Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental GetActive |
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. |
|
|
Experimental GetActive with Fitbit |
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. |
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More Details
- Status
- Unknown status
- Sponsor
- Massachusetts General Hospital
Study Contact
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.