N/A
Completed N=82
Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain
Postoperative Pain · Physical Activity
Source: ClinicalTrials.gov NCT03412916 ↗
Enrolled (actual)
82
Serious AEs
2.8%
Results posted
Oct 2025
Primary outcomePrimary: Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint — 34; 35; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint |
34; 35; 0; 1 | — |
| PRIMARY Therapist Adherence |
94; 98 | — |
| PRIMARY Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days |
31; 36; 2; 3; 25; 29 | — |
| PRIMARY Program Safety - Number of Adverse Events Related to Study Participation |
0; 0 | — |
| PRIMARY Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria |
34; 36; 1; 1 | — |
| PRIMARY Feasibility of Quantitative Measures |
41; 40 | — |
| PRIMARY Credibility and Expectancy Questionnaire (CEQ) |
27; 22; 14; 19; 37; 38 | — |
| PRIMARY Program Acceptability |
31; 34; 10; 7 | — |
| SECONDARY 6-Min Walk Test Distance |
346.244; 331.866; 389.492; 385.872 | — |
| SECONDARY ActiGraph Average Steps |
5621.095674; 5226.732; 5606.226; 5271.760 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
2.51; 2.70; 2.31; 2.30; 2.57; 2.78 | — |
| SECONDARY Physical Activity Scale for Persons With Physical Disabilities (PASIPD) |
9.200; 14.213; 10.985; 16.742; 9.097; 13.396 | — |
| SECONDARY WHO Disability Assessment Schedule 2.0 (WHODAS) |
26.91; 36.64; 18.56; 27.88; 20.88; 27.42 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System Physical Function v.8b |
39.74; 37.29; 42.27; 40.18; 44.70; 41.30 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System Anxiety v.8a |
53.50; 59.33; 51.26; 56.39; 51.49; 57.27 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System Depression v.8b |
53.14; 60.02; 50.21; 55.74; 50.21; 55.75 | — |
| SECONDARY Pain Resilience Scale (PRS) |
37.68; 32.51; 43.55; 36.19; 45.02; 36.13 | — |
| SECONDARY Numerical Rating Scale |
5.07; 5.70; 3.73; 4.58; 4.18; 4.30 | — |
| SECONDARY Cognitive and Affective Mindfulness Scale (CAMS) |
32.12; 30.29; 36.09; 33.07; 35.95; 34.08 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
8.756; 11.293; 6.979; 10.754; 6.565; 10.046 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System Social Isolation v.4a |
48.788; 51.880; 45.364; 49.793; 47.582; 51.252 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System Emotional Support v.4a |
49.924; 48.432; 53.078; 50.330; 53.425; 52.311 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
19.71; 22.27; 9.98; 16.75; 9.91; 16.79 | — |
| SECONDARY Tampa Kinesiophobia Scale (TKS) |
38.65; 39.54; 31.42; 35.22; 35.82; 35.92 | — |
| SECONDARY Measure of Current Status (MOCS-A) |
27.56; 27.27; 36.09; 34.10; 34.24; 31.98 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03412916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.