Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain

NCT ID: NCT02935621

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2022-12-15

Brief Summary

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The central aim of this proposed study is to test a multimodal, mindfulness-oriented intervention designed to disrupt the risk chain leading to prescription opioid dose escalation, opioid misuse and opioid addiction, which are mounting threats to active duty service members and Veterans with chronic pain conditions, who may develop disordered opioid use as a consequence of long-term opioid pharmacotherapy.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness-Oriented Recovery Enhancement

Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.

Group Type EXPERIMENTAL

Mindfulness-Oriented Recovery Enhancement (MORE)

Intervention Type BEHAVIORAL

Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.

Support Group

Participants will attend a support group weekly for eight weeks.

Group Type ACTIVE_COMPARATOR

Support Group

Intervention Type BEHAVIORAL

A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Interventions

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Mindfulness-Oriented Recovery Enhancement (MORE)

Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.

Intervention Type BEHAVIORAL

Support Group

A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* men/women ≥18 years of age
* ability to understand and speak the English language
* current chronic pain diagnosis (including but not limited to ICD-9 diagnoses 338.0, 338.2xx, 338.
* current use of prescription opioids for \>3 consecutive months.

Exclusion Criteria

* Mindfulness training experience (participation in MBSR/MBRP)
* opioid withdrawal evidenced by score ≥13 on the Clinical Opiate Withdrawal Scale
* current cancer diagnosis
* having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Eric Garland

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Garland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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George Wahlen VA Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00091781

Identifier Type: -

Identifier Source: org_study_id

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