Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain
- Conditions
- PainChronic PainPhysical Activity
- Interventions
- Behavioral: GetActiveBehavioral: Get Active with Fitbit
- Registration Number
- NCT03412916
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GetActive 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. GetActive with Fitbit Get Active 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.
- Primary Outcome Measures
Name Time Method Change in Client Satisfaction Questionnaire 3-Item (CSQ-3) Post-Test (10 Weeks) Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
- Secondary Outcome Measures
Name Time Method Adherence to DMD Baseline (0 Weeks), Post-Test (10 Weeks) Rate of participant's use of DMD throughout the study
Adherence to Homework Baseline (0 Weeks), Post-Test (10 Weeks) Rate of participant's completion of homework assigned throughout the study
Therapist Adherence to Sessions Baseline (0 Weeks), Post-Test (10 Weeks) Rate of interventionist's delivering the programs by following the established session topics and skills
Feasibility of Quantitative Measures Baseline (0 Weeks), Post-Test (10 Weeks) Rate of participant's completion of self-report measures
Rescue (Non-Narcotic) Analgesic Use Baseline (0 Weeks), Post-Test (10 Weeks) Single-item question on demographics form
Narcotic Analgesic Use Baseline (0 Weeks), Post-Test (10 Weeks) Single-item question on demographics form
Adverse Events Baseline (0 Weeks), Post-Test (10 Weeks) any self reported or observed negative events related to participation
Credibility and Expectancy Questionnaire (CEQ) Baseline (0 Weeks) Measures how much one thinks the intervention will work
Pittsburgh Sleep Quality Index (PSQI) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) Measures one's sleep quality
PROMIS Physical Function v.8b Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The 8-item scale assesses for how difficult it is for one to perform daily living activities
Physical Activity Scale for Persons with Physical Disabilities (PASIPD) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The PASIPD measures one's level of physical activity and exercise in the past 7 days
Numerical Rating Scale Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever
WHO Disability Assessment Schedule 2.0 (WHODAS) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation
Pain Resilience Scale (PRS) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain
PROMIS Emotional Support v.4a Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The 4-item scale measures how often one feels valued and confidant has relationships
Cognitive and Affective Mindfulness Scale (CAMS) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings
PROMIS Depression v.8b Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The 8-item scale measures depressive symptoms over the past week
PROMIS Anxiety v.8a Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The 8-item scale measures fear and worry over the past week
PROMIS Social Isolation v.4a Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The 4-item scale measures how often one perceives feeling apart from others and excluded.
Pain Catastrophizing Scale (PCS) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. A higher score indicates more catastrophizing
Tampa Kinesiophobia Scale (TKS) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The TKS is a 17-item scale that measures one's fear of movement, with a greater score indicating greater fear
Measure of Current Status (MOCS-A) Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) The MOCS-A, a 13-item scale, measures one's perceived ability to perform various skills that the intervention aims to target
Patient Global Impression of Change (PGIC) Post-Test (10 Weeks) The PGIC assesses clinically important change from baseline to post-test
Post-Test Feasibility Questions Post-Test (10 Weeks) Assesses how helpful components of the intervention were
3-Month Follow Up Questions 3-Month Follow-Up (23 Weeks) Assesses for physical activity in the DMD group
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States