Trial Outcomes & Findings for Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain (NCT NCT03412916)
NCT ID: NCT03412916
Last Updated: 2025-10-14
Results Overview
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Post-Test (10 Weeks)
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
GetActive
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain
Baseline characteristics by cohort
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
54.46 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
49.07 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
51.77 years
STANDARD_DEVIATION 14.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital status
Single, never married
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Marital status
Living with significant other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Marital status
Married
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Marital status
Separated/divorced
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Marital status
Widowed
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
High school (12 years)
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Some college/associate degree (<16 years)
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Education
Completed college (16 years)
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education
Graduate/professional degree (>16 years)
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-Test (10 Weeks)Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Outcome measures
| Measure |
GetActive
n=34 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=36 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint
Scored above the scale midpoint
|
34 Participants
|
35 Participants
|
|
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint
Scored below the scale midpoint
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Collected during the interventionTwo independent coders rated whether clinicians delivered each component of study sessions (e.g., deep breathing, providing education on prevalent myths about chronic pain) , exhibited skillful delivery (e.g., active listening, validation), and followed study protocol (e.g., collecting home practice sheets, logging attendance). Each individual component was rated on a yes/no scale. The adherent ("yes") components were summed, tallied against the total number of components in the adherence checklist, and averaged between the 2 reviewers. The score represents a total rate of adherence.
Outcome measures
| Measure |
GetActive
n=391 Components
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=347 Components
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Therapist Adherence
|
94 percentage of adherence
|
98 percentage of adherence
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks)Population: The number of participants who received an ActiGraph at post-tests was fewer than baselines because of patients discontinuing participation.
Rate of participant's use of ActiGraph watch for a period of one week at both baseline and post-treatment assessments. A valid day of wear consisted of at least 7 hours of wear time.
Outcome measures
| Measure |
GetActive
n=33 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=39 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
Baseline · Who received the ActiGraph and wore it for ≥ 5 out of 7 days
|
31 Participants
|
36 Participants
|
|
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
Baseline · Who received the ActiGraph and wore it for < 5 out of 7 days
|
2 Participants
|
3 Participants
|
|
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
Post-Test · Who received the ActiGraph and wore it for ≥ 5 out of 7 days
|
25 Participants
|
29 Participants
|
|
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
Post-Test · Who received the ActiGraph and wore it for < 5 out of 7 days
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks)Any self-reported or observed negative events related to participation.
Outcome measures
| Measure |
GetActive
n=35 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=37 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Program Safety - Number of Adverse Events Related to Study Participation
|
0 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks)Rate of participant's completion of homework assigned throughout the study. Logs were considered adherent if participants completed 3 home practice components 3 out of 7 days per week or 1 home practice component 5 out of 7 days per week.
Outcome measures
| Measure |
GetActive
n=35 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=37 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria
participants that completed logs handed in met adherence criteria
|
34 Participants
|
36 Participants
|
|
Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria
participants that completed logs handed in that did not meet adherence criteria
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks)The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Feasibility of Quantitative Measures
|
41 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks)Number of participants who score above the midpoint on two subscales assessed using frequencies and proportions. The measure involves two subscales: credibility (questions 1-3) and expectancy (questions 4-6). Subscale scores range from 3 to 27. Higher scores indicate greater perceived credibility and greater belief that treatment will help.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Credibility and Expectancy Questionnaire (CEQ)
Expectancy · scored above the scale midpoint
|
27 Participants
|
22 Participants
|
|
Credibility and Expectancy Questionnaire (CEQ)
Expectancy · scored below the scale midpoint
|
14 Participants
|
19 Participants
|
|
Credibility and Expectancy Questionnaire (CEQ)
Credibility · scored above the scale midpoint
|
37 Participants
|
38 Participants
|
|
Credibility and Expectancy Questionnaire (CEQ)
Credibility · scored below the scale midpoint
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Post-Test (10 Weeks)Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Program Acceptability
Attended ≥7 out of 10 group or make-up sessions
|
31 Participants
|
34 Participants
|
|
Program Acceptability
Attended <7 out of 10 group or make-up sessions
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
6-Min Walk Test Distance
Baseline
|
346.244 Meters
Standard Error 13.684
|
331.866 Meters
Standard Error 13.898
|
|
6-Min Walk Test Distance
Posttest
|
389.492 Meters
Standard Error 12.950
|
385.872 Meters
Standard Error 12.691
|
SECONDARY outcome
Timeframe: 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
Average steps counted for using the wGT3X-BT ActiGraph accelerometer device. Daily step counts were collected using the device for a week at each assessment period. A weekly average was calculated from the daily totals.
