Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention (MORE-JITAI)

July 3, 2023 updated by: Eric Garland, University of Utah

Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention

This pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain on long-term opioid therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Center on Mindfulness and Integrative Health Intervention Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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
  • Presence of clinically unstable systemic illness judged to interfere with treatment
  • No access to internet (which will prevent telehealth-based treatment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Oriented Recovery Enhancement+JITAI
Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks.
Behavioral: MORE+JITAI
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. JITAI involves stress-triggered reminders to practice mindfulness skills.
Active Comparator: Supportive Psychotherapy
Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks.
Behavioral: Supporive Psychotherapy
A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in momentary craving
Time Frame: Baseline through 1-month follow-up
Craving measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more craving)
Baseline through 1-month follow-up
Change in momentary pain: numeric rating scale
Time Frame: Baseline through 1-month follow-up
Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain)
Baseline through 1-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in momentary positive affect
Time Frame: Baseline through 1-month follow-up
Positive affect measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more positive affect)
Baseline through 1-month follow-up
Change in momentary stress
Time Frame: Baseline through 1-month follow-up
Stress measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more stress)
Baseline through 1-month follow-up
Change in heart rate variability
Time Frame: Baseline through 1-month follow-up
Changes in heart rate variability (HRV) measured via ambulatory HRV assessment
Baseline through 1-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in opioid misuse
Time Frame: Baseline through post-treatment (week 8)
Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)
Baseline through post-treatment (week 8)
Change in chronic pain symptoms
Time Frame: Baseline through post-treatment (week 8)
Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
Baseline through post-treatment (week 8)
Change in opioid dose
Time Frame: Baseline through post-treatment (week 8)
Opioid dose as assessed with Timeline Followback Procedure
Baseline through post-treatment (week 8)
Change in self-transcendence
Time Frame: Baseline through post-treatment (week 8)
Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)
Baseline through post-treatment (week 8)
Change in mindful reinterpretation of pain sensations
Time Frame: Baseline through post-treatment (week 8)
Mindful reinterpretation of pain sensations measured by the Mindful Reinterpretation of Pain Sensations Scale, with higher scores indicating higher reinterpretation of pain sensations (min 0, max 45)
Baseline through post-treatment (week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

January 4, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00078615.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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