Trial Outcomes & Findings for The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain (NCT NCT05700383)
NCT ID: NCT05700383
Last Updated: 2026-01-28
Results Overview
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
1 Year
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
|
Overall Study
COMPLETED
|
43
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain
Baseline characteristics by cohort
| Measure |
GetActive-Fitbit
n=47 Participants
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.
|
Healthy Living for Pain
n=45 Participants
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.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 13.6 • n=158 Participants
|
60.1 years
STANDARD_DEVIATION 14.8 • n=157 Participants
|
57.5 years
STANDARD_DEVIATION 14.3 • n=315 Participants
|
|
Sex/Gender, Customized
Man
|
10 Participants
n=158 Participants
|
13 Participants
n=157 Participants
|
23 Participants
n=315 Participants
|
|
Sex/Gender, Customized
Woman
|
36 Participants
n=158 Participants
|
32 Participants
n=157 Participants
|
68 Participants
n=315 Participants
|
|
Sex/Gender, Customized
Gender identity not listed
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Sex/Gender, Customized
Prefer not to say
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=158 Participants
|
32 Participants
n=157 Participants
|
69 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=158 Participants
|
13 Participants
n=157 Participants
|
23 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
5 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=158 Participants
|
38 Participants
n=157 Participants
|
77 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
10 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=158 Participants
|
20 Participants
n=157 Participants
|
41 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=158 Participants
|
20 Participants
n=157 Participants
|
37 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
8 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=158 Participants
|
45 participants
n=157 Participants
|
92 participants
n=315 Participants
|
|
Education
Less than high school
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Education
Completed high school or GED
|
12 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
18 Participants
n=315 Participants
|
|
Education
Some college/Associates degree
|
11 Participants
n=158 Participants
|
17 Participants
n=157 Participants
|
28 Participants
n=315 Participants
|
|
Education
Completed 4 years of college
|
15 Participants
n=158 Participants
|
10 Participants
n=157 Participants
|
25 Participants
n=315 Participants
|
|
Education
Graduate/professional degree
|
6 Participants
n=158 Participants
|
9 Participants
n=157 Participants
|
15 Participants
n=315 Participants
|
|
Education
Choose Not to Answer
|
2 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
|
Employment
Employed full-time
|
9 Participants
n=158 Participants
|
12 Participants
n=157 Participants
|
21 Participants
n=315 Participants
|
|
Employment
Employed part-time
|
4 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=315 Participants
|
|
Employment
Keeping House/Housemaker
|
4 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
5 Participants
n=315 Participants
|
|
Employment
Other
|
4 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Employment
Retired
|
14 Participants
n=158 Participants
|
16 Participants
n=157 Participants
|
30 Participants
n=315 Participants
|
|
Employment
Unemployed
|
8 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
13 Participants
n=315 Participants
|
|
Employment
Choose Not to Answer
|
4 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=315 Participants
|
|
Income
Less than $10,000
|
6 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Income
$10,000 to less than $15,000
|
5 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
10 Participants
n=315 Participants
|
|
Income
$15,000 to less than $20,000
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Income
$20,000 to less than $25,000
|
3 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
6 Participants
n=315 Participants
|
|
Income
$25,000 to less than $35,000
|
3 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
8 Participants
n=315 Participants
|
|
Income
$35,000 to less than $50,000
|
9 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
12 Participants
n=315 Participants
|
|
Income
$50,000 to less than $75,000
|
4 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=315 Participants
|
|
Income
$75,000 or more
|
9 Participants
n=158 Participants
|
11 Participants
n=157 Participants
|
20 Participants
n=315 Participants
|
|
Income
Choose Not to Answer
|
7 Participants
n=158 Participants
|
11 Participants
n=157 Participants
|
18 Participants
n=315 Participants
|
|
Marital Status
Single, never married
|
16 Participants
n=158 Participants
|
13 Participants
n=157 Participants
|
29 Participants
n=315 Participants
|
|
Marital Status
Married
|
16 Participants
n=158 Participants
|
14 Participants
n=157 Participants
|
30 Participants
n=315 Participants
|
|
Marital Status
Living with significant other
|
1 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
|
Marital Status
Separated/Divorced
|
9 Participants
n=158 Participants
|
7 Participants
n=157 Participants
|
16 Participants
n=315 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=158 Participants
|
7 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Marital Status
Choose Not to Answer
|
3 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
5 Participants
n=315 Participants
|
PRIMARY outcome
Timeframe: 1 YearAbility to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=132 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
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.
|
|---|---|---|
|
Recruitment Feasibility (Ability)
|
92 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 YearPopulation: Arms are combined because benchmark is calculated prior to participant randomization to treatment group
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=92 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
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.
|
|---|---|---|
|
Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year
|
92 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 Year38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=92 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
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.
|
|---|---|---|
|
Feasibility of Recruitment Racial and Ethnic Minorities
|
50 Participants
|
—
|
PRIMARY outcome
Timeframe: Post-Test (10 Weeks)≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=46 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
Intervention Feasibility/ Adherence to Sessions
Attended ≥7 out of 10 group or make-up sessions
|
44 Participants
|
37 Participants
|
|
Intervention Feasibility/ Adherence to Sessions
Attended <7 out of 10 group or make-up sessions
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=41 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=39 Participants
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.
|
|---|---|---|
|
Credibility and Expectancy Scale - Credibility
scored above the scale midpoint
|
41 Participants
|
34 Participants
|
|
Credibility and Expectancy Scale - Credibility
scored below the scale midpoint
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Post-Test (10 Weeks)≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=42 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=40 Participants
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.
|
|---|---|---|
|
Client Satisfaction Scale
scored above the scale midpoint
|
41 Participants
|
30 Participants
|
|
Client Satisfaction Scale
scored below the scale midpoint
|
1 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
Retention
Post-Test · Completed self-report, performance-based, and objective data with valid data
|
44 Participants
|
39 Participants
|
|
Retention
Post-Test · Did not complete self-report, performance-based, and objective data with valid data
|
3 Participants
|
6 Participants
|
|
Retention
Follow-Up · Completed self-report, performance-based, and objective data with valid data
|
41 Participants
|
37 Participants
|
|
Retention
Follow-Up · Did not complete self-report, performance-based, and objective data with valid data
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: 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
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=3427 Number of assessment procedures
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
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.
|
|---|---|---|
|
Assessment Feasibility
|
3241 Number of assessment procedures
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=42 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=39 Participants
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.
|
|---|---|---|
|
Credibility and Expectancy Questionnaire - Expectancy
scored above the scale midpoint
|
36 Participants
|
26 Participants
|
|
Credibility and Expectancy Questionnaire - Expectancy
scored below the scale midpoint
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=46 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
Pain, Enjoyment of Life and General Activity (PEG-3) Scale
Post-Test
|
5.05 score on a scale
Standard Deviation 2.41
|
5.89 score on a scale
Standard Deviation 2.26
|
|
Pain, Enjoyment of Life and General Activity (PEG-3) Scale
Follow-Up
|
4.61 score on a scale
Standard Deviation 2.04
|
5.27 score on a scale
Standard Deviation 2.52
|
|
Pain, Enjoyment of Life and General Activity (PEG-3) Scale
Baseline
|
6.36 score on a scale
Standard Deviation 2.05
|
6.72 score on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=44 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
WHO Disability Assessment Schedule 2.0 (WHODAS)
Baseline
|
48.79 score on a scale
Standard Deviation 22.35
|
44.86 score on a scale
Standard Deviation 25.04
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS)
Post-Test
|
35.21 score on a scale
Standard Deviation 19.09
|
39.24 score on a scale
Standard Deviation 26.02
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS)
Follow-Up
|
34.61 score on a scale
Standard Deviation 25.03
|
36.93 score on a scale
Standard Deviation 25.57
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up assessments was fewer than baselines because of patients discontinuing participation.
The 6MWT is a performance-based measure that assesses physical function and endurance.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
6 Minute Walk Test (6MWT)
Baseline
|
289.62 meters
Standard Deviation 77.61
|
260.28 meters
Standard Deviation 76.26
|
|
6 Minute Walk Test (6MWT)
Post-Test
|
339.20 meters
Standard Deviation 80.32
|
307.37 meters
Standard Deviation 80.11
|
|
6 Minute Walk Test (6MWT)
Follow-Up
|
316.71 meters
Standard Deviation 77.22
|
299.74 meters
Standard Deviation 74.87
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who received an ActiGraph at post-test and follow-up was fewer than baselines because of patients discontinuing participation.
The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=46 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=44 Participants
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.
|
|---|---|---|
|
ActiGraph GT9X
Baseline
|
2641.43 Steps
Standard Deviation 1735.57
|
3177.11 Steps
Standard Deviation 2573.83
|
|
ActiGraph GT9X
Post-Test
|
3694.77 Steps
Standard Deviation 2175.43
|
3032.90 Steps
Standard Deviation 2668.91
|
|
ActiGraph GT9X
Follow-Up
|
3050.62 Steps
Standard Deviation 2023.89
|
3290.56 Steps
Standard Deviation 2496.78
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
PROMIS Depression v1.08b
Baseline
|
54.67 score on a scale
Standard Deviation 9.48
|
54 score on a scale
Standard Deviation 9.54
|
|
PROMIS Depression v1.08b
Post-Test
|
52.81 score on a scale
Standard Deviation 8.53
|
52.14 score on a scale
Standard Deviation 9.49
|
|
PROMIS Depression v1.08b
Follow-Up
|
52.59 score on a scale
Standard Deviation 8.75
|
52.82 score on a scale
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
PROMIS Anxiety v1.08a
Baseline
|
57.25 score on a scale
Standard Deviation 10.49
|
56.24 score on a scale
Standard Deviation 10.14
|
|
PROMIS Anxiety v1.08a
Post-Test
|
55.04 score on a scale
Standard Deviation 9.84
|
54.69 score on a scale
Standard Deviation 9.08
|
|
PROMIS Anxiety v1.08a
Follow-Up
|
53.67 score on a scale
Standard Deviation 9.92
|
53.12 score on a scale
Standard Deviation 12.97
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Baseline
|
20.47 score on a scale
Standard Deviation 11.30
|
19.71 score on a scale
Standard Deviation 13.56
|
|
Pain Catastrophizing Scale (PCS)
Post-Test
|
11.70 score on a scale
Standard Deviation 9.60
|
16.77 score on a scale
Standard Deviation 13.81
|
|
Pain Catastrophizing Scale (PCS)
Follow-Up
|
12.57 score on a scale
Standard Deviation 8.86
|
16.20 score on a scale
Standard Deviation 13.63
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=39 Participants
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.
|
|---|---|---|
|
Tampa Kinesiophobia Scale (TSK)
Baseline
|
39.98 score on a scale
Standard Deviation 5.39
|
40.37 score on a scale
Standard Deviation 5.84
|
|
Tampa Kinesiophobia Scale (TSK)
Post-Test
|
34.88 score on a scale
Standard Deviation 6.86
|
40.13 score on a scale
Standard Deviation 5.70
|
|
Tampa Kinesiophobia Scale (TSK)
Follow-Up
|
34.94 score on a scale
Standard Deviation 6.00
|
39.20 score on a scale
Standard Deviation 7.52
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=44 Participants
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.
|
|---|---|---|
|
Measure of Current Status (MOCS)
Baseline
|
2.27 score on a scale
Standard Deviation 0.60
|
2.27 score on a scale
Standard Deviation 0.84
|
|
Measure of Current Status (MOCS)
Post-Test
|
2.50 score on a scale
Standard Deviation 0.68
|
2.37 score on a scale
Standard Deviation 0.79
|
|
Measure of Current Status (MOCS)
Follow-Up
|
2.51 score on a scale
Standard Deviation 0.74
|
2.57 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)Population: The number of participants who completed post-test and follow-up surveys was fewer than baselines because of patients discontinuing participation.
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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=47 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=45 Participants
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.
|
|---|---|---|
|
Cognitive and Affective Mindfulness Scale (CAMS)
Baseline
|
32.11 score on a scale
Standard Deviation 5.68
|
34.43 score on a scale
Standard Deviation 7.98
|
|
Cognitive and Affective Mindfulness Scale (CAMS)
Post-Test
|
34.33 score on a scale
Standard Deviation 5.97
|
34.32 score on a scale
Standard Deviation 7.52
|
|
Cognitive and Affective Mindfulness Scale (CAMS)
Follow-Up
|
32.96 score on a scale
Standard Deviation 6.42
|
35.46 score on a scale
Standard Deviation 6.88
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants (GetActive Fitbit and Healthy Living for Pain)
n=44 Participants
Includes all individuals who were eligible to participate (adult with chronic musculoskeletal pain) across all three sites.
|
Healthy Living for Pain
n=40 Participants
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.
|
|---|---|---|
|
Modified Global Impression of Change (MGIC)
Global Impressions of Change: Pain Management
|
6.20 score on a scale
Standard Deviation 0.70
|
5.38 score on a scale
Standard Deviation 1.23
|
|
Modified Global Impression of Change (MGIC)
Global Impressions of Change: Physical Function
|
5.93 score on a scale
Standard Deviation 0.87
|
5.15 score on a scale
Standard Deviation 1.29
|
|
Modified Global Impression of Change (MGIC)
Global Impressions of Change: Emotional Wellbeing
|
6.00 score on a scale
Standard Deviation 0.75
|
5.40 score on a scale
Standard Deviation 1.32
|
Adverse Events
GetActive-Fitbit
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Healthy Living for Pain
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GetActive-Fitbit
n=47 participants at risk
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.
|
Healthy Living for Pain
n=45 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Hospitalization for neurological symptoms
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
Vascular disorders
Cerebrovascular accident
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
Surgical and medical procedures
Hospitalization for lumbar surgery
|
0.00%
0/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
General disorders
Hospitalization after emergency room visit
|
0.00%
0/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
Psychiatric disorders
Active Suicidality
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
Blood and lymphatic system disorders
Hospitalization for high blood pressure
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
Renal and urinary disorders
Kidney Transplant
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
Blood and lymphatic system disorders
Hospitalization for blood clot
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
General disorders
Hospitalization for migraine
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
Other adverse events
| Measure |
GetActive-Fitbit
n=47 participants at risk
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.
|
Healthy Living for Pain
n=45 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.1%
1/47 • 9 months
|
4.4%
2/45 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Emergency room visit for pain
|
6.4%
3/47 • Number of events 4 • 9 months
|
4.4%
2/45 • 9 months
|
|
Renal and urinary disorders
Emergency room visit for urinary tract infection
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain/injury
|
10.6%
5/47 • 9 months
|
4.4%
2/45 • 9 months
|
|
Renal and urinary disorders
Kidney injury or infection
|
2.1%
1/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
Injury, poisoning and procedural complications
Adverse reaction to medical procedure
|
2.1%
1/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Toxic Multinodular Goiter
|
2.1%
1/47 • 9 months
|
0.00%
0/45 • 9 months
|
|
Psychiatric disorders
Distress related to intervention homework
|
0.00%
0/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
Immune system disorders
Autoimmune disease diagnosis
|
0.00%
0/47 • 9 months
|
4.4%
2/45 • 9 months
|
|
Psychiatric disorders
Passive death ideation
|
0.00%
0/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
General disorders
Motor vehicle collision
|
0.00%
0/47 • 9 months
|
4.4%
2/45 • 9 months
|
|
Gastrointestinal disorders
Severe rectal bleeding
|
0.00%
0/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
Psychiatric disorders
Partial psychiatric hospitalization
|
0.00%
0/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
General disorders
Fall
|
0.00%
0/47 • 9 months
|
2.2%
1/45 • 9 months
|
|
Surgical and medical procedures
Outpatient procedure
|
0.00%
0/47 • 9 months
|
4.4%
2/45 • 9 months
|
Additional Information
Ana-Maria Vranceanu, PhD
Massachusetts General Hospital
Phone: 617-724-4977
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place