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OpenTrials
Completed

NCT Number: NCT05289024

Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy

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

Completed

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Key information

Conditions

Non-pharmacologic Management of Chronic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient attending clinic and who received a referral to MABT

Exclusion criteria

  • Under 18

Treatment and study plan

Mindful Awareness in Body-oriented Therapy

Behavioral

Up to 8 individually delivered clinical sessions

Primary outcomes

  1. Total number of referrals to MABT

    Time frame: 24 months

    Total number of referrals from clinicians within the clinic to MABT

  2. Total number of MABT visits

    Time frame: 24 months

    Total number of MABT visits utilized during study period

  3. Number of referrals to MABT from a Psychologist

    Time frame: 24 months

    Count of how many of the total referrals came from Psychologists

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.