Mindfulness Intervention for Individuals With HIV and Chronic Pain
NCT Number: NCT06481501
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain|HIV Infections
Interventions: BEHAVIORAL: ONE Mindfulness-Oriented Recovery Enhancement
Sponsor: Florida State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2025-07-25
Locations: Brain Science and Symptom Management Center, Tallahassee, Florida, 32310, United States

Summary:
This project is a single-site, two-arm, randomized controlled pilot study examining the impact of a 2-hour version of Mindfulness-Oriented Recovery Enhancement (ONE MORE) training for individuals with HIV and chronic pain.

Primary Outcome Measures: Recruitment Feasibility, Examine recruitment rates during the 4 months of recruitment., 4 months|Intervention Adherence, Examine the percentage of participants completing their 2-hour intervention session., 2 Hours|Treatment Acceptability, Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Higher scores reflect greater acceptability., Completed immediately after the 2-hour ONE MORE training
Secondary Outcome Measures: Global Impression of Change, Treatment related improvement will be assessed with the Patient Global Impression of Change scale. Scores range from 0 to 7, with higher scores reflecting greater treatment related improvement., Completed at 2- and 4-week follow-ups
Other Outcome Measures: Acute Pain Unpleasantness, Change in acute pain unpleasantness 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 unpleasantness., Will be completed immediately before and after the 2-hour intervention session|Acute Pain Intensity, Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity., Will be completed immediately before and after the 2-hour intervention session|Daily Pain Intensity, Change in daily pain intensity from from the first post-intervention day through the 4-week follow-up will be assessed with the pain intensity item from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity., Daily for 4 weeks|Daily Pain Interference, Change in daily pain interference from from the first post-intervention day through the 4-week follow-up will be assessed with the two pain interference items from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain interference., Daily for 4 weeks|Chronic Pain, Change in chronic pain from baseline through 4-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater chronic pain., Baseline, 2 weeks post-treatment, 4 week post-treatment]|Sleep, Change in sleep from baseline through 4-week follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep., Baseline, 2 weeks post-treatment, 4 week post-treatment]|Pain Catastrophizing, Change in pain catastrophizing from baseline through 4-week follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing., Baseline, 2 weeks post-treatment, 4 week post-treatment|Depression, Change in depression from baseline through 6-week follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression., Baseline, 2 weeks post-treatment, 4 week post-treatment]|Anxiety, Change in anxiety from baseline through 4-week follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety., Baseline, 2 weeks post-treatment, 4 week post-treatment|Prescription Pain Medication Use, Change in prescription pain medication misuse from baseline through 4-week 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., Baseline, 2-weeks post-treatment, 4 weeks post-treatment|Substance Use, Change in substance misuse from baseline through 4-week follow-up will be assessed with the Severity of Substance Use Short Form 7a. Scores range from 7 to 35, with higher scores reflecting greater substance use, Baseline, 2-weeks post-treatment, 4 weeks post-treatment|Alcohol Use, Change in alcohol use from baseline through 4-week follow-up will be assessed with the PROMIS v1.0 Alcohol Use - Short Form 7a. Scores range from 7 to 35, with higher scores reflecting greater alcohol use, Baseline, 2-weeks post-treatment, 4 weeks post-treatment|Nicotine Use, Change in nicotine use from baseline through 4-week follow-up will be assessed with the Smoking: Nicotine Dependence for All Smokers - Short Form 4a. Scores range from 4 to 20, with higher scores reflecting greater nicotine use, Baseline, 2-weeks post-treatment, 4 weeks post-treatment|Mindful Pain Management Mindful Pain Management, Change in the use of mindfulness for pain management from baseline through 4-week follow-up will be assessed with the Mindful Reappraisal of Pain Scale. Scores range from 0 to 54, with higher scores reflecting greater mindful pain management., Baseline, 2 weeks post-treatment, 4 week post-treatment|Self-Transcendent Experiences Self-Transcendent Experiences, Change in the the frequency of self-transcendent experiences from baseline through 4-week follow-up will be assessed with the Nondual Awareness Dimensional Assessment. Scores range from 0 to 5, with higher scores reflecting more frequent self-transcendent experiences., Baseline, 2 weeks post-treatment, 4 week post-treatment|Self Transcendent State, Change in self-transcendent state from immediately before treatment to immediately after treatment will be assessed with the Nondual Awareness Dimensional Assessment- State Version. Scores range from 0 to 10, with higher scores reflecting deeper states of self-transcendence., Will be completed immediately before and after the 2-hour intervention session|Trait-Like Decentering, Change in meta-awareness, non-reactivity, and acceptance from baseline through 4-week follow-up will be assessed with the Metacognitive Processes of Decentering Scale. Scores range from 15 to 75, with higher scores reflecting greater emotional balance, Baseline, 2-weeks post-treatment, 4 weeks post-treatment|State-Like Decentering, Change in decentering from immediately before treatment to immediately after treatment (i.e., 2 hours later) will be assessed with the Metacognitive Processes of Decentering Scale. Scores range from 0 to 10, with higher scores reflecting greater de-centering, Will be completed immediately before and after the 2-hour intervention session|Savoring Beliefs, Change in individuals' perceptions of their ability to derive pleasure through anticipating upcoming positive events, savoring positive moments, and reminiscing about past positive experiences were measured from baseline through 4-week follow-up will be assessed with the Savoring Beliefs Inventory. Scores range from 0 to 4, with higher scores reflecting stronger enjoyment of life., Baseline, 2 weeks post-treatment, 4 week post-treatment