Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy

Study Overview
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Brief Summary
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This is a one group study using a hybrid implementation design.

Detailed Description
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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).

Official Title
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Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy

Conditions
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Non-pharmacologic Management of Chronic Pain

Intervention / Treatment
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* Behavioral: Mindful Awareness in Body-Oriented Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient attending clinic and who received a referral to MABT Exclusion Criteria: Under 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |