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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Chronic Pain, Physical Activity

Intervention / Treatment
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* Behavioral: GetActive
* Behavioral: Get Active with Fitbit


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GetActive<br>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<br>* 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.<br>* Other names: The Relaxation Response Resiliency Program for Pain;|
| Experimental: GetActive with Fitbit<br>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<br>* 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.<br>* Other names: The Relaxation Response Resiliency Program for Pain with DMD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Client Satisfaction Questionnaire 3-Item (CSQ-3) | Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. | Post-Test (10 Weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to DMD | Rate of participant's use of DMD throughout the study | Baseline (0 Weeks), Post-Test (10 Weeks) | 
| Adherence to Homework | Rate of participant's completion of homework assigned throughout the study | Baseline (0 Weeks), Post-Test (10 Weeks) | 
| Therapist Adherence to Sessions | Rate of interventionist's delivering the programs by following the established session topics and skills | Baseline (0 Weeks), Post-Test (10 Weeks) | 
| Feasibility of Quantitative Measures | Rate of participant's completion of self-report measures | Baseline (0 Weeks), Post-Test (10 Weeks) | 
| Rescue (Non-Narcotic) Analgesic Use | Single-item question on demographics form | Baseline (0 Weeks), Post-Test (10 Weeks) | 
| Narcotic Analgesic Use | Single-item question on demographics form | Baseline (0 Weeks), Post-Test (10 Weeks) | 
| Adverse Events | any self reported or observed negative events related to participation | Baseline (0 Weeks), Post-Test (10 Weeks) | 
| Credibility and Expectancy Questionnaire (CEQ) | Measures how much one thinks the intervention will work | Baseline (0 Weeks) | 
| Pittsburgh Sleep Quality Index (PSQI) | Measures one's sleep quality | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| PROMIS Physical Function v.8b | The 8-item scale assesses for how difficult it is for one to perform daily living activities | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Physical Activity Scale for Persons with Physical Disabilities (PASIPD) | The PASIPD measures one's level of physical activity and exercise in the past 7 days | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| WHO Disability Assessment Schedule 2.0 (WHODAS) | The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Numerical Rating Scale | Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Pain Resilience Scale (PRS) | The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| PROMIS Depression v.8b | The 8-item scale measures depressive symptoms over the past week | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| PROMIS Anxiety v.8a | The 8-item scale measures fear and worry over the past week | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| PROMIS Social Isolation v.4a | The 4-item scale measures how often one perceives feeling apart from others and excluded. | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| PROMIS Emotional Support v.4a | The 4-item scale measures how often one feels valued and confidant has relationships | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Cognitive and Affective Mindfulness Scale (CAMS) | The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Pain Catastrophizing Scale (PCS) | The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. A higher score indicates more catastrophizing | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Tampa Kinesiophobia Scale (TKS) | The TKS is a 17-item scale that measures one's fear of movement, with a greater score indicating greater fear | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Measure of Current Status (MOCS-A) | The MOCS-A, a 13-item scale, measures one's perceived ability to perform various skills that the intervention aims to target | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | 
| Patient Global Impression of Change (PGIC) | The PGIC assesses clinically important change from baseline to post-test | Post-Test (10 Weeks) | 
| Post-Test Feasibility Questions | Assesses how helpful components of the intervention were | Post-Test (10 Weeks) | 
| 3-Month Follow Up Questions | Assesses for physical activity in the DMD group | 3-Month Follow-Up (23 Weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Physical Activity, Mind-body