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

Not Applicable

Completed

Conditions: Pain
Chronic Pain
Physical Activity

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: COMPLETED

Sex: All

Target Recruitment: 82

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint	Post-Test (10 Weeks)	Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Therapist Adherence	Collected during the intervention	Two independent coders rated whether clinicians delivered each component of study sessions (e.g., deep breathing, providing education on prevalent myths about chronic pain) , exhibited skillful delivery (e.g., active listening, validation), and followed study protocol (e.g., collecting home practice sheets, logging attendance). Each individual component was rated on a yes/no scale. The adherent ("yes") components were summed, tallied against the total number of components in the adherence checklist, and averaged between the 2 reviewers. The score represents a total rate of adherence.
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days	Baseline (0 Weeks), Post-Test (10 Weeks)	Rate of participant's use of ActiGraph watch for a period of one week at both baseline and post-treatment assessments. A valid day of wear consisted of at least 7 hours of wear time.
Program Safety - Number of Adverse Events Related to Study Participation	Baseline (0 Weeks), Post-Test (10 Weeks)	Any self-reported or observed negative events related to participation.
Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria	Baseline (0 Weeks), Post-Test (10 Weeks)	Rate of participant's completion of homework assigned throughout the study. Logs were considered adherent if participants completed 3 home practice components 3 out of 7 days per week or 1 home practice component 5 out of 7 days per week.
Feasibility of Quantitative Measures	Baseline (0 Weeks), Post-Test (10 Weeks)	The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments.
Credibility and Expectancy Questionnaire (CEQ)	Baseline (0 Weeks)	Number of participants who score above the midpoint on two subscales assessed using frequencies and proportions. The measure involves two subscales: credibility (questions 1-3) and expectancy (questions 4-6). Subscale scores range from 3 to 27. Higher scores indicate greater perceived credibility and greater belief that treatment will help.
Program Acceptability	Post-Test (10 Weeks)	Assessed via the percentage of participants who attended at least 7 out of 10 sessions.

Secondary Outcome Measures

Name	Time	Method
6-Min Walk Test Distance	6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).	Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes.
ActiGraph Average Steps	1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks)	Average steps counted for using the wGT3X-BT ActiGraph accelerometer device. Daily step counts were collected using the device for a week at each assessment period. A weekly average was calculated from the daily totals.
Patient Global Impression of Change (PGIC)	Post-Test (10 Weeks)	The PGIC assesses clinically important change in symptoms since beginning treatment. Each of the 6 items assesses a different treatment target. Items are assessed on a scale of 0 to 6. Lower scores indicate greater symptom improvement.
Physical Activity Scale for Persons With Physical Disabilities (PASIPD)	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)	The PASIPD is a 13-item measure that assesses one's level of physical activity and exercise in the past 7 days. Scores range from 0 to 100. Higher scores indicate greater activity.
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. Scores range from 0 to 100. Higher scores indicate more disability.
Patient-Reported Outcomes Measurement Information System 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. Raw scores range from 8 to 40. T scores range from 20.3 to 60.1. Higher scores indicate better physical function and ability to perform activities of daily living.
Patient-Reported Outcomes Measurement Information System 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. Raw scores range from 8 to 40. T-scores range from 37.1 to 83.1. Higher scores indicate higher levels of anxiety.
Patient-Reported Outcomes Measurement Information System 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. Raw scores range from 8 to 40 and t scores range from 37.1 to 82.4. Higher scores indicate greater depressive symptoms.
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. Scores range from 0 to 56. Higher scores indicate greater resilience.
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
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. Items range from 1 to 4. Total scores range from 12 to 48. Higher values reflect higher levels of mindfulness.
Pittsburgh Sleep Quality Index (PSQI)	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)	Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality.
Patient-Reported Outcomes Measurement Information System 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. Raw scores range from 4 to 20. Scaled scores range from 34.8 to 74.2. Higher scores indicate greater social isolation.
Patient-Reported Outcomes Measurement Information System Emotional Support v.4a	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)	The 4-item scale measures perceived emotional support. Raw scores range from 4 to 20. Scaled scores range from 25.7 to 62. Higher score indicate greater emotional support.
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. Total scores range from 0 to 52. 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 of injury due to movement. Scores range from 11 to 44.
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. Scores range from 0 to 52. Higher scores indicate greater perceived ability.

Trial Locations

Locations (1): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States