Outcome measures
| Measure |
GetActive
n=31 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=37 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
ActiGraph Average Steps
Baseline
|
5621.095674 Steps
Standard Error 595.369
|
5226.732 Steps
Standard Error 409.875
|
|
ActiGraph Average Steps
Posttest
|
5606.226 Steps
Standard Error 600.898
|
5271.760 Steps
Standard Error 391.723
|
SECONDARY outcome
Timeframe: Post-Test (10 Weeks)The PGIC assesses clinically important change in symptoms since beginning treatment. Each of the 6 items assesses a different treatment target. Items are assessed on a scale of 0 to 6. Lower scores indicate greater symptom improvement.
Outcome measures
| Measure |
GetActive
n=35 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=37 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
Impression of change in pain
|
2.51 score on a scale
Standard Deviation 1.17
|
2.70 score on a scale
Standard Deviation 1.20
|
|
Patient Global Impression of Change (PGIC)
Impression of change in physical activity
|
2.31 score on a scale
Standard Deviation 1.18
|
2.30 score on a scale
Standard Deviation 1.10
|
|
Patient Global Impression of Change (PGIC)
Impression of change in physical function
|
2.57 score on a scale
Standard Deviation 1.19
|
2.78 score on a scale
Standard Deviation 0.95
|
|
Patient Global Impression of Change (PGIC)
Impression of change in emotional function
|
2.40 score on a scale
Standard Deviation 1.01
|
2.54 score on a scale
Standard Deviation 0.84
|
|
Patient Global Impression of Change (PGIC)
Impression of change in resiliency
|
2.14 score on a scale
Standard Deviation 0.91
|
2.32 score on a scale
Standard Deviation 1.03
|
|
Patient Global Impression of Change (PGIC)
Impression of change from use of Fitbit
|
NA score on a scale
Standard Deviation NA
|
1.86 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The PASIPD is a 13-item measure that assesses one's level of physical activity and exercise in the past 7 days. Scores range from 0 to 100. Higher scores indicate greater activity.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Physical Activity Scale for Persons With Physical Disabilities (PASIPD)
Baseline
|
9.200 score on a scale
Standard Error 1.073
|
14.213 score on a scale
Standard Error 2.819
|
|
Physical Activity Scale for Persons With Physical Disabilities (PASIPD)
Posttest
|
10.985 score on a scale
Standard Error 1.422
|
16.742 score on a scale
Standard Error 2.421
|
|
Physical Activity Scale for Persons With Physical Disabilities (PASIPD)
Follow up
|
9.097 score on a scale
Standard Error 1.280
|
13.396 score on a scale
Standard Error 1.791
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100. Higher scores indicate more disability.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
WHO Disability Assessment Schedule 2.0 (WHODAS)
Baseline
|
26.91 score on a scale
Standard Error 2.51
|
36.64 score on a scale
Standard Error 3.28
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS)
Posttest
|
18.56 score on a scale
Standard Error 2.28
|
27.88 score on a scale
Standard Error 2.71
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS)
Follow-up
|
20.88 score on a scale
Standard Error 3.17
|
27.42 score on a scale
Standard Error 3.38
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The 8-item scale assesses for how difficult it is for one to perform daily living activities. Raw scores range from 8 to 40. T scores range from 20.3 to 60.1. Higher scores indicate better physical function and ability to perform activities of daily living.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Physical Function v.8b
Baseline
|
39.74 score on a scale
Standard Error 1.05
|
37.29 score on a scale
Standard Error 1.26
|
|
Patient-Reported Outcomes Measurement Information System Physical Function v.8b
Posttest
|
42.27 score on a scale
Standard Error 1.21
|
40.18 score on a scale
Standard Error 1.37
|
|
Patient-Reported Outcomes Measurement Information System Physical Function v.8b
Follow-up
|
44.70 score on a scale
Standard Error 1.35
|
41.30 score on a scale
Standard Error 1.65
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The 8-item scale measures fear and worry over the past week. Raw scores range from 8 to 40. T-scores range from 37.1 to 83.1. Higher scores indicate higher levels of anxiety.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Anxiety v.8a
Baseline
|
53.50 score on a scale
Standard Deviation 1.58
|
59.33 score on a scale
Standard Deviation 1.39
|
|
Patient-Reported Outcomes Measurement Information System Anxiety v.8a
Posttest
|
51.26 score on a scale
Standard Deviation 1.41
|
56.39 score on a scale
