Behavioral Interventions for Chronic Pain and Opioid-Related Problems

Chronic Pain Clinical Trial

Official title:

Behavioral Interventions for Chronic Pain and Opioid-Related Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298269
• Other study ID #: 1618
• Status: Completed
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age 18-60+
• Current chronic pain condition
• Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days

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 severe substance dependence (other than opioid dependence)
• Opioid misuse as determined by Current Opioid Misuse Measure

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Mindfulness-Oriented Recovery Enhancement
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.
• Supportive Counseling
A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.

Locations

Country	Name	City	State
United States	College of Social Work	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 cue-reactivity	Change in EEG responses during a cue-reactivity task	Change from baseline through 8 weeks
Other	Change in emotion regulation	Change in EEG responses during an emotion regulation task	Change from baseline through 8 weeks
Primary	Change in pain symptoms	Pain severity and interference as measured by the Brief Pain Inventory	Change from baseline through study completion (9 months post-treatment)
Primary	Change in aberrant drug-related behaviors	Aberrant drug-related behaviors 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)
Secondary	Change in emotional distress	Distress measured by the 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)
Secondary	Change in opioid craving	Craving measured by visual analogue scale	Change from baseline through study completion (9 months post-treatment)
Secondary	Change in interoceptive awareness	Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness	Change from baseline through 8 weeks
Secondary	Change in reappraisal	Reappraisal measured by the Emotion Regulation Questionnaire	Change from baseline through 8 weeks
Secondary	Change in savoring	Savoring measured by the brief Ways of Savoring checklist	Change from baseline through 8 weeks
Secondary	Change in meditative experiences	As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment	Change from baseline through 8 weeks
Secondary	Change in body sensations	Change in pleasant, neutral, and unpleasant body sensations as measured by body map	Change from baseline through 8 weeks