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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement+JITAI | Experimental | Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks. |
|
| Supportive Psychotherapy | Active Comparator | Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORE+JITAI | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in momentary stress |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in chronic pain symptoms |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center on Mindfulness and Integrative Health Intervention Development | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24491075 | Background | 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. | |
| 37362184 | Derived |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Supporive Psychotherapy | Behavioral | A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist. |
|
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 |
| Change in heart rate variability | Changes in heart rate variability (HRV) measured via ambulatory HRV assessment | Baseline through 1-month follow-up |
Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
| Baseline through post-treatment (week 8) |
| Change in opioid dose | Opioid dose as assessed with Timeline Followback Procedure | Baseline through post-treatment (week 8) |
| 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) |
| 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) |
| 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. |