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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05700383

Enrollment

Registered

2023-01-26

Start date

2023-04-01

Completion date

2024-10-01

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic Pain, Physical Function, Mindfulness

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.

Interventions

BEHAVIORALGetActive-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.

BEHAVIORALHealthy 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Recruitment Feasibility (Ability)	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	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	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	Post-Test (10 Weeks)	≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Credibility and Expectancy Scale - Credibility	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	Post-Test (10 Weeks)	≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.
Retention	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	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	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.

Secondary

Measure	Time frame	Description
Pain, Enjoyment of Life and General Activity (PEG-3) Scale	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
WHO Disability Assessment Schedule 2.0 (WHODAS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
6 Minute Walk Test (6MWT)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	The 6MWT is a performance-based measure that assesses physical function and endurance.
ActiGraph GT9X	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
PROMIS Depression v1.08b	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
PROMIS Anxiety v1.08a	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Pain Catastrophizing Scale (PCS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Tampa Kinesiophobia Scale (TSK)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68.
Measure of Current Status (MOCS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Cognitive and Affective Mindfulness Scale (CAMS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Modified Global Impression of Change (MGIC)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAna-Maria Vranceanu, PhD

Massachusetts General Hospital

Participant flow

Participants by arm

Arm	Count
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. 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.	47
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. 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.	45
Total	92

Baseline characteristics

Characteristic	GetActive-Fitbit	Total	Healthy Living for Pain
Age, Continuous	55.1 years STANDARD_DEVIATION 13.6	57.5 years STANDARD_DEVIATION 14.3	60.1 years STANDARD_DEVIATION 14.8
Education Choose Not to Answer	2 Participants	4 Participants	2 Participants
Education Completed 4 years of college	15 Participants	25 Participants	10 Participants
Education Completed high school or GED	12 Participants	18 Participants	6 Participants
Education Graduate/professional degree	6 Participants	15 Participants	9 Participants
Education Less than high school	1 Participants	2 Participants	1 Participants
Education Some college/Associates degree	11 Participants	28 Participants	17 Participants
Employment Choose Not to Answer	4 Participants	7 Participants	3 Participants
Employment Employed full-time	9 Participants	21 Participants	12 Participants
Employment Employed part-time	4 Participants	7 Participants	3 Participants
Employment Keeping House/Housemaker	4 Participants	5 Participants	1 Participants
Employment Other	4 Participants	9 Participants	5 Participants
Employment Retired	14 Participants	30 Participants	16 Participants
Employment Unemployed	8 Participants	13 Participants	5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	5 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants	77 Participants	38 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants	10 Participants	5 Participants
Income $10,000 to less than $15,000	5 Participants	10 Participants	5 Participants
Income $15,000 to less than $20,000	1 Participants	2 Participants	1 Participants
Income $20,000 to less than $25,000	3 Participants	6 Participants	3 Participants
Income $25,000 to less than $35,000	3 Participants	8 Participants	5 Participants
Income $35,000 to less than $50,000	9 Participants	12 Participants	3 Participants
Income $50,000 to less than $75,000	4 Participants	7 Participants	3 Participants
Income $75,000 or more	9 Participants	20 Participants	11 Participants
Income Choose Not to Answer	7 Participants	18 Participants	11 Participants
Income Less than $10,000	6 Participants	9 Participants	3 Participants
Marital Status Choose Not to Answer	3 Participants	5 Participants	2 Participants
Marital Status Living with significant other	1 Participants	3 Participants	2 Participants
Marital Status Married	16 Participants	30 Participants	14 Participants
Marital Status Separated/Divorced	9 Participants	16 Participants	7 Participants
Marital Status Single, never married	16 Participants	29 Participants	13 Participants
Marital Status Widowed	2 Participants	9 Participants	7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Black or African American	21 Participants	41 Participants	20 Participants
Race (NIH/OMB) More than one race	5 Participants	8 Participants	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	4 Participants	1 Participants
Race (NIH/OMB) White	17 Participants	37 Participants	20 Participants
Region of Enrollment United States	47 participants	92 participants	45 participants
Sex: Female, Male Female	37 Participants	69 Participants	32 Participants
Sex: Female, Male Male	10 Participants	23 Participants	13 Participants
Sex/Gender, Customized Gender identity not listed	1 Participants	1 Participants	0 Participants
Sex/Gender, Customized Man	10 Participants	23 Participants	13 Participants
Sex/Gender, Customized Prefer not to say	0 Participants	0 Participants	0 Participants
Sex/Gender, Customized Woman	36 Participants	68 Participants	32 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 47	0 / 45
other Total, other adverse events	11 / 47	16 / 45
serious Total, serious adverse events	6 / 47	1 / 45

Outcome results

Primary

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.

Time frame: 1 Year

Population: There are no arms/groups for this outcome because the benchmark was calculated based on percentage accuracy of assessment study procedures as conducted by staff not participants

Arm	Measure	Value (COUNT_OF_UNITS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Assessment Feasibility	3241 Number of assessment procedures

Primary

Client Satisfaction Scale

≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.

Time frame: Post-Test (10 Weeks)

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Client Satisfaction Scale	scored above the scale midpoint	41 Participants
All Participants (GetActive Fitbit and Healthy Living for Pain)	Client Satisfaction Scale	scored below the scale midpoint	1 Participants
Healthy Living for Pain	Client Satisfaction Scale	scored above the scale midpoint	30 Participants
Healthy Living for Pain	Client Satisfaction Scale	scored below the scale midpoint	10 Participants

Primary

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.

Time frame: Baseline (0 weeks)

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Credibility and Expectancy Questionnaire - Expectancy	scored above the scale midpoint	36 Participants
All Participants (GetActive Fitbit and Healthy Living for Pain)	Credibility and Expectancy Questionnaire - Expectancy	scored below the scale midpoint	6 Participants
Healthy Living for Pain	Credibility and Expectancy Questionnaire - Expectancy	scored above the scale midpoint	26 Participants
Healthy Living for Pain	Credibility and Expectancy Questionnaire - Expectancy	scored below the scale midpoint	13 Participants

Primary

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.

Time frame: Baseline (0 Weeks)

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Credibility and Expectancy Scale - Credibility	scored below the scale midpoint	0 Participants
All Participants (GetActive Fitbit and Healthy Living for Pain)	Credibility and Expectancy Scale - Credibility	scored above the scale midpoint	41 Participants
Healthy Living for Pain	Credibility and Expectancy Scale - Credibility	scored below the scale midpoint	5 Participants
Healthy Living for Pain	Credibility and Expectancy Scale - Credibility	scored above the scale midpoint	34 Participants

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.

Time frame: 1 Year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Feasibility of Recruitment Racial and Ethnic Minorities	50 Participants

Primary

Intervention Feasibility/ Adherence to Sessions

≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)

Time frame: Post-Test (10 Weeks)

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Intervention Feasibility/ Adherence to Sessions	Attended ≥7 out of 10 group or make-up sessions	44 Participants
All Participants (GetActive Fitbit and Healthy Living for Pain)	Intervention Feasibility/ Adherence to Sessions	Attended <7 out of 10 group or make-up sessions	2 Participants
Healthy Living for Pain	Intervention Feasibility/ Adherence to Sessions	Attended ≥7 out of 10 group or make-up sessions	37 Participants
Healthy Living for Pain	Intervention Feasibility/ Adherence to Sessions	Attended <7 out of 10 group or make-up sessions	8 Participants

Primary

Recruitment Feasibility (Ability)

Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.

Time frame: 1 Year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Recruitment Feasibility (Ability)	92 Participants

Primary

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.

Time frame: 1 Year

Population: Arms are combined because benchmark is calculated prior to participant randomization to treatment group

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year	92 Participants

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).

Time frame: Post-test (10 weeks), Follow-up (24 weeks)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
All Participants (GetActive Fitbit and Healthy Living for Pain)	Retention	Post-Test	Completed self-report, performance-based, and objective data with valid data	44 Participants
All Participants (GetActive Fitbit and Healthy Living for Pain)	Retention	Post-Test	Did not complete self-report, performance-based, and objective data with valid data	3 Participants
All Participants (GetActive Fitbit and Healthy Living for Pain)	Retention	Follow-Up	Completed self-report, performance-based, and objective data with valid data	41 Participants
All Participants (GetActive Fitbit and Healthy Living for Pain)	Retention	Follow-Up	Did not complete self-report, performance-based, and objective data with valid data	6 Participants
Healthy Living for Pain	Retention	Follow-Up	Did not complete self-report, performance-based, and objective data with valid data	8 Participants
Healthy Living for Pain	Retention	Post-Test	Completed self-report, performance-based, and objective data with valid data	39 Participants
Healthy Living for Pain	Retention	Follow-Up	Completed self-report, performance-based, and objective data with valid data	37 Participants
Healthy Living for Pain	Retention	Post-Test	Did not complete self-report, performance-based, and objective data with valid data	6 Participants

Secondary