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

Mass General Brigham

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: GetActive-Fitbit; Behavioral: Healthy Living for Pain

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05700383

2023P000321

1R01AT012069-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

GetActive-Fitbit

Experimental group

Description:

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.

Treatment:

Behavioral: GetActive-Fitbit

Healthy Living for Pain

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Living for Pain