Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy
Primary Purpose
Chronic Pain, Opioid Abuse, Unspecified Use
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement
Conventional Support Group (SG)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- chronic pain diagnosis (ICD-9 diagnoses 338.xx)
- treatment with prescription opioids for > 3 months
Exclusion Criteria:
- prior mindfulness training
- persons who are experiencing acute opioid withdrawal
- suicidal ideation
- psychosis
Sites / Locations
- FSU College of Social Work
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-Oriented Recovery Enhancement
Conventional Support Group (SG)
Arm Description
Outcomes
Primary Outcome Measures
Pain severity, pain functional interference
Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
Opioid craving
Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
Opioid misuse behaviors
Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
Well-being
Change in well-being as measured by the WHO-5
Secondary Outcome Measures
Attentional bias
Change in attentional bias as measured by a dot probe task
Psychophysiological cue-reactivity
Change in psychophysiological cue-reactivity
Emotional response inhibition
Change in emotional response inhibition
Pain coping strategies
Change in reinterpretation of pain sensations, catastrophizing, and suppression.
Anhedonia
Change in anhedonia
Fear of pain
Change in fear of pain
Mindfulness
Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale
Positive reappraisal
Change in positive reappraisal
Full Information
NCT ID
NCT01505101
First Posted
January 4, 2012
Last Updated
August 4, 2014
Sponsor
Florida State University
Collaborators
National Institute on Drug Abuse (NIDA), Fahs Beck Fund for Research and Experimentation
1. Study Identification
Unique Protocol Identification Number
NCT01505101
Brief Title
Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy
Official Title
Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institute on Drug Abuse (NIDA), Fahs Beck Fund for Research and Experimentation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Abuse, Unspecified Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Oriented Recovery Enhancement
Arm Type
Experimental
Arm Title
Conventional Support Group (SG)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement
Intervention Description
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
Intervention Name(s)
Conventional Support Group (SG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain severity, pain functional interference
Description
Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
Time Frame
Baseline, immediately following treatment, and at 3 month follow-up
Title
Opioid craving
Description
Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
Time Frame
Baseline, immediately following treatment, and at 3 month follow-up
Title
Opioid misuse behaviors
Description
Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
Time Frame
Baseline, immediately following treatment, and at 3 month follow-up
Title
Well-being
Description
Change in well-being as measured by the WHO-5
Time Frame
Baseline, immediately following treatment, and at 3 month follow-up
Secondary Outcome Measure Information:
Title
Attentional bias
Description
Change in attentional bias as measured by a dot probe task
Time Frame
Baseline and immediately following treatment
Title
Psychophysiological cue-reactivity
Description
Change in psychophysiological cue-reactivity
Time Frame
Baseline and immediately following treatment
Title
Emotional response inhibition
Description
Change in emotional response inhibition
Time Frame
Baseline and immediately following treatment
Title
Pain coping strategies
Description
Change in reinterpretation of pain sensations, catastrophizing, and suppression.
Time Frame
Baseline, intervention midpoint, and immediately following treatment
Title
Anhedonia
Description
Change in anhedonia
Time Frame
Baseline and immediately following treatment
Title
Fear of pain
Description
Change in fear of pain
Time Frame
Baseline and immediately following treatment
Title
Mindfulness
Description
Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale
Time Frame
Baseline, intervention midpoint, and immediately following treatment
Title
Positive reappraisal
Description
Change in positive reappraisal
Time Frame
Baseline and immediately following treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic pain diagnosis (ICD-9 diagnoses 338.xx)
treatment with prescription opioids for > 3 months
Exclusion Criteria:
prior mindfulness training
persons who are experiencing acute opioid withdrawal
suicidal ideation
psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Garland, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
FSU College of Social Work
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306-2570
Country
United States
12. IPD Sharing Statement
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Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy
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