4-week Mindfulness Program for Adults With Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Mindfulness Training For Chronic Pain
- Registration Number
- NCT03495856
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mindfulness Training For Chronic Pain Mindfulness Training For Chronic Pain The intervention is adapted from the mindfulness-based stress reduction program. The adapted mindfulness training program consists of four, weekly 90 minute group sessions that focus on education on chronic pain and mindfulness, instruction and in-class mindfulness skills practice, and group discussion.
- Primary Outcome Measures
Name Time Method Feasibility - Session Attendance 4 weeks (intervention weeks 1-4) Average sessions attended (proportion)
Feasibility - Study Retention 4 weeks Proportion of participants enrolled who completed the study
Acceptability - Intervention Satisfaction 4 weeks (within one week post-intervention) Question assessing participants satisfaction with the intervention
Credibility and Expectancy Questionnaire Scores Intervention week 2 Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 \[not at all\] to 10 \[very\]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy.
- Secondary Outcome Measures
Name Time Method Pain Intensity Scores Baseline and 4 weeks (pre to post-intervention) Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome.
Depression Short-Form 4a Scores Baseline and 4 weeks (pre to post-intervention) Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates less depression, a better outcome.
Pain Interference Scores Baseline and 4 weeks (pre to post-intervention) Pain Interference short-form 6b, Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates lower pain interference, or a better outcome.
Physical Functioning Scores Baseline and 4 weeks (pre to post-intervention) Physical functioning short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A higher score indicates higher physical functioning, or a better outcome.
Anxiety Short-Form 4a Scores Baseline and 4 weeks (pre to post-intervention) Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent lower anxiety, a better outcome.
Sleep Disturbance Short-Form 4a Scores Baseline and 4 weeks (pre to post-intervention) Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent less sleep disturbance, a better outcome.
Trial Locations
- Locations (1)
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States