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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT012069-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
| Duke University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program compared to a health education program for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.
The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program (GetActive-Fitbit) compared to a health education program (Healthy Living for Pain) for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.
Each program will consist of ten 60-minute sessions in-person. Participants will receive a treatment manual and ActiGraph watch to assess physical function. There are 3 assessment points consisting of self-report surveys and performance-based measures: baseline, post-program, and 6-month follow-up. All participants will receive access to the other program's manual and website after completing the six-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GetActive-Fitbit | Experimental | GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. |
|
| Healthy Living for Pain | Active Comparator | Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GetActive-Fitbit | Behavioral | GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility (Ability) | Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria. | 1 Year |
| Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year | Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year. Participants will be considered enrolled upon randomization. Assessed by the number of participants enrolled in the study over the course of 1 year. If number enrolled meets or exceeds goal of 90 participants, the benchmark is considered met. | 1 Year |
| Feasibility of Recruitment Racial and Ethnic Minorities | 38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution. | 1 Year |
| Intervention Feasibility/ Adherence to Sessions | ≥80 chronic pain patients attend ≥7/10 sessions for each program (70%) | Post-Test (10 Weeks) |
| Credibility and Expectancy Scale - Credibility | ≥80 chronic pain patients with credibility scores higher than the Credibility and Expectancy Scale credibility subscale's mid-point, indicating intervention credibility. Credibility subscale scores range from 3 to 27. Higher scores indicate higher perceived credibility for the program. | Baseline (0 Weeks) |
| Client Satisfaction Scale | ≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, Enjoyment of Life and General Activity (PEG-3) Scale | Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale. Scores range from 0-30 with higher scores indicating greater pain and interference. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
Not provided
Inclusion Criteria:
Male and female outpatients, age 18 years or older
Fluent in English
Have nonmalignant chronic musculoskeletal pain for more than 3 months
Able to perform a 6-minute walk test (6MWT)
Owns a smartphone with Bluetooth 4.0 or computer
Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol.
Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
Low-level of activity (must meet 2/3 criteria; if difficult to assess, recruiter may ask participant to report their recent step data from their smartphone to better understand their activity level)
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 |
|---|---|---|---|---|---|---|
| Rush Medical Center | Chicago | Illinois | 60612 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40522662 | Derived | Greenberg J, Hooker JE, McDermott KA, La Camera DE, Brewer JR, Szapary CL, Somers TJ, Keefe F, Kelleher SA, Fisher HM, Burns J, Jeddi R, Kulich R, Polykoff GI, Parker RA, Vranceanu AM; THRIVE Study Team; Diachina A, Hogan S, Chou N, Yates L. Feasibility of a Mind-Body Program for Chronic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2515685. doi: 10.1001/jamanetworkopen.2025.15685. | |
| 38286223 | Derived | Hooker JE, Brewer JR, McDermott KA, Kanaya M, Somers TJ, Keefe F, Kelleher S, Fisher HM, Burns J, Jeddi RW, Kulich R, Polykoff G, Parker RA; THRIVE Study Team; Greenberg J, Vranceanu AM. Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT. Contemp Clin Trials. 2024 Mar;138:107462. doi: 10.1016/j.cct.2024.107462. Epub 2024 Jan 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GetActive-Fitbit | GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. GetActive-Fitbit: GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. |
| FG001 | Healthy Living for Pain | Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. Healthy Living for Pain: Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GetActive-Fitbit | GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. GetActive-Fitbit: GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Recruitment Feasibility (Ability) | Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria. | Posted | Count of Participants | Participants | 1 Year |
|
|
9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GetActive-Fitbit | GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. GetActive-Fitbit: GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Active Suicidality | Psychiatric disorders | Non-systematic Assessment | Report of recent, aborted suicide attempt |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Irritation on wrist after smart-watch wear |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | 617-724-4977 | avranceanu@mgh.harvard.edu |
Not provided
| 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 | Mar 21, 2024 | Mar 13, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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Not provided
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|
| Healthy Living for Pain | Behavioral | Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. |
|
| Post-Test (10 Weeks) |
| Retention | ≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants). | Post-test (10 weeks), Follow-up (24 weeks) |
| Assessment Feasibility | We calculated the proportion of assessment procedures that were administered as intended in the the checklists of the study protocol. The number of assessment procedures that were administered in line with the study's protocol checklists was divided by the total number of assessment procedures. The benchmark was set to 90%, i.e., assessment procedures were deemed feasible if ≥90% of assessment procedures were delivered as specified in the protocol. | 1 Year |
| Credibility and Expectancy Questionnaire - Expectancy | ≥80 chronic pain patients with expectancy scores higher than the subscale's mid-point, indicating intervention expectancy. Expectancy subscale scores range from 3 to 27. Higher scores indicate more belief that treatment will help. | Baseline (0 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. Each question on the scale is measured 0-4. The score range is 0-100, with higher scores indicating more disability. |
| Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| 6 Minute Walk Test (6MWT) | The 6MWT is a performance-based measure that assesses physical function and endurance. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| ActiGraph GT9X | The ActiGraph GT9X is a step count device that objectively measures function (number of steps). | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| PROMIS Depression v1.08b | The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale. Raw scores are converted into a t-score with a mean of 50 and standard deviation of 10. Higher scores indicate more depressive symptoms. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| PROMIS Anxiety v1.08a | The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms. Each item is rated on a 1-5 point Likert Scale and raw scores are converted to t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicating more anxiety symptoms. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| Pain Catastrophizing Scale (PCS) | A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Higher scores indicate higher pain catastrophizing. Scores range from 0 to 52. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| Tampa Kinesiophobia Scale (TSK) | A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| 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). Higher scores indicate a stronger ability to recognize stress and cope, with scores ranging from 10 to 50. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| Cognitive and Affective Mindfulness Scale (CAMS) | Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness. Scores range from 12 to 48. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| Modified Global Impression of Change (MGIC) | 3-items assessing the extent to which patients perceive the intervention improved functioning and symptoms. Each item is rated on a 1-7 point scale with higher scores indicated greater perceived improvement. | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| BG001 | Healthy Living for Pain | Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. Healthy Living for Pain: Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
|
| Primary | Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year | Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year. Participants will be considered enrolled upon randomization. Assessed by the number of participants enrolled in the study over the course of 1 year. If number enrolled meets or exceeds goal of 90 participants, the benchmark is considered met. | Arms are combined because benchmark is calculated prior to participant randomization to treatment group | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Primary | Feasibility of Recruitment Racial and Ethnic Minorities | 38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution. | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Primary | Intervention Feasibility/ Adherence to Sessions | ≥80 chronic pain patients attend ≥7/10 sessions for each program (70%) | Posted | Count of Participants | Participants | Post-Test (10 Weeks) |
|
|
|
| Primary | Credibility and Expectancy Scale - Credibility | ≥80 chronic pain patients with credibility scores higher than the Credibility and Expectancy Scale credibility subscale's mid-point, indicating intervention credibility. Credibility subscale scores range from 3 to 27. Higher scores indicate higher perceived credibility for the program. | Posted | Count of Participants | Participants | Baseline (0 Weeks) |
|
|
|
| Primary | Client Satisfaction Scale | ≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction. | Posted | Count of Participants | Participants | Post-Test (10 Weeks) |
|
|
|
| Primary | Retention | ≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants). | Posted | Count of Participants | Participants | Post-test (10 weeks), Follow-up (24 weeks) |
|
|
|
| Primary | Assessment Feasibility | We calculated the proportion of assessment procedures that were administered as intended in the the checklists of the study protocol. The number of assessment procedures that were administered in line with the study's protocol checklists was divided by the total number of assessment procedures. The benchmark was set to 90%, i.e., assessment procedures were deemed feasible if ≥90% of assessment procedures were delivered as specified in the protocol. | There are no arms/groups for this outcome because the benchmark was calculated based on percentage accuracy of assessment study procedures as conducted by staff not participants | Posted | Count of Units | Number of assessment procedures | 1 Year | Number of assessment procedures | Number of assessment procedures |
|
|
|
| Primary | Credibility and Expectancy Questionnaire - Expectancy | ≥80 chronic pain patients with expectancy scores higher than the subscale's mid-point, indicating intervention expectancy. Expectancy subscale scores range from 3 to 27. Higher scores indicate more belief that treatment will help. | Posted | Count of Participants | Participants | Baseline (0 weeks) |
|
|
|
| Secondary | Pain, Enjoyment of Life and General Activity (PEG-3) Scale | Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale. Scores range from 0-30 with higher scores indicating greater pain and interference. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 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. Each question on the scale is measured 0-4. The score range is 0-100, with higher scores indicating more disability. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | 6 Minute Walk Test (6MWT) | The 6MWT is a performance-based measure that assesses physical function and endurance. | The number of participants who completed post-test and follow-up assessments was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | meters | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | ActiGraph GT9X | The ActiGraph GT9X is a step count device that objectively measures function (number of steps). | The number of participants who received an ActiGraph at post-test and follow-up was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | Steps | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | PROMIS Depression v1.08b | The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale. Raw scores are converted into a t-score with a mean of 50 and standard deviation of 10. Higher scores indicate more depressive symptoms. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | PROMIS Anxiety v1.08a | The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms. Each item is rated on a 1-5 point Likert Scale and raw scores are converted to t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicating more anxiety symptoms. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | Pain Catastrophizing Scale (PCS) | A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Higher scores indicate higher pain catastrophizing. Scores range from 0 to 52. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | Tampa Kinesiophobia Scale (TSK) | A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| 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). Higher scores indicate a stronger ability to recognize stress and cope, with scores ranging from 10 to 50. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | Cognitive and Affective Mindfulness Scale (CAMS) | Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness. Scores range from 12 to 48. | The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| Secondary | Modified Global Impression of Change (MGIC) | 3-items assessing the extent to which patients perceive the intervention improved functioning and symptoms. Each item is rated on a 1-7 point scale with higher scores indicated greater perceived improvement. | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks) |
|
|
|
| 0 |
| 47 |
| 6 |
| 47 |
| 11 |
| 47 |
| EG001 | Healthy Living for Pain | Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. Healthy Living for Pain: Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling. | 0 | 45 | 1 | 45 | 16 | 45 |
|
| Hospitalization for high blood pressure | Blood and lymphatic system disorders | Non-systematic Assessment | Prolonged hospitalization to manage high blood pressure |
|
| Kidney Transplant | Renal and urinary disorders | Non-systematic Assessment | Received a kidney transplant for chronic kidney disease |
|
| Hospitalization for blood clot | Blood and lymphatic system disorders | Non-systematic Assessment | Loss of consciousness and subsequent hospitalization for blood clot in the lungs |
|
| Hospitalization for migraine | General disorders | Non-systematic Assessment | Hospitalized for severe migraine; received lidocaine shots |
|
| Hospitalization for neurological symptoms | Nervous system disorders | Non-systematic Assessment | Admitted to hospital for stroke-like symptoms |
|
| Cerebrovascular accident | Vascular disorders | Non-systematic Assessment |
|
| Hospitalization for lumbar surgery | Surgical and medical procedures | Non-systematic Assessment | Repeated unsuccessful lumbar procedures |
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| Hospitalization after emergency room visit | General disorders | Non-systematic Assessment | Four ER trips with three subsequent hospitalizations |
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| Emergency room visit for pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | ER visit for intense pain that did not result in hospitalization |
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| Emergency room visit for urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Musculoskeletal pain/injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Kidney injury or infection | Renal and urinary disorders | Non-systematic Assessment |
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| Adverse reaction to medical procedure | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Toxic Multinodular Goiter | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Distress related to intervention homework | Psychiatric disorders | Non-systematic Assessment |
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| Autoimmune disease diagnosis | Immune system disorders | Non-systematic Assessment |
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| Passive death ideation | Psychiatric disorders | Non-systematic Assessment |
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| Motor vehicle collision | General disorders | Non-systematic Assessment |
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| Severe rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
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| Partial psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Fall | General disorders | Non-systematic Assessment |
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| Outpatient procedure | Surgical and medical procedures | Non-systematic Assessment |
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| Global Impressions of Change: Emotional Wellbeing |
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