Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy

This is a one group study using a hybrid implementation design.

Study Overview

• Status: Completed
• Conditions: Non-pharmacologic Management of Chronic Pain
• Intervention / Treatment: Behavioral: Mindful Awareness in Body-Oriented Therapy

Detailed Description

The proposed pilot study will collect preliminary data to support a larger hybrid effectiveness-implementation study designed to examine the implementation of the evidence-based Mindful Awareness in Body-oriented Therapy (MABT), delivered by massage therapists, on patient and implementation science outcomes in an interdisciplinary chronic pain clinic. The combined foci of this mixed-methods pilot study is expected to provide an indication of implementation success, highlight implementation processes, and show treatment effectiveness on health outcomes.1 MABT is a mind-body therapy designed to teach interoceptive awareness skills for symptom management and emotion regulation. The proposed pilot study uses mixed methods and a single-group repeated measures design to explore MABT implementation and to estimate the effect of MABT to reduce symptomatic distress in the treatment of chronic pain at the Osher Center for Integrative Medicine at Vanderbilt Clinic (OCIM).

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chronic pain patients attending an integrative health center

Description

Inclusion Criteria:

• Patient attending clinic and who received a referral to MABT

Exclusion Criteria:

• Under 18

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MABT utilizers; Chronic pain patients receiving MABT in an interdisciplinary clinic as part of their standard of care.	Behavioral: Mindful Awareness in Body-Oriented Therapy; Up to 8 individually delivered clinical sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of referrals to MABT	Total number of referrals from clinicians within the clinic to MABT	24 months
Total number of MABT visits	Total number of MABT visits utilized during study period	24 months
Number of referrals to MABT from a Psychologist	Count of how many of the total referrals came from Psychologists	24 months
Number of referrals to MABT from a Nurse Practitioner	Count of how many of the total referrals came from Nurse Practitioners	24 months
Number of referrals to MABT from a Physical Therapist	Count of how many of the total referrals came from Physical Therapists	24 months
Number of referrals to MABT from a Massage Therapist	Count of how many of the total referrals came from Massage Therapists	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	PROMIS-29 This 29 question survey contains 7 domains each captured by 4 questions using a 5 point Likert scale with 0 being the least and 5 representing the most of each concept. the 29th question is an 11 point pain scale with 0 being no pain and 10 being the worst pain.	32 weeks

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 201931

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No