Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy

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

PHASE1

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-07-31

Brief Summary

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Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.

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Detailed Description

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Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.

Conditions

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Chronic Pain Opioid Abuse, Unspecified Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness-Oriented Recovery Enhancement

Group Type EXPERIMENTAL

Mindfulness-Oriented Recovery Enhancement

Intervention Type BEHAVIORAL

MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.

Conventional Support Group (SG)

Group Type ACTIVE_COMPARATOR

Conventional Support Group (SG)

Intervention Type BEHAVIORAL

The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions.

Interventions

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Mindfulness-Oriented Recovery Enhancement

MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.

Intervention Type BEHAVIORAL

Conventional Support Group (SG)

The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions.

Intervention Type BEHAVIORAL