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

NCT ID: NCT04567043

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness-Oriented Recovery Enhancement+JITAI

Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks.

Group Type EXPERIMENTAL

MORE+JITAI

Intervention Type BEHAVIORAL

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.

Supportive Psychotherapy

Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks.

Group Type ACTIVE_COMPARATOR

Supporive Psychotherapy

Intervention Type BEHAVIORAL

A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Eric Garland

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center on Mindfulness and Integrative Health Intervention Development

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24491075 (View on PubMed)

Garland 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.

Reference Type DERIVED
PMID: 37362184 (View on PubMed)

Other Identifiers

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00078615.2

Identifier Type: -

Identifier Source: org_study_id

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