4-week Mindfulness Program for Adults With Chronic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Mindfulness Training For Chronic Pain


Participation Criteria
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Eligibility Criteria
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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).

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
Intervention Model: Single Group Assignment
Interventional Model Description: Single-group, mixed methods repeated measures design (pre and post assessments)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Training For Chronic Pain<br>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. | Behavioral: Mindfulness Training For Chronic Pain<br>* 4-week group Mindfulness training program for adults with chronic pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Study Retention | Proportion of participants enrolled who completed the study | 4 weeks | 
| Feasibility - Session Attendance | Average sessions attended (proportion) | 4 weeks (intervention weeks 1-4) | 
| Credibility and Expectancy Questionnaire Scores | 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. | Intervention week 2 | 
| Acceptability - Intervention Satisfaction | Question assessing participants satisfaction with the intervention | 4 weeks (within one week post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Scores | 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. | Baseline and 4 weeks (pre to post-intervention) | 
| Pain Interference Scores | 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. | Baseline and 4 weeks (pre to post-intervention) | 
| Physical Functioning Scores | 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. | Baseline and 4 weeks (pre to post-intervention) | 
| Depression Short-Form 4a Scores | 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. | Baseline and 4 weeks (pre to post-intervention) | 
| Anxiety Short-Form 4a Scores | 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. | Baseline and 4 weeks (pre to post-intervention) | 
| Sleep Disturbance Short-Form 4a Scores | 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. | Baseline and 4 weeks (pre to post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness-based stress reduction, Mindfulness, chronic pain, Feasibility, Intervention