Madison, Wisconsin 53715


Purpose:

This pilot randomized clinical trial (RCT) will randomize adults with opioid-treated chronic pain to one, 20-minute session of either: mindfulness training (BMBI) or nutrition education (Control). Following the session, participants will be encouraged to practice a technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for 4 consecutive weeks at home. Quantitative sensory testing (with cold pressor and algometer) will be conducted before and after the session, and self-reported outcome assessments will be conducted before and after the session and at 1-week and 4-week follow-ups.


Study summary:

The proposed study is designed as a pilot randomized clinical trial (RCT), in which participants will be randomized to one, 20-minute session of either: mindfulness training (BMBI) or nutrition education (Control). Following the session, participants will be encouraged to practice a technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for 4 consecutive weeks at home. Quantitative sensory testing (cold pressor test and pressure algomter) will be conducted before and after the session, and self-reported outcome assessments will be conducted before and after the session and at 1-week and 4-week follow-ups. Participants. To gather pilot data on the effects of BMBI, the investigators will aim to enroll up to 60 participants (up to 30 in each condition). Participants will be adults with chronic non-cancer pain (daily pain for at least 3 months), treated with daily opioids for at least 3 months (daily morphine-equivalent dose ≥ 30 mgs). Each participant will receive an intervention (according to the study arm) free of charge and be compensated up to $100 ($50 for completing the in-person appointment, and $25 for completing each of the follow-up assessments by phone). Outcomes. Outcome measures were selected based on existing recommendations, including IMMPACT guidelines, for efficacy trials in chronic pain. Quantitative sensory testing (cold pressor test and pressure algometer) will be used to characterize pain processing: pain threshold (i.e., when pain is first detected), pain tolerance (i.e., the duration of time that pain can be tolerated), and pain severity (i.e., intensity of pain). In the cold pressor test, a participant will be asked to place his or her hand in an ice bath until the pain is too great to remain in the water. Consistent with past research, a 15 liter refrigerated circulator (Polyscience MX15R-30-A11B) with water temperature set as low as 1°C will be used. In the pressure algometer test, the algometer will be used to apply pressure to the skin until the pain can no longer be tolerated. The investigators will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX). Self-reported outcomes include: pain intensity and interference (9-item Brief Pain Inventory), anxiety and depression (14-item Hospital Anxiety and Depression Scale), trait mindfulness (15-item Mindful Attention Awareness Scale), psychological well-being (10-item Schwartz Outcome Scale), opioid misuse (12-item Opioid Compliance Checklist), opioid use (with calendar), the amount of at home practice over the 4-week follow-up period (with calendar), state decentering (7-item Decentering Subscale of the Toronto Mindfulness Scale), state pain intensity (1 item from the Brief Pain Inventory), state pain unpleasantness (1-item rated on 0-10 scale), state anxiety (1-item rated on 0-10 scale), state distress (1-item rated on 0-10 scale), state relaxation (1-item rated on 0-10 scale), and state desire for opioids (1-item rated on 0-10 scale), and outcome expectancies (5-item Outcome Expectancies Questionnaire). Assessments are anticipated to last 90 minutes total (30 minutes at the in-person appointment and 30 minutes for each follow-up assessment). Procedure. Participants will be recruited primarily via flyers and postings in newspapers and on the Internet. Prospective participants will be screened by phone (about 30 minutes). Provisionally eligible participants will be asked to attend a 1-hour appointment, which will begin with informed consent procedures (5-10 minutes) and a preintervention assessment (about 20 minutes; includes demographics questionnaire, self-report outcome measures, and quantitative sensory testing). Individuals who do not meet inclusion criteria (see "Participants") or who exhibit atypical responses to quantitative sensory testing (e.g., immediately remove hand from cold water bath) will be excluded from the study and compensated with $20. Eligible participants will be randomized to a condition, complete a 20-minute session of either BMBI or Control, and undergo a postintervention assessment (about 10 minutes; includes self-report outcome measures and quantitative sensory testing). Following the assessment, participants will be encouraged to practice the technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for 4 weeks at home and to track their practice and opioid use during the follow-up period; the follow-up assessments will be conducted over the phone by a research assistant and include the self-report outcome measures (no quantitative sensory testing). All study procedures are anticipated to last 2 hours and 30 minutes (30 minutes for screening, 1 hour for in-person appointment, and 30 minutes for each follow-up assessment). Interventions: The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, the investigators will employ a brief intervention (i.e., one, 20-minute session) that could be delivered in routine clinical care, e.g., in primary care, and that could overcome cost and time/effort barriers associated with longer treatments. The 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes). BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 4 weeks (a handout and link to an online guided mindfulness practice will be provided). The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain. Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI. The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes). Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 4 weeks (a handout and link to online resources will be provided).


Criteria:

Inclusion Criteria: 1. English-speaking 2. ≥ 18 years old 3. Chronic non-cancer pain (daily pain for at least 3 months) 4. Average daily pain score ≥3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory) 5. Treatment with ≥30 mg/day of morphine-equivalent dose for ≥3 months 6. Capable of giving informed consent 7. Willing to complete all study activities Exclusion Criteria: 1. Cancer pain 2. Current pregnancy 3. Diagnosed with psychotic or bipolar (mania) disorders ("active" in the prior 12 months) 4. Inability to safely or reliably participate in the study 5. Regular mindfulness meditation practice


NCT ID:

NCT03563911


Primary Contact:

Andrew S McClintock, PhD
Phone: 608-263-4550
Email: asmcclintock@wisc.edu


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53715
United States

Andrew S McClintock
Email: asmcclintock@wisc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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