An interventional study of GetActive and Get Active with Fitbit in Pain, Chronic Pain and Physical Activity, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
Among 27 studies in Chronic Pain by Massachusetts General Hospital — 7 open to participants now, 8 under way, none of them phase 3. Chronic Pain · Massachusetts General Hospital.
Among the 27 studies in Chronic Pain by Massachusetts General Hospital, this one is the 8th largest by enrollment of the 23 interventional ones that give a count, is the only one that started in 2017, is one of 20 with no phase, and was the 9th registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
Browse Chronic Pain studies →7 of the 27 studies in Chronic Pain by Massachusetts General Hospital are open now, in 1 country. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in United States
Ages 50–120
Massachusetts General Hospital · Sites in United States
Ages 50+
Massachusetts General Hospital · Sites in United States
Ages 55+
Massachusetts General Hospital · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 82 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Median enrollment 60 across the 23 interventional studies, 65 across the 4 observational. Of the 18 that completed or were terminated, 10 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
5 of the studies in Chronic Pain by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07118722Massachusetts General HospitalMindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study | 2027-01-15 |
| NCT06119698Massachusetts General HospitalImproving Health for Older Adults With Pain Through Engagement | 2027-04-01 |
| NCT05661903Massachusetts General HospitalFrom Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects | 2027-08-31 |
| NCT07785648Massachusetts General HospitalMindfulness-Based Cognitive Therapy Vs. the Health Enhancement Program for Chronic Pain and Early Cognitive Decline; The Feeling of Being Pilot RCT | 2027-11-18 |
| NCT05684692Massachusetts General HospitalScreening Trial for Pain Relief in Schwannomatosis (STARFISH) | 2027-11-30 |
Among the 27 studies in Chronic Pain by Massachusetts General Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aims of this study are to adapt, pilot, and examine the credibility, acceptability, and feasibility of an evidence-based mind-body program, the Relaxation Response Resiliency Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is the p3RP integrated with a commercial DMD, the Fitbit.
The study has three phases. In phase I, the investigators are adapting the 3RP as a multidisciplinary team, and then conducting two focus groups. In phase two, the investigators are piloting the p3RP and p3RP-DMD. In phase three, the investigators are conducting a small randomized-controlled trial of the p3RP versus p3RP-DMD.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 82 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Compared within Chronic Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: GetActive
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.
Behavioral: Get Active with Fitbit
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.
Also known as: The Relaxation Response Resiliency Program for Pain
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.
Also known as: The Relaxation Response Resiliency Program for Pain with DMD
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Time frame: Post-Test (10 Weeks)
Therapist Adherence
Two 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.
Time frame: Collected during the intervention
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
Program Safety - Number of Adverse Events Related to Study Participation
Any self-reported or observed negative events related to participation.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
Feasibility of Quantitative Measures
The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
Credibility and Expectancy Questionnaire (CEQ)
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.
Time frame: Baseline (0 Weeks)
Program Acceptability
Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
Time frame: Post-Test (10 Weeks)
6-Min Walk Test Distance
Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes.
Time frame: 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).
ActiGraph Average Steps
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.
Time frame: 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks)
Patient Global Impression of Change (PGIC)
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.
Time frame: Post-Test (10 Weeks)
Physical Activity Scale for Persons With Physical Disabilities (PASIPD)
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS)
The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100. Higher scores indicate more disability.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient-Reported Outcomes Measurement Information System Physical Function v.8b
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient-Reported Outcomes Measurement Information System Anxiety v.8a
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient-Reported Outcomes Measurement Information System Depression v.8b
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pain Resilience Scale (PRS)
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Numerical Rating Scale
Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Cognitive and Affective Mindfulness Scale (CAMS)
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pittsburgh Sleep Quality Index (PSQI)
Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient-Reported Outcomes Measurement Information System Social Isolation v.4a
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient-Reported Outcomes Measurement Information System Emotional Support v.4a
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pain Catastrophizing Scale (PCS)
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Tampa Kinesiophobia Scale (TKS)
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Measure of Current Status (MOCS-A)
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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
| Milestone | GetActive | GetActive With Fitbit |
|---|---|---|
| Started | 41 | 41 |
| Completed | 35 | 37 |
| Not completed | 6 | 4 |
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
| Participants | GetActive | GetActive With Fitbit |
|---|---|---|
| Scored above the scale midpoint | 34 | 35 |
| Scored below the scale midpoint | 0 | 1 |
Two 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.
| percentage of adherence | GetActive With Fitbit | GetActive |
|---|---|---|
| Therapist Adherence | 94 | 98 |
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.
