Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
MORE-JITAI
Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Sep 2020
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJuly 5, 2023
July 1, 2023
2.3 years
September 22, 2020
July 3, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change in momentary craving
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
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 Outcomes (3)
Change in momentary positive affect
Baseline through 1-month follow-up
Change in momentary stress
Baseline through 1-month follow-up
Change in heart rate variability
Baseline through 1-month follow-up
Other Outcomes (5)
Change in opioid misuse
Baseline through post-treatment (week 8)
Change in chronic pain symptoms
Baseline through post-treatment (week 8)
Change in opioid dose
Baseline through post-treatment (week 8)
- +2 more other outcomes
Study Arms (2)
Mindfulness-Oriented Recovery Enhancement+JITAI
EXPERIMENTALParticipants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks.
Supportive Psychotherapy
ACTIVE COMPARATORParticipants will attend a telehealth supportive psychotherapy group weekly for eight weeks.
Interventions
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.
A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112, United States
Related Publications (2)
Garland EL, Manusov EG, Froeliger B, Kelly A, Williams JM, Howard MO. Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial. J Consult Clin Psychol. 2014 Jun;82(3):448-459. doi: 10.1037/a0035798. Epub 2014 Feb 3.
PMID: 24491075BACKGROUNDGarland EL, Gullapalli BT, Prince KC, Hanley AW, Sanyer M, Tuomenoksa M, Rahman T. Zoom-Based Mindfulness-Oriented Recovery Enhancement Plus Just-in-Time Mindfulness Practice Triggered by Wearable Sensors for Opioid Craving and Chronic Pain. Mindfulness (N Y). 2023 May 24:1-17. doi: 10.1007/s12671-023-02137-0. Online ahead of print.
PMID: 37362184DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 22, 2020
First Posted
September 28, 2020
Study Start
September 24, 2020
Primary Completion
January 4, 2023
Study Completion
September 1, 2023
Last Updated
July 5, 2023
Record last verified: 2023-07