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

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ClinicalTrials.gov Identifier: NCT03563911
Recruitment Status : Withdrawn (COVID pandemic)
First Posted : June 20, 2018
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid Use Chronic Pain Behavioral: Brief Mindfulness-Based Intervention (BMBI) Behavioral: Control/Nutrition Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Mindfulness-Based Intervention for Chronic Pain: A Pilot Randomized Clinical Trial
Actual Study Start Date : December 12, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Brief Mindfulness-Based Intervention
Those assigned to the Brief Mindfulness-Based Intervention (BMBI) Arm will receive BMBI.
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).

Active Comparator: Control/Nutrition Education
Those assigned to the Control/Nutrition Education Arm will receive the nutrition education intervention.
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).




Primary Outcome Measures :
  1. Cold pressor testing [ Time Frame: 1 hour ]
    Cold pressor testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity). In the cold pressor test, a participant is asked to place his or her hand and forearm 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 present study.

  2. Pressure algometer testing [ Time Frame: 1 hour ]
    Pressure algometer testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity). In the pressure algometer test, the algometer is used to apply pressure to the skin until the pain can no longer be tolerated. In the current study, we will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX).

  3. Brief Pain Inventory [ Time Frame: 4 weeks ]
    Measures: 1) pain severity= mean of items 3-6 (ranges from 0-10 with higher scores indicating greater pain severity), and 2) pain interference= mean of items 9A-9G (ranges from 0-10 with higher scores indicating greater pain interference).

  4. Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ]
    Measures: 1) Anxiety (sum of 7 items; ranges from 0-21, with higher scores indicating greater anxiety), and 2) Depression (sum of 7 items; ranges from 0-21, with higher scores indicating greater depressive symptoms).

  5. Mindful Attention Awareness Scale [ Time Frame: 4 weeks ]
    Measures mindfulness; mean of 15 items (ranges from 1 to 6, with higher scores indicating greater levels of mindfulness)

  6. Schwartz Outcome Scale [ Time Frame: 4 weeks ]
    Measures general well-being; sum of 10 items (ranges from 0 to 60, with higher scores indicating greater well-being)

  7. Toronto Mindfulness Scale-Decentering Subscale [ Time Frame: 1 hour ]
    Measures decentering; sum of 7 items (higher scores indicate greater levels of decentering)

  8. Opioid Compliance Checklist [ Time Frame: 4 weeks ]
    Measure misuse of opioid medications (scores range from 0 to 12, with higher scoring indicating greater misuse)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563911


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03563911    
Other Study ID Numbers: 2018-0864
A532007 ( Other Identifier: UW Madison )
SMPH/FAMILY MED/RES GRANTS ( Other Identifier: UW Madison )
Protocol Version 6/25/2018 ( Other Identifier: UW Madison )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations