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

NCT03412916 | Completed Results DMC

• 1 other identifier: 2017P000628
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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 Fitbit.

Conditions

Pain; Chronic Pain; Physical Activity

Keywords

Chronic Pain; Physical Activity; Mind-body

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline (0 Weeks)

• Program Acceptability

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

  Post-Test (10 Weeks)

Secondary Outcomes (17)

• 6-Min Walk Test Distance

  6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).

• ActiGraph Average Steps

  1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks)

• Patient Global Impression of Change (PGIC)

  Post-Test (10 Weeks)

• Physical Activity Scale for Persons With Physical Disabilities (PASIPD)

  Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)

• WHO Disability Assessment Schedule 2.0 (WHODAS)

  Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)

Study Arms (2)

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.

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.

Behavioral: Get Active with Fitbit

Interventions

GetActive BEHAVIORAL

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

GetActive

Get Active with Fitbit BEHAVIORAL

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

GetActive with Fitbit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

• 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.

  PMID: 35231185 DERIVED

• Greenberg 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.

  PMID: 33649888 DERIVED

• Greenberg 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.

  PMID: 33574699 DERIVED

• Bannon 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.

  PMID: 33540223 DERIVED

• Greenberg 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.

  PMID: 33469845 DERIVED

• Greenberg 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.

  PMID: 32982388 DERIVED

• Greenberg 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.

  PMID: 32348281 DERIVED

MeSH Terms

Conditions

Pain; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Ana-Maria Vranceanu
• Organization: Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital

avranceanu@mgh.harvard.edu

(617) 724-3953

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 29, 2018
• Study Start: October 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)