Clinical trial NCT05700383: The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain
Official title: The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Physical Function
Mindfulness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: Duke University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Recruitment feasibility (ability)
timeFrame: 1 Year
measure: Recruitment feasibility (timeliness)
timeFrame: 1 Year
measure: Feasibility of recruitment racial and ethnic minorities
timeFrame: 1 Year
measure: Intervention feasibility/ adherence to sessions
timeFrame: Post-Test (10 Weeks)
measure: Credibility and Expectancy Scale
timeFrame: Baseline (0 Weeks)
measure: Client Satisfaction Scale
timeFrame: Post-Test (10 Weeks)
measure: Retention
timeFrame: 1 Year
measure: Assessment feasibility
timeFrame: 1 Year
measure: Adherence to Accelerometer
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Secondary outcomes:
measure: Pain, Enjoyment of Life and General Activity (PEG-3) Scale
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: WHO Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: 6 Minute Walk Test (6MWT)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: ActiGraph GT9X
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: PROMIS depression v1.08b
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: PROMIS anxiety v1.08a
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: Tampa Kinesiophobia Scale (TSK)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: Measure of Current Status (MOCS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
measure: Modified Global Impression of Change (MGIC)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: