N/A
N=23
4-week Mindfulness Program for Adults With Chronic Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03495856 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Feasibility - Study Retention — 0.96 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Training For Chronic Pain (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Study Retention |
0.96 | — |
| PRIMARY Feasibility - Session Attendance |
0.77 | — |
| PRIMARY Credibility and Expectancy Questionnaire Scores |
6.4; 6.0; 6.4; 7.3; 7.6 | — |
| PRIMARY Acceptability - Intervention Satisfaction |
0; 0; 1; 1; 1; 7 | — |
| SECONDARY Pain Intensity Scores |
5.91; 5.14 | 0.05 |
| SECONDARY Pain Interference Scores |
63.76; 60.10 | 0.017 sig |
| SECONDARY Physical Functioning Scores |
38.17; 38.22 | 0.938 |
| SECONDARY Depression Short-Form 4a Scores |
56.82; 53.49 | 0.005 sig |
| SECONDARY Anxiety Short-Form 4a Scores |
59.06; 56.84 | 0.124 |
| SECONDARY Sleep Disturbance Short-Form 4a Scores |
56.52; 51.83 | 0.001 sig |
Summary
The objective of this study is to determine the feasibility and acceptability of a 4-week mindfulness training program for adults with chronic pain (noncancer related). The intervention is based on the MIndfulness-based Stress Reduction Program, an 8-week mindfulness training program developed to help people manage stress-related and chronic conditions. The adapted mindfulness intervention will consist of four, weekly 1 hour and 30 minute group sessions that are modified from the original program to fit the shorter length and to directly address chronic pain management. Participants will complete pre- and post-intervention surveys and daily mindfulness practice diaries, all online. The surveys will help us determine if participants experience decreased pain interference, increased quality-of-life, and increased psychological well-being over the course of the intervention. Participants will also complete a post-intervention telephone interview to help determine satisfaction with the intervention and areas where the intervention can be improved.
Eligibility Criteria
Inclusion Criteria
- One or more chronic noncancer pain diagnoses (daily pain for at least 3 months)
- Has a pain management provider
- Reports more than minimal pain bothersomeness and interference in general activities
- Able to read and understand English
Exclusion Criteria
- Diagnosis of mental illness with psychotic features
- History of inpatient admission for psychiatric disorder in past 2 years
- Active alcohol or substance abuse within the past year
- Has completed a mindfulness-based stress reduction or other mindfulness course; has or previously had a regular mindfulness meditation practice.
- Unable or unwilling to comply with study procedures (online questionnaires and practice diaries, 4 weekly intervention sessions, home practice, and one semi-structured phone interview).
Data sourced from ClinicalTrials.gov (NCT03495856). 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.