses one's level of physical activity and exercise in the past 7 days. Scores range from 0 to 100. Higher scores indicate greater activity. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | WHO Disability Assessment Schedule 2.0 (WHODAS) | The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100. Higher scores indicate more disability. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Physical Function v.8b | The 8-item scale assesses for how difficult it is for one to perform daily living activities. Raw scores range from 8 to 40. T scores range from 20.3 to 60.1. Higher scores indicate better physical function and ability to perform activities of daily living. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Anxiety v.8a | The 8-item scale measures fear and worry over the past week. Raw scores range from 8 to 40. T-scores range from 37.1 to 83.1. Higher scores indicate higher levels of anxiety. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Depression v.8b | The 8-item scale measures depressive symptoms over the past week. Raw scores range from 8 to 40 and t scores range from 37.1 to 82.4. Higher scores indicate greater depressive symptoms. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Pain Resilience Scale (PRS) | The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain. Scores range from 0 to 56. Higher scores indicate greater resilience. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Numerical Rating Scale | Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Cognitive and Affective Mindfulness Scale (CAMS) | The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings. Items range from 1 to 4. Total scores range from 12 to 48. Higher values reflect higher levels of mindfulness. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | The 4-item scale measures how often one perceives feeling apart from others and excluded. Raw scores range from 4 to 20. Scaled scores range from 34.8 to 74.2. Higher scores indicate greater social isolation. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | The 4-item scale measures perceived emotional support. Raw scores range from 4 to 20. Scaled scores range from 25.7 to 62. Higher score indicate greater emotional support. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Pain Catastrophizing Scale (PCS) | The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. Total scores range from 0 to 52. A higher score indicates more catastrophizing. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Tampa Kinesiophobia Scale (TKS) | The TKS is a 17-item scale that measures one's fear of movement, with a greater score indicating greater fear of injury due to movement. Scores range from 11 to 44. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| Secondary | Measure of Current Status (MOCS-A) | The MOCS-A, a 13-item scale, measures one's perceived ability to perform various skills that the intervention aims to target. Scores range from 0 to 52. Higher scores indicate greater perceived ability. | We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data | Posted | Mean | Standard Error | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 3 |
| 35 |
| EG001 | GetActive With Fitbit | The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity. Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity. | 0 | 37 | 1 | 37 | 7 | 37 |
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient admitted to hospital; suffered falls; celluitis |
|
| Sprained quadricep muscle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lung Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pain Flare | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sickle Cell Anemia Flare | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment | Patient hospitalized for diverticulitis attack |
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| Chemotherapy | Surgical and medical procedures | Non-systematic Assessment | Patient hospitalized for chemotherapy |
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| Hospitalization | General disorders | Non-systematic Assessment | Patient admitted to the hospital for unknown reasons. |
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| Elevated blood pressure and heart rate | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Who received the ActiGraph and wore it for < 5 out of 7 days |
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| Post-Test |
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| Credibility |
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| Posttest |
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| Posttest |
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| Impression of change in physical function |
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| Impression of change in emotional function |
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| Impression of change in resiliency |
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| Impression of change from use of Fitbit |
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| Posttest |
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| Follow up |
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|
| Posttest |
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|
| Follow-up |
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| Posttest |
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|
| Follow-up |
|
|
| Posttest |
|
|
| Follow-up |
|
|
| Posttest |
|
|
| Follow-up |
|
|
| Posttest Pain resilience |
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| 3-Month follow- up Pain resilience |
|
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| Posttest Pain at rest |
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| Follow up Pain at rest |
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| Baseline Pain during activity |
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| Posttest Pain during activity |
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| Follow-up Pain during activity |
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| Posttest Mindfulness |
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| Three-Month follow-up Mindfulness |
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|
| Post-test |
|
|
| Follow up |
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| Post-test |
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|
| Follow-up |
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| Post-test |
|
|
| Follow-up |
|
|
| Posttest |
|
|
| Three-Month follow-up |
|
|
| Posttest |
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| 3-Month follow- up |
|
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| Posttest Adaptive Coping |
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| Three-Month follow-up Adaptive Coping |
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|