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

Chronic Pain Clinical Trial

— MORE-JITAI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04567043
• Other study ID #: 00078615.2
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 24, 2020
• Est. completion date: September 2023

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: September 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Opioid-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center on Mindfulness and Integrative Health Intervention Development	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in opioid misuse	Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)	Baseline through post-treatment (week 8)
Other	Change in chronic pain symptoms	Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)	Baseline through post-treatment (week 8)
Other	Change in opioid dose	Opioid dose as assessed with Timeline Followback Procedure	Baseline through post-treatment (week 8)
Other	Change in self-transcendence	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)
Other	Change in mindful reinterpretation of pain sensations	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)
Primary	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
Primary	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	Change in momentary positive affect	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
Secondary	Change in momentary stress	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
Secondary	Change in heart rate variability	Changes in heart rate variability (HRV) measured via ambulatory HRV assessment	Baseline through 1-month follow-up