MORE-JITAI: Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
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| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in momentary craving [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)
- Change in momentary pain: numeric rating scale [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)
Secondary Outcome Measures
- Change in momentary positive affect [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)
- Change in momentary stress [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)
- Change in heart rate variability [Baseline through 1-month follow-up]
Changes in heart rate variability (HRV) measured via ambulatory HRV assessment
Other Outcome Measures
- Change in opioid misuse [Baseline through post-treatment (week 8)]
Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)
- Change in chronic pain symptoms [Baseline through post-treatment (week 8)]
Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
- Change in opioid dose [Baseline through post-treatment (week 8)]
Opioid dose as assessed with Timeline Followback Procedure
- Change in self-transcendence [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)
- Change in mindful reinterpretation of pain sensations [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for
90 days
- Willingness to participate in study interventions and assessments
Exclusion Criteria:
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Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
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Active suicidality, schizophrenia, psychotic disorder
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Presence of clinically unstable systemic illness judged to interfere with treatment
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No access to internet (which will prevent telehealth-based treatment)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center on Mindfulness and Integrative Health Intervention Development | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Utah
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 00078615.2