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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02602535
Other study ID # 00078615
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date October 2020

Study information

Verified date November 2020
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic pain to prescription opioid misuse and addiction. The investigators plan to conduct a full scale clinical trial to determine whether MORE (relative to a support group control condition) can reduce symptoms of chronic pain and opioid misuse among patients who are receiving pain management in primary care via long-term opioid analgesic therapy.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Age 18-60+ - Current back pain diagnosis as determined from ICD-9 codes in claims data (including but not limited to ICD-9 diagnoses 724.x, or 847.x) or current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4) - Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days, and evidence of opioid misuse as indicated by the Current Opioid Misuse Measure - Willingness to participate in study interventions and assessments Exclusion Criteria: - Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention - Active suicidality, schizophrenia, psychotic disorder, and/or substance dependence (other than opioid dependence) - Presence of clinically unstable systemic illness judged to interfere with treatment

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-Oriented Recovery Enhancement
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
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Locations

Country Name City State
United States University of Utah Primary Care Clinics Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in nonreactivity subscale on Five Facet Mindfulness Questionnaire Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other Change in interoceptive awareness Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other Change in reinterpretation of pain sensations Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other Change in emotion regulation Emotion regulation as evidenced by responses on the Emotion Regulation Task Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other Change in positive emotion Positive emotion as evidenced by the PANAS Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other Change in cue-reactivity Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other Change in attention to positive information Attention to positive information as evidenced by the APNIS Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other Change in anhedonia Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia. Change from baseline through study completion (9 months post-treatment)
Primary Change in opioid misuse Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen Change from baseline through study completion (9 months post-treatment)
Primary Change in pain severity and interference Brief Pain Inventory Change from baseline through study completion (9 months post-treatment)
Secondary Change in opioid craving Opioid craving measure from Wasan et al. 2012 Change from baseline through study completion (9 months post-treatment)
Secondary Change in psychological distress Depression Anxiety Stress Scale Change from baseline through study completion (9 months post-treatment)
Secondary Change in opioid dose Opioid dose converted into morphine equivalents via standardized equianalgesic tables Change from baseline through study completion (9 months post-treatment)
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