Non-pharmacologic Management of Chronic PainNCT05289024
Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy
An observational study of Non-pharmacologic Management of Chronic Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is a one group study using a hybrid implementation design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-pharmacologic Management of Chronic Pain
- What is being tested?
- Mindful Awareness in Body-Oriented Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic pain patients attending an integrative health center
Who may be able to join
- Patient attending clinic and who received a referral to MABT
Who cannot join
- Under 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
This is a one group study using a hybrid implementation design.
Read the 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).
- Being tested
- Mindful Awareness in Body-Oriented Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Awareness in Body-Oriented TherapyBehavioural
Up to 8 individually delivered clinical sessions
| Study group | Role | What they receive |
|---|---|---|
| MABT utilizers | Chronic pain patients receiving MABT in an interdisciplinary clinic as part of their standard of care. Receives: Behavioral: Mindful Awareness in Body-Oriented Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of referrals to MABT
Total number of referrals from clinicians within the clinic to MABT
Measured: 24 months
Total number of MABT visits
Total number of MABT visits utilized during study period
Measured: 24 months
Number of referrals to MABT from a Psychologist
Count of how many of the total referrals came from Psychologists
Measured: 24 months
Number of referrals to MABT from a Nurse Practitioner
Count of how many of the total referrals came from Nurse Practitioners
Measured: 24 months
Number of referrals to MABT from a Physical Therapist
Count of how many of the total referrals came from Physical Therapists
Measured: 24 months
Number of referrals to MABT from a Massage Therapist
Count of how many of the total referrals came from Massage Therapists
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-pharmacologic Management of Chronic PainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Kathryn A. Hansen, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289024
- Sponsor's protocol ID
- 201931
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen KA, Abu-Rish Blakeney E, Price CJ. Implementation Outcomes From a Pilot Study of Mindful Awareness in Body-Oriented Therapy (MABT) as a Chronic Pain Treatment Modality in an Integrative Health Clinic. Glob Adv Integr Med Health. 2025 Feb 7;14:27536130251319244. doi: 10.1177/27536130251319244. eCollection 2025 Jan-Dec.
PubMed 39925451
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy
- ClinicalTrials.gov ID
- NCT05289024
- Acronym / sponsor ID
- 201931
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MABT utilizers | – | Behavioral: Mindful Awareness in Body-Oriented TherapyChronic pain patients receiving MABT in an interdisciplinary clinic as part of their standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic pain patients attending an integrative health center
Key inclusion criteria (1 listed)
- Patient attending clinic and who received a referral to MABT
Key exclusion criteria (1 listed)
- Under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Awareness in Body-Oriented TherapyUp to 8 individually delivered clinical sessions | Behavioural | MABT utilizers |
Primary outcome
Total number of referrals to MABT
Time frame: 24 months
Total number of referrals from clinicians within the clinic to MABT
Total number of MABT visits
Time frame: 24 months
Total number of MABT visits utilized during study period
Number of referrals to MABT from a Psychologist
Time frame: 24 months
Count of how many of the total referrals came from Psychologists
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
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
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
1 secondary outcome
Health related quality of life
Time frame: 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 39925451Hansen KA, Abu-Rish Blakeney E, Price CJ. Implementation Outcomes From a Pilot Study of Mindful Awareness in Body-Oriented Therapy (MABT) as a Chronic Pain Treatment Modality in an Integrative Health Clinic. Glob Adv Integr Med Health. 2025 Feb 7;14:27536130251319244. doi: 10.1177/27536130251319244. eCollection 2025 Jan-Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-pharmacologic Management of Chronic Pain, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of referrals to MABT (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.