| Participants | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline — Who received the ActiGraph and wore it for ≥ 5 out of 7 days | 31 | 36 |
| Baseline — Who received the ActiGraph and wore it for < 5 out of 7 days | 2 | 3 |
| Post-Test — Who received the ActiGraph and wore it for ≥ 5 out of 7 days | 25 | 29 |
| Post-Test — Who received the ActiGraph and wore it for < 5 out of 7 days | 2 | 4 |
Any self-reported or observed negative events related to participation.
| adverse events | GetActive | GetActive With Fitbit |
|---|---|---|
| Program Safety - Number of Adverse Events Related to Study Participation | 0 | 0 |
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.
| Participants | GetActive | GetActive With Fitbit |
|---|---|---|
| participants that completed logs handed in met adherence criteria | 34 | 36 |
| participants that completed logs handed in that did not meet adherence criteria | 1 | 1 |
The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments.
| Participants | GetActive | GetActive With Fitbit |
|---|---|---|
| Feasibility of Quantitative Measures | 41 | 40 |
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.
| Participants | GetActive | GetActive With Fitbit |
|---|---|---|
| Expectancy — scored above the scale midpoint | 27 | 22 |
| Expectancy — scored below the scale midpoint | 14 | 19 |
| Credibility — scored above the scale midpoint | 37 | 38 |
| Credibility — scored below the scale midpoint | 4 | 3 |
Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
| Participants | GetActive | GetActive With Fitbit |
|---|---|---|
| Attended ≥7 out of 10 group or make-up sessions | 31 | 34 |
| Attended <7 out of 10 group or make-up sessions | 10 | 7 |
Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes.
| Meters | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 346.244 ± 13.684 | 331.866 ± 13.898 |
| Posttest | 389.492 ± 12.950 | 385.872 ± 12.691 |
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.
| Steps | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 5621.095674 ± 595.369 | 5226.732 ± 409.875 |
| Posttest | 5606.226 ± 600.898 | 5271.760 ± 391.723 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Impression of change in pain | 2.51 ± 1.17 | 2.70 ± 1.20 |
| Impression of change in physical activity | 2.31 ± 1.18 | 2.30 ± 1.10 |
| Impression of change in physical function | 2.57 ± 1.19 | 2.78 ± 0.95 |
| Impression of change in emotional function | 2.40 ± 1.01 | 2.54 ± 0.84 |
| Impression of change in resiliency | 2.14 ± 0.91 | 2.32 ± 1.03 |
| Impression of change from use of Fitbit | NA ± NA | 1.86 ± 0.95 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 9.200 ± 1.073 | 14.213 ± 2.819 |
| Posttest | 10.985 ± 1.422 | 16.742 ± 2.421 |
| Follow up | 9.097 ± 1.280 | 13.396 ± 1.791 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 26.91 ± 2.51 | 36.64 ± 3.28 |
| Posttest | 18.56 ± 2.28 | 27.88 ± 2.71 |
| Follow-up | 20.88 ± 3.17 | 27.42 ± 3.38 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 39.74 ± 1.05 | 37.29 ± 1.26 |
| Posttest | 42.27 ± 1.21 | 40.18 ± 1.37 |
| Follow-up | 44.70 ± 1.35 | 41.30 ± 1.65 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 53.50 ± 1.58 | 59.33 ± 1.39 |
| Posttest | 51.26 ± 1.41 | 56.39 ± 1.53 |
| Follow-up | 51.49 ± 1.68 | 57.27 ± 1.62 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 53.14 ± 1.69 | 60.02 ± 1.45 |
| Posttest | 50.21 ± 1.55 | 55.74 ± 1.21 |
| Follow-up | 50.21 ± 1.54 | 55.75 ± 1.70 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline Pain resilience | 37.68 ± 1.47 | 32.51 ± 1.58 |
| Posttest Pain resilience | 43.55 ± 1.64 | 36.19 ± 1.82 |
| 3-Month follow- up Pain resilience | 45.02 ± 1.39 | 36.13 ± 2.07 |
Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline Pain at rest | 5.07 ± 0.39 | 5.70 ± 0.34 |
| Posttest Pain at rest | 3.73 ± 0.41 | 4.58 ± 0.36 |
| Follow up Pain at rest | 4.18 ± 0.41 | 4.30 ± 0.50 |
| Baseline Pain during activity | 6.93 ± 0.31 | 7.15 ± 0.34 |
| Posttest Pain during activity | 5.16 ± 0.42 | 6.01 ± 0.41 |
| Follow-up Pain during activity | 5.28 ± 0.45 | 5.31 ± 0.60 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline Mindfulness | 32.12 ± 0.99 | 30.29 ± 1.11 |
| Posttest Mindfulness | 36.09 ± 1.07 | 33.07 ± 1.00 |
| Three-Month follow-up Mindfulness | 35.95 ± 1.09 | 34.08 ± 1.36 |
Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 8.756 ± .664 | 11.293 ± .629 |
| Post-test | 6.979 ± .622 | 10.754 ± .686 |
| Follow up | 6.565 ± .558 | 10.046 ± .737 |
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.
| score on a scale | GetActive | GetActive-Fitbit |
|---|---|---|
| Baseline | 48.788 ± 1.743 | 51.880 ± 1.538 |
| Post-test | 45.364 ± 1.556 | 49.793 ± 1.629 |
| Follow-up | 47.582 ± 1.673 | 51.252 ± 1.916 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 49.924 ± 1.365 | 48.432 ± 1.288 |
| Post-test | 53.078 ± 1.604 | 50.330 ± 1.560 |
| Follow-up | 53.425 ± 1.417 | 52.311 ± 1.845 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 19.71 ± 1.84 | 22.27 ± 1.89 |
| Posttest | 9.98 ± 1.29 | 16.75 ± 1.77 |
| Three-Month follow-up | 9.91 ± 1.49 | 16.79 ± 2.03 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline | 38.65 ± 1.32 | 39.54 ± 1.38 |
| Posttest | 31.42 ± 1.27 | 35.22 ± 1.32 |
| 3-Month follow- up | 35.82 ± 1.46 | 35.92 ± 1.45 |
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.
| score on a scale | GetActive | GetActive With Fitbit |
|---|---|---|
| Baseline Adaptive Coping | 27.56 ± 1.49 | 27.27 ± 1.50 |
| Posttest Adaptive Coping | 36.09 ± 1.43 | 34.10 ± 1.33 |
| Three-Month follow-up Adaptive Coping | 34.24 ± 1.50 | 31.98 ± 1.36 |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GetActive | 0/35 (0%) | 1/35 (2.9%) | 3/35 (8.6%) |
| GetActive With Fitbit | 0/37 (0%) | 1/37 (2.7%) | 7/37 (18.9%) |
| Event | GetActive | GetActive With Fitbit |
|---|---|---|
| StrokeVascular disorders | 1/35 | 0/37 |
| FallMusculoskeletal and connective tissue disorders | 0/35 | 1/37 |
| Event | GetActive | GetActive With Fitbit |
|---|---|---|
| SciaticaNervous system disorders | 1/35 | 0/37 |
| Lung InfectionRespiratory, thoracic and mediastinal disorders | 1/35 | 0/37 |
| Pain FlareMusculoskeletal and connective tissue disorders | 1/35 | 1/37 |
| Sprained quadricep muscleMusculoskeletal and connective tissue disorders | 0/35 | 1/37 |
| Sickle Cell Anemia FlareBlood and lymphatic system disorders | 0/35 | 1/37 |
| DiverticulitisGastrointestinal disorders | 0/35 | 1/37 |
| ChemotherapySurgical and medical procedures | 0/35 | 1/37 |
| HospitalizationGeneral disorders | 0/35 | 1/37 |
| Elevated blood pressure and heart rateCardiac disorders | 0/35 | 1/37 |
| Age, Categorical(Participants) | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 34 | 66 |
| >=65 years | 9 | 7 | 16 |
| Age, Continuous(years) | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| Mean | 54.46 ± 14.5 | 49.07 ± 14.2 | 51.77 ± 14.53 |
| Sex: Female, Male(Participants) | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| Female | 23 | 31 | 54 |
| Male | 18 | 10 | 28 |
| Ethnicity (NIH/OMB)(Participants) | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 4 | 8 |
| Not Hispanic or Latino | 35 | 37 | 72 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 2 | 7 |
| White | 32 | 34 | 66 |
| More than one race | 1 | 3 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Marital status(Participants) | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| Single, never married | 13 | 15 | 28 |
| Living with significant other | 5 | 6 | 11 |
| Married | 15 | 8 | 23 |
| Separated/divorced | 5 | 11 | 16 |
| Widowed | 3 | 1 | 4 |
| Education(Participants) | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| High school (12 years) | 5 | 6 | 11 |
| Some college/associate degree (<16 years) | 15 | 11 | 26 |
| Completed college (16 years) | 9 | 8 | 17 |
| Graduate/professional degree (>16 years) | 12 | 16 | 28 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jun 2020, 32 months.
Results were first posted in Oct 2025, 5 years 3 months after primary completion.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 32 months is above that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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