NCT03412916

Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain

Completed NA Results posted Last updated 14 October 2025

What this trial tests

NA trial testing GetActive in Pain in 82 participants. Completed in 30 June 2020.

Timeline

1 October 2017

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 October 2017
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• GetActive
• Get Active with Fitbit

Conditions studied

• Pain — all drugs for Pain →
• Chronic Pain — all drugs for Chronic Pain →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Pain or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint Primary · Post-Test (10 Weeks)

Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.

Scored above the scale midpoint

Group	Value	95% CI
GetActive	34
GetActive With Fitbit	35

Scored below the scale midpoint

Group	Value	95% CI
GetActive	0
GetActive With Fitbit	1

Therapist Adherence Primary · 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.

Group	Value	95% CI
GetActive With Fitbit	94
GetActive	98

Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days Primary · 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.

Baseline

Group	Value	95% CI
GetActive	31
GetActive With Fitbit	36
GetActive	2
GetActive With Fitbit	3

Post-Test

Group	Value	95% CI
GetActive	25
GetActive With Fitbit	29
GetActive	2
GetActive With Fitbit	4

Program Safety - Number of Adverse Events Related to Study Participation Primary · Baseline (0 Weeks), Post-Test (10 Weeks)

Any self-reported or observed negative events related to participation.

Group	Value	95% CI
GetActive	0
GetActive With Fitbit	0

Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria Primary · 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.

participants that completed logs handed in met adherence criteria

Group	Value	95% CI
GetActive	34
GetActive With Fitbit	36

participants that completed logs handed in that did not meet adherence criteria

Group	Value	95% CI
GetActive	1
GetActive With Fitbit	1

Feasibility of Quantitative Measures Primary · 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.

Group	Value	95% CI
GetActive	41
GetActive With Fitbit	40

Credibility and Expectancy Questionnaire (CEQ) Primary · 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.

Expectancy

Group	Value	95% CI
GetActive	27
GetActive With Fitbit	22
GetActive	14
GetActive With Fitbit	19

Credibility

Group	Value	95% CI
GetActive	37
GetActive With Fitbit	38
GetActive	4
GetActive With Fitbit	3

Program Acceptability Primary · Post-Test (10 Weeks)

Assessed via the percentage of participants who attended at least 7 out of 10 sessions.

Group	Value	95% CI
GetActive	31
GetActive With Fitbit	34
GetActive	10
GetActive With Fitbit	7

6-Min Walk Test Distance Secondary · 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).

Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes.

Baseline

Group	Value	95% CI
GetActive	346.244	± 13.684
GetActive With Fitbit	331.866	± 13.898

Posttest

Group	Value	95% CI
GetActive	389.492	± 12.950
GetActive With Fitbit	385.872	± 12.691

ActiGraph Average Steps Secondary · 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks)

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.

Baseline

Group	Value	95% CI
GetActive	5621.095674	± 595.369
GetActive With Fitbit	5226.732	± 409.875

Posttest

Group	Value	95% CI
GetActive	5606.226	± 600.898
GetActive With Fitbit	5271.760	± 391.723

Patient Global Impression of Change (PGIC) Secondary · 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.

Impression of change in pain

Group	Value	95% CI
GetActive	2.51	± 1.17
GetActive With Fitbit	2.70	± 1.20

Impression of change in physical activity

Group	Value	95% CI
GetActive	2.31	± 1.18
GetActive With Fitbit	2.30	± 1.10

Impression of change in physical function

Group	Value	95% CI
GetActive	2.57	± 1.19
GetActive With Fitbit	2.78	± 0.95

Impression of change in emotional function

Group	Value	95% CI
GetActive	2.40	± 1.01
GetActive With Fitbit	2.54	± 0.84

Impression of change in resiliency

Group	Value	95% CI
GetActive	2.14	± 0.91
GetActive With Fitbit	2.32	± 1.03

Impression of change from use of Fitbit

Group	Value	95% CI
GetActive	NA	± NA
GetActive With Fitbit	1.86	± 0.95

Physical Activity Scale for Persons With Physical Disabilities (PASIPD) Secondary · Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)

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.

Baseline

Group	Value	95% CI
GetActive	9.200	± 1.073
GetActive With Fitbit	14.213	± 2.819

Posttest

Group	Value	95% CI
GetActive	10.985	± 1.422
GetActive With Fitbit	16.742	± 2.421

Follow up

Group	Value	95% CI
GetActive	9.097	± 1.280
GetActive With Fitbit	13.396	± 1.791

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GetActive

Serious: 1/35 (3%)

Deaths: 0/35

GetActive With Fitbit

Serious: 1/37 (3%)

Deaths: 0/37

Serious adverse events (2 terms)

Reaction	System	GetActive	GetActive With Fitbit
Stroke	Vascular disorders	—	—
Fall	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	GetActive	GetActive With Fitbit
Sciatica	Nervous system disorders	—	—
Sprained quadricep muscle	Musculoskeletal and connective tissue disorders	—	—
Lung Infection	Respiratory, thoracic and mediastinal disorders	—	—
Pain Flare	Musculoskeletal and connective tissue disorders	—	—
Sickle Cell Anemia Flare	Blood and lymphatic system disorders	—	—
Diverticulitis	Gastrointestinal disorders	—	—
Chemotherapy	Surgical and medical procedures	—	—
Hospitalization	General disorders	—	—
Elevated blood pressure and heart rate	Cardiac disorders	—	—

Most-reported serious reactions: Stroke, Fall.

Data from ClinicalTrials.gov NCT03412916 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial.
   Greenberg J, Popok PJ, Lin A, Kulich RJ, et al · · 2020 · cited 53× · PMID 32348281 · DOI 10.2196/18703
2. The role of social isolation in physical and emotional outcomes among patients with chronic pain.
   Bannon S, Greenberg J, Mace RA, Locascio JJ, et al · · 2021 · cited 41× · PMID 33540223 · DOI 10.1016/j.genhosppsych.2021.01.009
3. Psychosocial Correlates of Objective, Performance-Based, and Patient-Reported Physical Function Among Patients with Heterogeneous Chronic Pain.
   Greenberg J, Mace RA, Popok PJ, Kulich RJ, et al · · 2020 · cited 23× · PMID 32982388 · DOI 10.2147/jpr.s266455
4. Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function.
   Greenberg J, Mace RA, Bannon SM, Kulich RJ, et al · · 2021 · cited 11× · PMID 33574699 · DOI 10.2147/jpr.s298212
5. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain.
   Greenberg J, Lin A, Popok PJ, Kulich RJ, et al · · 2021 · cited 4× · PMID 33469845 · DOI 10.1007/s10880-020-09758-w
6. Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain.
   Greenberg J, Singh T, Popok PJ, Kulich RJ, et al · · 2021 · cited 3× · PMID 33649888 · DOI 10.1007/s12529-021-09971-3
7. Effects of a Mind-Body Program for Chronic Pain in Older versus Younger Adults.
   LaRowe LR, Bakhshaie J, Vranceanu AM, Greenberg J. · · 2023 · cited 1× · PMID 38026460 · DOI 10.2147/jpr.s435639
8. Unraveling Chronic Pain: From Mechanisms and Risks to Diagnosis and Treatment.
   Dai X, Wang C, Jiang P, Mei X. · · 2026 · PMID 41930351 · DOI 10.1002/mco2.70685