Chronic Pain
Conditions
Keywords
Mindfulness
Brief summary
This study will be a single-site, two-arm randomized controlled trial conducted among chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually via a HIPAA compliant virtual meeting platform.
Interventions
BEHAVIORALOne MORE
One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* men/women ≥18 years of age * current chronic pain diagnosis * reporting pain ≥3 on 0-10 scale
Exclusion criteria
* unstable illness judged by clinician to interfere with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in pain catastrophizing from baseline through 3-month follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in pain intensity from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity. |
| Pain Interference | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in pain interference from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 20, with higher scores reflecting greater pain interference. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in anxiety from baseline through 3-month follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety. |
| Prescription Pain Medication Misuse | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in prescription pain medication misuse from baseline through 3-month follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse. |
| Trait Mindfulness | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in trait mindfulness from baseline through 3-month follow-up will be assessed with the Toronto Mindfulness Scale - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait mindfulness. |
| Physical Function | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in physical function from baseline through 3-month follow-up will be assessed with the PROMIS Physical Functioning Short Form. Scores range from 6 to 30, with higher scores reflecting greater physical function. |
| Acute Pain | Will be completed immediately before and after the 2-hour, One MORE intervention. | Change in acute pain will be measured with an individual item (How unpleasant is your pain, right now?) rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain. |
| Decentering | Will be completed immediately before and after the 2-hour, One MORE intervention. | Change in decentering will be measured with the state version of the Metacognitive Processes of Decentering scale. Scores range from 0 to 10, with higher scores reflecting greater decentering. |
| Self-Transcendent State | Will be completed immediately before and after the 2-hour, One MORE intervention. | Change in self-transcendent state will be measured with the Nondual Awareness Dimensional Assessment - State Version. Scores range from 0 to 10, with higher scores reflecting greater self-transcendence. |
| Trait Self-Transcendence | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in trait self-transcendence from baseline through 3-month follow-up will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait self-transcendence. |
| Sleep | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in sleep from baseline through 3-month follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep. |
| Depression | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | Change in depression from baseline through 3-month follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression. |
Countries
United States
Outcome results
None listed