4-week Mindfulness Program for Adults With Chronic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness Training For Chronic Pain

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Mindfulness Training For Chronic Pain; 4-week group Mindfulness training program for adults with chronic pain

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale Scores	Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.	Baseline and 4 weeks (pre to post-intervention)
Positive Affect and Well-being Scores	Positive Affect and Well-being Scale - 9 items. This scale comes from the Neurological Quality of Life Measurement System (Neuro QOL). Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Higher scores indicate greater positive affect and well-being, a better outcome.	Baseline and 4 weeks (pre to post-intervention)
Pain Catastrophizing Scale Scores	Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.	Baseline and 4 weeks (pre to post-intervention)
Chronic Pain Acceptance Scores	Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome.	Baseline and 4 weeks (pre to post-intervention)
Trait Mindfulness Scores	Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.	Baseline and 4 weeks (pre to post-intervention)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Carrie Brintz, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2018
• Primary Completion (ACTUAL): October 26, 2018
• Study Completion (ACTUAL): October 26, 2018

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (ACTUAL): April 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: chronic pain; Feasibility; Mindfulness; Intervention; Mindfulness-based stress reduction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 17-2948; 2KR941702 (OTHER_GRANT: North Carolina Translational and Clinical Sciences Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No