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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04567043
Other study ID # 00078615.2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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