4-week Mindfulness Program for Adults With Chronic Pain

NCT03495856 | Completed Results

• 2 other identifiers: 17-29482KR941702
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Mindfulness-based stress reduction; Mindfulness; chronic pain; Feasibility; Intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Pain Intensity Scores

  Baseline and 4 weeks (pre to post-intervention)

• Pain Interference Scores

  Baseline and 4 weeks (pre to post-intervention)

• Physical Functioning Scores

  Baseline and 4 weeks (pre to post-intervention)

• Depression Short-Form 4a Scores

  Baseline and 4 weeks (pre to post-intervention)

• Anxiety Short-Form 4a Scores

  Baseline and 4 weeks (pre to post-intervention)

Other Outcomes (5)

• Perceived Stress Scale Scores

  Baseline and 4 weeks (pre to post-intervention)

• Positive Affect and Well-being Scores

  Baseline and 4 weeks (pre to post-intervention)

• Pain Catastrophizing Scale Scores

  Baseline and 4 weeks (pre to post-intervention)

Study Arms (1)

Mindfulness Training For Chronic Pain

EXPERIMENTAL

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

Interventions

Mindfulness Training For Chronic Pain BEHAVIORAL

4-week group Mindfulness training program for adults with chronic pain

Mindfulness Training For Chronic Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Brintz CE, Polser G, Coronado RA, French B, Faurot KR, Gaylord SA. Are Formal and Informal Home Mindfulness Practice Quantities Associated With Outcomes? Results From a Pilot Study of a Four-Week Mindfulness Intervention for Chronic Pain Management. Glob Adv Integr Med Health. 2024 Feb 29;13:27536130241236775. doi: 10.1177/27536130241236775. eCollection 2024 Jan-Dec.

  PMID: 38434590 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Carrie Brintz
• Organization: University of North Carolina School of Medicine

carrie_brintz@med.unc.edu

919-445-6109

Study Officials

• Carrie Brintz, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group, mixed methods repeated measures design (pre and post assessments)

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 12, 2018
• Study Start: April 23, 2018
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-03

Locations

US (1)