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

CompletedNot applicableNCT03412916
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
Interventions
  • Behavioral: GetActive
  • Behavioral: Get Active with Fitbit
Sponsor
Massachusetts General Hospital
Start date
2017-10-01
Primary completion
2020-06-30
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03412916