Back to resultsTreating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention (MORE-JITAI)
Primary Purpose
Chronic Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MORE+JITAI
Supporive Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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)
Sites / Locations
- Center on Mindfulness and Integrative Health Intervention Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-Oriented Recovery Enhancement+JITAI
Supportive Psychotherapy
Arm Description
Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks.
Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks.
Outcomes
Primary Outcome Measures
Change in momentary craving
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
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
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
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
Changes in heart rate variability (HRV) measured via ambulatory HRV assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04567043
Brief Title
Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
Acronym
MORE-JITAI
Official Title
Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Oriented Recovery Enhancement+JITAI
Arm Type
Experimental
Arm Description
Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks.
Arm Title
Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
MORE+JITAI
Intervention Description
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
Intervention Name(s)
Supporive Psychotherapy
Intervention Description
A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Primary Outcome Measure Information:
Title
Change in momentary craving
Description
Craving measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more craving)
Time Frame
Baseline through 1-month follow-up
Title
Change in momentary pain: numeric rating scale
Description
Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain)
Time Frame
Baseline through 1-month follow-up
Secondary Outcome Measure Information:
Title
Change in momentary positive affect
Description
Positive affect measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more positive affect)
Time Frame
Baseline through 1-month follow-up
Title
Change in momentary stress
Description
Stress measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more stress)
Time Frame
Baseline through 1-month follow-up
Title
Change in heart rate variability
Description
Changes in heart rate variability (HRV) measured via ambulatory HRV assessment
Time Frame
Baseline through 1-month follow-up
Other Pre-specified Outcome Measures:
Title
Change in opioid misuse
Description
Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)
Time Frame
Baseline through post-treatment (week 8)
Title
Change in chronic pain symptoms
Description
Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
Time Frame
Baseline through post-treatment (week 8)
Title
Change in opioid dose
Description
Opioid dose as assessed with Timeline Followback Procedure
Time Frame
Baseline through post-treatment (week 8)
Title
Change in self-transcendence
Description
Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)
Time Frame
Baseline through post-treatment (week 8)
Title
Change in mindful reinterpretation of pain sensations
Description
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)
Time Frame
Baseline through post-treatment (week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Center on Mindfulness and Integrative Health Intervention Development
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24491075
Citation
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.
Results Reference
background
Learn more about this trial
Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
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