Standard Deviation 1.53
|
|
Patient-Reported Outcomes Measurement Information System Anxiety v.8a
Follow-up
|
51.49 score on a scale
Standard Deviation 1.68
|
57.27 score on a scale
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The 8-item scale measures depressive symptoms over the past week. Raw scores range from 8 to 40 and t scores range from 37.1 to 82.4. Higher scores indicate greater depressive symptoms.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Depression v.8b
Baseline
|
53.14 score on a scale
Standard Error 1.69
|
60.02 score on a scale
Standard Error 1.45
|
|
Patient-Reported Outcomes Measurement Information System Depression v.8b
Posttest
|
50.21 score on a scale
Standard Error 1.55
|
55.74 score on a scale
Standard Error 1.21
|
|
Patient-Reported Outcomes Measurement Information System Depression v.8b
Follow-up
|
50.21 score on a scale
Standard Error 1.54
|
55.75 score on a scale
Standard Error 1.70
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain. Scores range from 0 to 56. Higher scores indicate greater resilience.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Pain Resilience Scale (PRS)
Baseline Pain resilience
|
37.68 score on a scale
Standard Error 1.47
|
32.51 score on a scale
Standard Error 1.58
|
|
Pain Resilience Scale (PRS)
Posttest Pain resilience
|
43.55 score on a scale
Standard Error 1.64
|
36.19 score on a scale
Standard Error 1.82
|
|
Pain Resilience Scale (PRS)
3-Month follow- up Pain resilience
|
45.02 score on a scale
Standard Error 1.39
|
36.13 score on a scale
Standard Error 2.07
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Numerical Rating Scale
Baseline Pain at rest
|
5.07 score on a scale
Standard Error 0.39
|
5.70 score on a scale
Standard Error 0.34
|
|
Numerical Rating Scale
Posttest Pain at rest
|
3.73 score on a scale
Standard Error 0.41
|
4.58 score on a scale
Standard Error 0.36
|
|
Numerical Rating Scale
Follow up Pain at rest
|
4.18 score on a scale
Standard Error 0.41
|
4.30 score on a scale
Standard Error 0.50
|
|
Numerical Rating Scale
Baseline Pain during activity
|
6.93 score on a scale
Standard Error 0.31
|
7.15 score on a scale
Standard Error 0.34
|
|
Numerical Rating Scale
Posttest Pain during activity
|
5.16 score on a scale
Standard Error 0.42
|
6.01 score on a scale
Standard Error 0.41
|
|
Numerical Rating Scale
Follow-up Pain during activity
|
5.28 score on a scale
Standard Error 0.45
|
5.31 score on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings. Items range from 1 to 4. Total scores range from 12 to 48. Higher values reflect higher levels of mindfulness.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Cognitive and Affective Mindfulness Scale (CAMS)
Baseline Mindfulness
|
32.12 score on a scale
Standard Error 0.99
|
30.29 score on a scale
Standard Error 1.11
|
|
Cognitive and Affective Mindfulness Scale (CAMS)
Posttest Mindfulness
|
36.09 score on a scale
Standard Error 1.07
|
33.07 score on a scale
Standard Error 1.00
|
|
Cognitive and Affective Mindfulness Scale (CAMS)
Three-Month follow-up Mindfulness
|
35.95 score on a scale
Standard Error 1.09
|
34.08 score on a scale
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
8.756 score on a scale
Standard Error .664
|
11.293 score on a scale
Standard Error .629
|
|
Pittsburgh Sleep Quality Index (PSQI)
Post-test
|
6.979 score on a scale
Standard Error .622
|
10.754 score on a scale
Standard Error .686
|
|
Pittsburgh Sleep Quality Index (PSQI)
Follow up
|
6.565 score on a scale
Standard Error .558
|
10.046 score on a scale
Standard Error .737
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The 4-item scale measures how often one perceives feeling apart from others and excluded. Raw scores range from 4 to 20. Scaled scores range from 34.8 to 74.2. Higher scores indicate greater social isolation.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Social Isolation v.4a
Baseline
|
48.788 score on a scale
Standard Error 1.743
|
51.880 score on a scale
Standard Error 1.538
|
|
Patient-Reported Outcomes Measurement Information System Social Isolation v.4a
Post-test
|
45.364 score on a scale
Standard Error 1.556
|
49.793 score on a scale
Standard Error 1.629
|
|
Patient-Reported Outcomes Measurement Information System Social Isolation v.4a
Follow-up
|
47.582 score on a scale
Standard Error 1.673
|
51.252 score on a scale
Standard Error 1.916
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The 4-item scale measures perceived emotional support. Raw scores range from 4 to 20. Scaled scores range from 25.7 to 62. Higher score indicate greater emotional support.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Emotional Support v.4a
