Chronic PainNCT05700383
The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain
A study testing GetActive-Fitbit and Healthy Living for Pain in people with Chronic Pain, run by Massachusetts General Hospital at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- GetActive-Fitbit and Healthy Living for Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female outpatients, age 18 years or older
- Fluent in English
- Have nonmalignant chronic musculoskeletal pain for more than 3 months
- Able to perform a 6-minute walk test (6MWT)
- Owns a smartphone with Bluetooth 4.0 or computer
- Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol.
Show all 11Show fewer
- 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
- 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)
- Sitting for more than 8 hours/day per self-report
- Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report
- Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report
Who cannot join
- Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
- Serious mental illness or instability for which hospitalization may be likely in the next 6 months
- Current active suicidal ideation reported on self-report
- Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder
- Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months
- 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.
Show all 9Show fewer
- Regular use of Fitbit DMD in the last 3 months
- Unable to walk/in a wheelchair
- Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rush Medical Center
Chicago, Illinois, 60612
Duke University
Durham, North Carolina, 27705
About this study
Official title: The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- GetActive-Fitbit, Healthy Living for Pain
- Keywords
- Chronic Pain, Physical Function, Mindfulness
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetActive-FitbitBehavioural
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 PainBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GetActive-Fitbit | Experimental | 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. Receives: Behavioral: GetActive-Fitbit |
| Healthy Living for Pain | Active comparator | 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. Receives: Behavioral: Healthy Living for Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility (Ability)
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Measured: 1 Year
Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year
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 randomization. Assessed by the number of participants enrolled in the study over the course of 1 year. If number enrolled meets or exceeds goal of 90 participants, the benchmark is considered met.
Measured: 1 Year
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.
Measured: 1 Year
Intervention Feasibility/ Adherence to Sessions
≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Measured: Post-Test (10 Weeks)
Credibility and Expectancy Scale - Credibility
≥80 chronic pain patients with credibility scores higher than the Credibility and Expectancy Scale credibility subscale's mid-point, indicating intervention credibility. Credibility subscale scores range from 3 to 27. Higher scores indicate higher perceived credibility for the program.
Measured: Baseline (0 Weeks)
Client Satisfaction Scale
≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.
Measured: Post-Test (10 Weeks)
Retention
≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).
Measured: Post-test (10 weeks), Follow-up (24 weeks)
Assessment Feasibility
We calculated the proportion of assessment procedures that were administered as intended in the the checklists of the study protocol. The number of assessment procedures that were administered in line with the study's protocol checklists was divided by the total number of assessment procedures. The benchmark was set to 90%, i.e., assessment procedures were deemed feasible if ≥90% of assessment procedures were delivered as specified in the protocol.
Measured: 1 Year
Credibility and Expectancy Questionnaire - Expectancy
≥80 chronic pain patients with expectancy scores higher than the subscale's mid-point, indicating intervention expectancy. Expectancy subscale scores range from 3 to 27. Higher scores indicate more belief that treatment will help.
Measured: Baseline (0 weeks)
Secondary outcomes (11)
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. Scores range from 0-30 with higher scores indicating greater pain and interference.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
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. The score range is 0-100, with higher scores indicating more disability.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
6 Minute Walk Test (6MWT)
The 6MWT is a performance-based measure that assesses physical function and endurance.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
ActiGraph GT9X
The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS Depression v1.08b
The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale. Raw scores are converted into a t-score with a mean of 50 and standard deviation of 10. Higher scores indicate more depressive symptoms.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS Anxiety v1.08a
The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms. Each item is rated on a 1-5 point Likert Scale and raw scores are converted to t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicating more anxiety symptoms.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
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. Scores range from 0 to 52.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Tampa Kinesiophobia Scale (TSK)
A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
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, with scores ranging from 10 to 50.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
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. Scores range from 12 to 48.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Modified Global Impression of Change (MGIC)
3-items assessing the extent to which patients perceive the intervention improved functioning and symptoms. Each item is rated on a 1-7 point scale with higher scores indicated greater perceived improvement.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, Duke University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700383
- Sponsor's protocol ID
- 2023P000321
- Other IDs
- 1R01AT012069-01
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2023
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greenberg J, Hooker JE, McDermott KA, La Camera DE, Brewer JR, Szapary CL, Somers TJ, Keefe F, Kelleher SA, Fisher HM, Burns J, Jeddi R, Kulich R, Polykoff GI, Parker RA, Vranceanu AM; THRIVE Study Team; Diachina A, Hogan S, Chou N, Yates L. Feasibility of a Mind-Body Program for Chronic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2515685. doi: 10.1001/jamanetworkopen.2025.15685.
