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

Not Applicable

Active, not recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: MORE+JITAI; Behavioral: Supporive Psychotherapy

• Registration Number: NCT04567043
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study Start: 2020-09-24
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-28
• Primary Completion: 2023-01-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Oriented Recovery Enhancement+JITAI	MORE+JITAI	Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks.
Supportive Psychotherapy	Supporive Psychotherapy	Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 heart rate variability	Baseline through 1-month follow-up	Changes in heart rate variability (HRV) measured via ambulatory HRV assessment

Trial Locations

Locations (1)

Center on Mindfulness and Integrative Health Intervention Development; 🇺🇸 Salt Lake City, Utah, United States