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4-week Mindfulness Program for Adults With Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training For Chronic Pain
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Mindfulness-based stress reduction, Mindfulness, chronic pain, Feasibility, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Training For Chronic Pain

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility - Study Retention
Proportion of participants enrolled who completed the study
Feasibility - Session Attendance
Average sessions attended (proportion)
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.
Acceptability - Intervention Satisfaction
Question assessing participants satisfaction with the intervention

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 21, 2018
Last Updated
July 30, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03495856
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Mindfulness-based stress reduction, Mindfulness, chronic pain, Feasibility, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-group, mixed methods repeated measures design (pre and post assessments)
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Training For Chronic Pain
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training For Chronic Pain
Intervention Description
4-week group Mindfulness training program for adults with chronic pain
Primary Outcome Measure Information:
Title
Feasibility - Study Retention
Description
Proportion of participants enrolled who completed the study
Time Frame
4 weeks
Title
Feasibility - Session Attendance
Description
Average sessions attended (proportion)
Time Frame
4 weeks (intervention weeks 1-4)
Title
Credibility and Expectancy Questionnaire Scores
Description
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.
Time Frame
Intervention week 2
Title
Acceptability - Intervention Satisfaction
Description
Question assessing participants satisfaction with the intervention
Time Frame
4 weeks (within one week post-intervention)
Secondary Outcome Measure Information:
Title
Pain Intensity Scores
Description
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.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Pain Interference Scores
Description
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.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Physical Functioning Scores
Description
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.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Depression Short-Form 4a Scores
Description
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.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Anxiety Short-Form 4a Scores
Description
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.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Sleep Disturbance Short-Form 4a Scores
Description
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.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Other Pre-specified Outcome Measures:
Title
Perceived Stress Scale Scores
Description
Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Positive Affect and Well-being Scores
Description
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.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Pain Catastrophizing Scale Scores
Description
Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Chronic Pain Acceptance Scores
Description
Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome.
Time Frame
Baseline and 4 weeks (pre to post-intervention)
Title
Trait Mindfulness Scores
Description
Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.
Time Frame
Baseline and 4 weeks (pre to post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Brintz, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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4-week Mindfulness Program for Adults With Chronic Pain

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