Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain; Multi-site Feasibility RCT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program (GetActive with Steps!) 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GetActive with Steps! GetActive with Steps! 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 with Steps! 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. |
Behavioral: GetActive with Steps!
GetActive with Steps! 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 with Steps! 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.
|
| Active Comparator: Healthy Living for Pain Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive with Steps! 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. |
Behavioral: Healthy Living for Pain
Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive with Steps! 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.
|
Outcome Measures
Primary Outcome Measures
- Recruitment feasibility (ability) [1 Year]
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
- Recruitment feasibility (timeliness) [1 Year]
Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year.
- Feasibility of recruitment racial and ethnic minorities [1 Year]
38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.
- Intervention feasibility/ adherence to sessions [Post-Test (10 Weeks)]
≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
- Credibility and Expectancy Scale [Baseline (0 Weeks)]
≥80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention credibility
- Client Satisfaction Scale [Post-Test (10 Weeks)]
≥80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention satisfaction
- Retention [1 Year]
≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).
- Assessment feasibility [1 Year]
≥90 accuracy of standardized protocol checklists for all assessments.
- Adherence to Accelerometer [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
Daily wear of charged ActiGraph GT9X for GetActive with Steps! Daily wear of Actigraph accelerometer for baseline and follow-up assessments.
Secondary Outcome Measures
- Pain, Enjoyment of Life and General Activity (PEG-3) Scale [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale
- WHO Disability Assessment Schedule 2.0 (WHODAS) [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
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, with higher scores indicating more disability.
- 6 Minute Walk Test (6MWT) [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
The 6MWT is a performance-based measure that assesses physical function and endurance.
- ActiGraph GT9X [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
- PROMIS depression v1.08b [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale, with higher scores indicating more depressive symptoms
- PROMIS anxiety v1.08a [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms, with higher scores indicating more anxiety symptoms
- Pain Catastrophizing Scale (PCS) [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
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
- Tampa Kinesiophobia Scale (TSK) [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia
- Measure of Current Status (MOCS) [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
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
- Cognitive and Affective Mindfulness Scale (CAMS) [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness
- Modified Global Impression of Change (MGIC) [Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)]
2-item assessing the extent to which patients perceive the intervention improved functioning and symptoms.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female outpatients, age 18 years or older
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Have nonmalignant chronic musculoskeletal pain for more than 3 months
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Able to perform a 6-minute walk test (6MWT)
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Owns a smartphone with Bluetooth 4.0 or computer
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Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol
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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
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Cleared by a medical doctor for study participation
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Sedentary, as assessed by meeting at least 2 of the following 3 self-reported criteria:
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sitting for more than 8 hours/day
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Not engaged in >30 min/day exercise 3 or more times/week for the past month
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Not walking > 30 minutes/day for the past month
Exclusion Criteria:
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Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
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Serious mental illness or instability for which hospitalization may be likely in the next 6 months
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Current suicidal ideation reported on self-report
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Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, current substance abuse or dependence
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Current substance abuse or dependence, and current alcohol dependence within the past 6 months
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Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >30 min 3 times/week within the last 3 months or less. Regular use of Fitbit DMD in the last 3 months.
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Unable to walk/in a wheelchair
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Mild cognitive decline (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Massachusetts General Hospital
- Rush University Medical Center
- Duke University
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022P003418
- 1R01AT012069-01