Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy
March 5, 2024 updated by: Kathryn A. Hansen, Vanderbilt University Medical Center
This is a one group study using a hybrid implementation design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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.
|
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
Time Frame: 24 months
|
Total number of referrals from clinicians within the clinic to MABT
|
24 months
|
|
Total number of MABT visits
Time Frame: 24 months
|
Total number of MABT visits utilized during study period
|
24 months
|
|
Number of referrals to MABT from a Psychologist
Time Frame: 24 months
|
Count of how many of the total referrals came from Psychologists
|
24 months
|
|
Number of referrals to MABT from a Nurse Practitioner
Time Frame: 24 months
|
Count of how many of the total referrals came from Nurse Practitioners
|
24 months
|
|
Number of referrals to MABT from a Physical Therapist
Time Frame: 24 months
|
Count of how many of the total referrals came from Physical Therapists
|
24 months
|
|
Number of referrals to MABT from a Massage Therapist
Time Frame: 24 months
|
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
Time Frame: 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.
|
32 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.