Baseline
|
49.924 score on a scale
Standard Error 1.365
|
48.432 score on a scale
Standard Error 1.288
|
|
Patient-Reported Outcomes Measurement Information System Emotional Support v.4a
Post-test
|
53.078 score on a scale
Standard Error 1.604
|
50.330 score on a scale
Standard Error 1.560
|
|
Patient-Reported Outcomes Measurement Information System Emotional Support v.4a
Follow-up
|
53.425 score on a scale
Standard Error 1.417
|
52.311 score on a scale
Standard Error 1.845
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. Total scores range from 0 to 52. A higher score indicates more catastrophizing.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Baseline
|
19.71 score on a scale
Standard Error 1.84
|
22.27 score on a scale
Standard Error 1.89
|
|
Pain Catastrophizing Scale (PCS)
Posttest
|
9.98 score on a scale
Standard Error 1.29
|
16.75 score on a scale
Standard Error 1.77
|
|
Pain Catastrophizing Scale (PCS)
Three-Month follow-up
|
9.91 score on a scale
Standard Error 1.49
|
16.79 score on a scale
Standard Error 2.03
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The TKS is a 17-item scale that measures one's fear of movement, with a greater score indicating greater fear of injury due to movement. Scores range from 11 to 44.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Tampa Kinesiophobia Scale (TKS)
Baseline
|
38.65 score on a scale
Standard Error 1.32
|
39.54 score on a scale
Standard Error 1.38
|
|
Tampa Kinesiophobia Scale (TKS)
Posttest
|
31.42 score on a scale
Standard Error 1.27
|
35.22 score on a scale
Standard Error 1.32
|
|
Tampa Kinesiophobia Scale (TKS)
3-Month follow- up
|
35.82 score on a scale
Standard Error 1.46
|
35.92 score on a scale
Standard Error 1.45
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
The MOCS-A, a 13-item scale, measures one's perceived ability to perform various skills that the intervention aims to target. Scores range from 0 to 52. Higher scores indicate greater perceived ability.
Outcome measures
| Measure |
GetActive
n=41 Participants
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=41 Participants
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Measure of Current Status (MOCS-A)
Baseline Adaptive Coping
|
27.56 score on a scale
Standard Error 1.49
|
27.27 score on a scale
Standard Error 1.50
|
|
Measure of Current Status (MOCS-A)
Posttest Adaptive Coping
|
36.09 score on a scale
Standard Error 1.43
|
34.10 score on a scale
Standard Error 1.33
|
|
Measure of Current Status (MOCS-A)
Three-Month follow-up Adaptive Coping
|
34.24 score on a scale
Standard Error 1.50
|
31.98 score on a scale
Standard Error 1.36
|
Adverse Events
GetActive
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
GetActive With Fitbit
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GetActive
n=35 participants at risk
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=37 participants at risk
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Vascular disorders
Stroke
|
2.9%
1/35 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/35 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
Other adverse events
| Measure |
GetActive
n=35 participants at risk
The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal \& coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.
GetActive: GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
|
GetActive With Fitbit
n=37 participants at risk
The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.
Get Active with Fitbit: The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
|
|---|---|---|
|
Nervous system disorders
Sciatica
|
2.9%
1/35 • Number of events 1 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Sprained quadricep muscle
|
0.00%
0/35 • 10 weeks
|
2.7%
1/37 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
2.9%
1/35 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain Flare
|
2.9%
1/35 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
|
Blood and lymphatic system disorders
Sickle Cell Anemia Flare
|
0.00%
0/35 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/35 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
|
Surgical and medical procedures
Chemotherapy
|
0.00%
0/35 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
|
General disorders
Hospitalization
|
0.00%
0/35 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
|
Cardiac disorders
Elevated blood pressure and heart rate
|
0.00%
0/35 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
Additional Information
Ana-Maria Vranceanu
Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital
Phone: (617) 724-3953
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place