PubMed 40522662Hooker JE, Brewer JR, McDermott KA, Kanaya M, Somers TJ, Keefe F, Kelleher S, Fisher HM, Burns J, Jeddi RW, Kulich R, Polykoff G, Parker RA; THRIVE Study Team; Greenberg J, Vranceanu AM. Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT. Contemp Clin Trials. 2024 Mar;138:107462. doi: 10.1016/j.cct.2024.107462. Epub 2024 Jan 28.
PubMed 38286223
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT
- ClinicalTrials.gov ID
- NCT05700383
- Acronym / sponsor ID
- 2023P000321
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Physical Function, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Rush University Medical Center, Duke University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GetActive-Fitbit | Experimental | Behavioral: GetActive-FitbitGetActive-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 | Active comparator | Behavioral: Healthy Living for PainHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female outpatients, age 18 years or older
- Fluent in English
- Have nonmalignant chronic musculoskeletal pain for more than 3 months
- Able to perform a 6-minute walk test (6MWT)
- Owns a smartphone with Bluetooth 4.0 or computer
Key exclusion criteria (9 listed)
- Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
- Serious mental illness or instability for which hospitalization may be likely in the next 6 months
- Current active suicidal ideation reported on self-report
- Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder
- Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GetActive-FitbitGetActive-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. | Behavioural | GetActive-Fitbit |
| Healthy Living for PainHealthy 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. | Behavioural | Healthy Living for Pain |
Primary outcome
Recruitment Feasibility (Ability)
Time frame: 1 Year
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year
Time frame: 1 Year
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 randomization. Assessed by the number of participants enrolled in the study over the course of 1 year. If number enrolled meets or exceeds goal of 90 participants, the benchmark is considered met.
Feasibility of Recruitment Racial and Ethnic Minorities
Time frame: 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
Time frame: Post-Test (10 Weeks)
≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Credibility and Expectancy Scale - Credibility
Time frame: Baseline (0 Weeks)
≥80 chronic pain patients with credibility scores higher than the Credibility and Expectancy Scale credibility subscale's mid-point, indicating intervention credibility. Credibility subscale scores range from 3 to 27. Higher scores indicate higher perceived credibility for the program.
Client Satisfaction Scale
Time frame: Post-Test (10 Weeks)
≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.
Retention
Time frame: Post-test (10 weeks), Follow-up (24 weeks)
≥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
Time frame: 1 Year
We calculated the proportion of assessment procedures that were administered as intended in the the checklists of the study protocol. The number of assessment procedures that were administered in line with the study's protocol checklists was divided by the total number of assessment procedures. The benchmark was set to 90%, i.e., assessment procedures were deemed feasible if ≥90% of assessment procedures were delivered as specified in the protocol.
Credibility and Expectancy Questionnaire - Expectancy
Time frame: Baseline (0 weeks)
≥80 chronic pain patients with expectancy scores higher than the subscale's mid-point, indicating intervention expectancy. Expectancy subscale scores range from 3 to 27. Higher scores indicate more belief that treatment will help.
11 secondary outcomes
Pain, Enjoyment of Life and General Activity (PEG-3) Scale
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
6 Minute Walk Test (6MWT)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
ActiGraph GT9X
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS Depression v1.08b
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS Anxiety v1.08a
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Tampa Kinesiophobia Scale (TSK)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Measure of Current Status (MOCS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Cognitive and Affective Mindfulness Scale (CAMS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Modified Global Impression of Change (MGIC)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40522662Greenberg J, Hooker JE, McDermott KA, La Camera DE, Brewer JR, Szapary CL, Somers TJ, Keefe F, Kelleher SA, Fisher HM, Burns J, Jeddi R, Kulich R, Polykoff GI, Parker RA, Vranceanu AM; THRIVE Study Team; Diachina A, Hogan S, Chou N, Yates L. Feasibility of a Mind-Body Program for Chronic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2515685. doi: 10.1001/jamanetworkopen.2025.15685.
- Derived from this study: PubMed 38286223Hooker JE, Brewer JR, McDermott KA, Kanaya M, Somers TJ, Keefe F, Kelleher S, Fisher HM, Burns J, Jeddi RW, Kulich R, Polykoff G, Parker RA; THRIVE Study Team; Greenberg J, Vranceanu AM. Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT. Contemp Clin Trials. 2024 Mar;138:107462. doi: 10.1016/j.cct.2024.107462. Epub 2024 Jan 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GetActive-Fitbit and Healthy Living for Pain in people with Chronic Pain, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (Ability) (time frame: 1 Year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.