The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain

Chronic Pain Clinical Trial

Official title:

The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05700383
• Other study ID #: 2023P000321
• Secondary ID: 1R01AT012069-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female outpatients, age 18 years or older

2. Fluent in English

3. Have nonmalignant chronic musculoskeletal pain for more than 3 months

4. Able to perform a 6-minute walk test (6MWT)

5. Owns a smartphone with Bluetooth 4.0 or computer

6. Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol.

7. 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

8. 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)

1. Sitting for more than 8 hours/day per self-report

2. Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report

3. Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report

Exclusion Criteria:

1. Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)

2. Serious mental illness or instability for which hospitalization may be likely in the next 6 months

3. Current active suicidal ideation reported on self-report

4. Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder

5. Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months

6. Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >45 min 3 times/week within the last 3 months or less.

7. Regular use of Fitbit DMD in the last 3 months

8. Unable to walk/in a wheelchair

9. Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush Medical Center	Chicago	Illinois
United States	Duke University	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Duke University, National Center for Complementary and Integrative Health (NCCIH), Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment feasibility (ability)	Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.	1 Year
Primary	Recruitment feasibility (timeliness)	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 attending Session 1.	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.	1 Year
Primary	Intervention feasibility/ adherence to sessions	=80 chronic pain patients attend =7/10 sessions for each program (70%)	Post-Test (10 Weeks)
Primary	Credibility and Expectancy Scale	=80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention credibility	Baseline (0 Weeks)
Primary	Client Satisfaction Scale	=80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention satisfaction	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).	1 Year
Primary	Assessment feasibility	=90 accuracy of standardized protocol checklists for all assessments.	1 Year
Primary	Adherence to Accelerometer	Daily wear of charged ActiGraph GT9X for GetActive-Fitbit Daily wear of Actigraph accelerometer for baseline and follow-up assessments.	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 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	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, with higher scores indicating more disability.	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.	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).	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, with higher scores indicating more depressive symptoms	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, with higher scores indicating more anxiety symptoms	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	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	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	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	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Secondary	Modified Global Impression of Change (MGIC)	2-item assessing the extent to which patients perceive the intervention improved functioning and symptoms.	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)