Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05289024
• Collaborator: University of Washington (Other)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-pharmacologic Management of Chronic Pain	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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Total number of referrals to MABT [24 months]

   Total number of referrals from clinicians within the clinic to MABT

2. Total number of MABT visits [24 months]

   Total number of MABT visits utilized during study period

3. Number of referrals to MABT from a Psychologist [24 months]

   Count of how many of the total referrals came from Psychologists

4. Number of referrals to MABT from a Nurse Practitioner [24 months]

   Count of how many of the total referrals came from Nurse Practitioners

5. Number of referrals to MABT from a Physical Therapist [24 months]

   Count of how many of the total referrals came from Physical Therapists

6. Number of referrals to MABT from a Massage Therapist [24 months]

   Count of how many of the total referrals came from Massage Therapists

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient attending clinic and who received a referral to MABT

Exclusion Criteria:

• Under 18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Vanderbilt University Medical Center
• University of Washington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathryn A. Hansen, Medical Director, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT05289024
• Other Study ID Numbers: 201931
• First Posted: Mar 21, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Aug 23, 2022