4-week Mindfulness Program for Adults With Chronic Pain

NCT ID: NCT03495856

Last Updated: 2019-09-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2018-10-26

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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-group, mixed methods repeated measures design (pre and post assessments)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Training For Chronic Pain

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness Training For Chronic Pain

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

Intervention Type BEHAVIORAL

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carrie Brintz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38434590 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2KR941702

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

17-2948

Identifier Type: -

Identifier Source: org_study_id

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