Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy

Completed

• Conditions: Non-pharmacologic Management of Chronic Pain
• Interventions: Behavioral: Mindful Awareness in Body-Oriented Therapy

• Registration Number: NCT05289024
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-21
• Study Start: 2022-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Patient attending clinic and who received a referral to MABT

Exclusion Criteria

• Under 18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MABT utilizers	Mindful Awareness in Body-Oriented Therapy	Chronic pain patients receiving MABT in an interdisciplinary clinic as part of their standard of care.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	32 weeks	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States