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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Health for Older Adults With Pain Through Engagement (Open-pilot)

NCT05782231

Chronic Pain Musculoskeletal Pain

COMPLETED NA

Improving Health for Older Adults With Pain Through Engagement

NCT06119698

Chronic Pain Musculoskeletal Pain

RECRUITING NA

mHealth Intervention to Promote Cancer Survivors' Physical Activity

NCT02469727

Physical Activity Quality of Life

COMPLETED NA

Improving Physical Activity in Young Adult Cancer Survivors

NCT03233581

Physical Activity Quality of Life

COMPLETED NA

Wearable Device to Increase Physical Activity Amongst Adults With Pain

NCT05860478

Musculoskeletal Chronic Pain Conditions

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

GetActive-Fitbit

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Healthy Living for Pain

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes