PainNCT03412916
Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain
A study testing GetActive and Get Active with Fitbit in people with Pain and Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Physical Activity
- What is being tested?
- GetActive and Get Active with Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, age 18 years or older
- Have nonmalignant chronic pain for more than 3 months
- Able to perform a 6-minute walk test
- Owns a smartphone with Bluetooth 4.0
- Willingness and ability to participate in the 3RP intervention and to comply with the requirements of the study protocol (including weekly sessions and DMD use)
- Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
- Cleared by a medical doctor for study participation
- Leads a sedentary lifestyle
Who cannot join
- Diagnosed with medical illness expected to worsen in the next 6 months
- Serious mental illness or instability for which hospitalization may be likely in the next 6 months
- Current suicidal ideation reported on self-report
- Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
- Current substance use disorder, within the past 6 months
- Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
Show all 9Show fewer
- Regular use of DMD in the last 3 months
- Engagement in regular intensive physical exercise for >30 minute daily
- Unable to walk without use of assistance (e.g., wheelchair, walker)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
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.
Read the detailed description
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.
- Conditions
- Pain, Chronic Pain, Physical Activity
- Being tested
- GetActive, Get Active with Fitbit
- Keywords
- Chronic Pain, Physical Activity, Mind-body
- Medical subject headings
- Pain, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetActiveBehavioural
Also called The Relaxation Response Resiliency Program for Pain
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.
Get Active with FitbitBehavioural
Also called The Relaxation Response Resiliency Program for Pain with DMD
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.
| Study group | Role | What they receive |
|---|---|---|
| GetActive | Experimental | 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. Receives: Behavioral: GetActive |
| GetActive with Fitbit | Experimental | 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. Receives: Behavioral: Get Active with Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (0 Weeks)
Program Acceptability
Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
Measured: Post-Test (10 Weeks)
Secondary outcomes (17)
6-Min Walk Test Distance
Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Oct 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412916
- Sponsor's protocol ID
- 2017P000628
- Status last verified
- Sep 2025
- First submitted
- 12 Jan 2018
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hopkins SW, Greenberg J, Isaacs J, Vranceanu AM. "Practice Makes Perfect"? Associations Between Home Practice and Physical and Emotional Function Outcomes Among Patients with Chronic Pain Enrolled in a Mind-Body Program. J Integr Complement Med. 2022 Apr;28(4):320-327. doi: 10.1089/jicm.2021.0324. Epub 2022 Feb 28.
PubMed 35231185Greenberg J, Singh T, Popok PJ, Kulich RJ, Vranceanu AM. Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain. Int J Behav Med. 2021 Dec;28(6):820-826. doi: 10.1007/s12529-021-09971-3. Epub 2021 Mar 2.
PubMed 33649888Greenberg J, Mace RA, Bannon SM, Kulich RJ, Vranceanu AM. Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function. J Pain Res. 2021 Feb 5;14:359-368. doi: 10.2147/JPR.S298212. eCollection 2021.
PubMed 33574699Bannon S, Greenberg J, Mace RA, Locascio JJ, Vranceanu AM. The role of social isolation in physical and emotional outcomes among patients with chronic pain. Gen Hosp Psychiatry. 2021 Mar-Apr;69:50-54. doi: 10.1016/j.genhosppsych.2021.01.009. Epub 2021 Jan 28.
PubMed 33540223Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19.
PubMed 33469845Greenberg J, Mace RA, Popok PJ, Kulich RJ, Patel KV, Burns JW, Somers TJ, Keefe FJ, Schatman ME, Vranceanu AM. Psychosocial Correlates of Objective, Performance-Based, and Patient-Reported Physical Function Among Patients with Heterogeneous Chronic Pain. J Pain Res. 2020 Sep 10;13:2255-2265. doi: 10.2147/JPR.S266455. eCollection 2020.
PubMed 32982388Greenberg J, Popok PJ, Lin A, Kulich RJ, James P, Macklin EA, Millstein RA, Edwards RR, Vranceanu AM. A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e18703. doi: 10.2196/18703.
PubMed 32348281
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
- ClinicalTrials.gov ID
- NCT03412916
- Acronym / sponsor ID
- 2017P000628
- Conditions
- Pain, Chronic Pain, Physical Activity
- Keywords
- Chronic Pain, Physical Activity, Mind-body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GetActive | Experimental | Behavioral: GetActiveThe 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 with Fitbit | Experimental | Behavioral: Get Active with FitbitThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients, age 18 years or older
- Have nonmalignant chronic pain for more than 3 months
- Able to perform a 6-minute walk test
- Owns a smartphone with Bluetooth 4.0
- Willingness and ability to participate in the 3RP intervention and to comply with the requirements of the study protocol (including weekly sessions and DMD use)
Key exclusion criteria (9 listed)
- Diagnosed with medical illness expected to worsen in the next 6 months
- Serious mental illness or instability for which hospitalization may be likely in the next 6 months
- Current suicidal ideation reported on self-report
- Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
- Current substance use disorder, within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GetActiveAlso: The Relaxation Response Resiliency Program for PainGetActive 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. | Behavioural | GetActive |
| Get Active with FitbitAlso: The Relaxation Response Resiliency Program for Pain with DMDThe 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. | Behavioural | GetActive with Fitbit |
Primary outcome
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint
Time frame: Post-Test (10 Weeks)
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Therapist Adherence
Time frame: Collected during the intervention
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.
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
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.
Program Safety - Number of Adverse Events Related to Study Participation
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
Any self-reported or observed negative events related to participation.
Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria
Time frame: 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.
Feasibility of Quantitative Measures
Time frame: 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.
Credibility and Expectancy Questionnaire (CEQ)
Time frame: 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.
Program Acceptability
Time frame: Post-Test (10 Weeks)
Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
17 secondary outcomes
6-Min Walk Test Distance
Time frame: 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).
ActiGraph Average Steps
Time frame: 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks)
Patient Global Impression of Change (PGIC)
Time frame: Post-Test (10 Weeks)
Physical Activity Scale for Persons With Physical Disabilities (PASIPD)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS)
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
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient-Reported Outcomes Measurement Information System Anxiety v.8a
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient-Reported Outcomes Measurement Information System Depression v.8b
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pain Resilience Scale (PRS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Numerical Rating Scale
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Cognitive and Affective Mindfulness Scale (CAMS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pittsburgh Sleep Quality Index (PSQI)
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
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
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Tampa Kinesiophobia Scale (TKS)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Measure of Current Status (MOCS-A)
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35231185Hopkins SW, Greenberg J, Isaacs J, Vranceanu AM. "Practice Makes Perfect"? Associations Between Home Practice and Physical and Emotional Function Outcomes Among Patients with Chronic Pain Enrolled in a Mind-Body Program. J Integr Complement Med. 2022 Apr;28(4):320-327. doi: 10.1089/jicm.2021.0324. Epub 2022 Feb 28.
- Derived from this study: PubMed 33649888Greenberg J, Singh T, Popok PJ, Kulich RJ, Vranceanu AM. Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain. Int J Behav Med. 2021 Dec;28(6):820-826. doi: 10.1007/s12529-021-09971-3. Epub 2021 Mar 2.
- Derived from this study: PubMed 33574699Greenberg J, Mace RA, Bannon SM, Kulich RJ, Vranceanu AM. Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function. J Pain Res. 2021 Feb 5;14:359-368. doi: 10.2147/JPR.S298212. eCollection 2021.
- Derived from this study: PubMed 33540223Bannon S, Greenberg J, Mace RA, Locascio JJ, Vranceanu AM. The role of social isolation in physical and emotional outcomes among patients with chronic pain. Gen Hosp Psychiatry. 2021 Mar-Apr;69:50-54. doi: 10.1016/j.genhosppsych.2021.01.009. Epub 2021 Jan 28.
- Derived from this study: PubMed 33469845Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19.
- Derived from this study: PubMed 32982388Greenberg J, Mace RA, Popok PJ, Kulich RJ, Patel KV, Burns JW, Somers TJ, Keefe FJ, Schatman ME, Vranceanu AM. Psychosocial Correlates of Objective, Performance-Based, and Patient-Reported Physical Function Among Patients with Heterogeneous Chronic Pain. J Pain Res. 2020 Sep 10;13:2255-2265. doi: 10.2147/JPR.S266455. eCollection 2020.
- Derived from this study: PubMed 32348281Greenberg J, Popok PJ, Lin A, Kulich RJ, James P, Macklin EA, Millstein RA, Edwards RR, Vranceanu AM. A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e18703. doi: 10.2196/18703.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GetActive and Get Active with Fitbit in people with Pain and Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint (time frame: Post-Test (10 Weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412916, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.