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



Status:Recruiting
Conditions:Chronic Pain, Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:8/12/2018
Start Date:October 1, 2017
End Date:March 29, 2019
Contact:Ana-Maria Vranceanu, PhD
Email:avranceanu@mgh.harvard.edu
Phone:6176437996

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Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Orthopaedic Patients With Heterogeneous 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.

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.

Inclusion Criteria:

- Male and female patients, age 18 years or older

- Have nonmalignant chronic musculoskeletal pain for more than 3 months

- Able to perform a 6-minute walk test

- Owns a smart phone with Bluetooth 4.0 or computer

- Willingness and ability to participate in the 3RP-DMD 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 or in a wheelchair
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-7996
?
mi
from
Boston, MA
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