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

NCT03563911 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-12-07

No results posted yet for this study

Summary

This pilot randomized clinical trial (RCT) will randomize adults with chronic pain to one, 20-minute session of either: Brief Mindfulness-Based Intervention (BMBI) mindfulness training 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 one week 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 follow-up.

Conditions

Interventions

BEHAVIORAL

Brief Mindfulness-Based Intervention (BMBI)

The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, we will employ a brief intervention; 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 1 week (a handout and link to an online guided mindfulness practice will be provided).

BEHAVIORAL

Control/Nutrition Education

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 1 week (a handout and link to online resources will be provided).

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563911 on ClinicalTrials.gov