Brief Mindfulness and Nutrition-Based Interventions for Opioid-Treated Chronic Pain: Strategies to Ease Pain

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).

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