Clinical trial NCT03495856: 4-week Mindfulness Program for Adults With Chronic Pain
Official title: Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Mindfulness-based stress reduction
Mindfulness
chronic pain
Feasibility
Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2018-04-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group, mixed methods repeated measures design (pre and post assessments)
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Feasibility - Study Retention
timeFrame: 4 weeks
measure: Feasibility - Session Attendance
timeFrame: 4 weeks (intervention weeks 1-4)
measure: Credibility and Expectancy Questionnaire Scores
timeFrame: Intervention week 2
measure: Acceptability - Intervention Satisfaction
timeFrame: 4 weeks (within one week post-intervention)
Secondary outcomes:
measure: Pain Intensity Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Pain Interference Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Physical Functioning Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Depression Short-Form 4a Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Anxiety Short-Form 4a Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Sleep Disturbance Short-Form 4a Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
Other outcomes:
measure: Perceived Stress Scale Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Positive Affect and Well-being Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Pain Catastrophizing Scale Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Chronic Pain Acceptance Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
measure: Trait Mindfulness Scores
timeFrame: Baseline and 4 weeks (pre to post-intervention)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carrie Brintz, PhD
role: PRINCIPAL_INVESTIGATOR
References: