Chronic Pain
Conditions
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.
Interventions
BEHAVIORALMORE+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.
BEHAVIORALSupporive Psychotherapy
A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in momentary craving | Baseline through 1-month follow-up | 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 | Baseline through 1-month follow-up | Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in momentary positive affect | Baseline through 1-month follow-up | 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 | Baseline through 1-month follow-up | 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 | Baseline through 1-month follow-up | Changes in heart rate variability (HRV) measured via ambulatory HRV assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid misuse | Baseline through post-treatment (week 8) | Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68) |
| Change in opioid dose | Baseline through post-treatment (week 8) | Opioid dose as assessed with Timeline Followback Procedure |
| Change in chronic pain symptoms | Baseline through post-treatment (week 8) | Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10) |
| Change in self-transcendence | Baseline through post-treatment (week 8) | Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65) |
| Change in mindful reinterpretation of pain sensations | Baseline through post-treatment (week 8) | 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) |
Countries
United States
Outcome results
None listed