- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03677882
A Brief Mind-Body Bridging Intervention for Suicidal Ideation
February 8, 2024 updated by: VA Salt Lake City Health Care System
A Randomized Pilot Study of a Brief Mind-Body Bridging Intervention for Suicidal Ideation
The aim of this study is to determine whether a Brief Mind-Body Bridging Intervention for Suicidal Ideation (MBB-SI) will result in short or longer-term reduction of psychological factors associated with suicidal ideation (SI) and/or suicide-related behaviors (SRB's) compared to Treatment as Usual (TAU).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Don Glover, PhD
- Phone Number: 2325 8015821565
- Email: don.glover@va.gov
Study Contact Backup
- Name: Jessica Vasa, LCSW
- Phone Number: 8015821565
- Email: jessica.vasa@va.gov
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84148
- George E. Wahlen Department of Veterans Affairs Medical Center
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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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subjects will be Veterans aged 18-80 admitted to Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) with addictive disorders and/or co-occurring psychiatric disorder with suicide risk factors.
Exclusion Criteria:
- None
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as Usual (TAU)
Participants assigned to Treatment As Usual (TAU) will receive the normal standard of care treatment from the Suicide Prevention Team and the Mental Health Service which may include individual therapy, group therapy, and/or medication therapy, all as decided by the individual and his/her doctor.
Treatment as usual also includes monitoring by the Suicide Prevention Team.
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Experimental: Treatment As Usual with Mind-Body Bridging (TAU + MBB)
Participants assigned to TAU + MBB will will receive treatment from the Suicide Prevention Team and the Mental Health Service, AND will be asked to participate in consisting of three to eight 60-minute sessions that will occur consecutively.
Each group will be led by a trained MBB facilitator.
Participants will receive a workbook at the beginning of the training that contains an explanation of all the major concepts involved in Mind Body Bridging.
The workbook has homework assignments to be completed daily between group sessions.
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Participants assigned to TAU + MBB will will receive treatment from the Suicide Prevention Team and the Mental Health Service, AND will be asked to participate in consisting of three to eight 60-minute sessions that will occur consecutively.
Each group will be led by a trained MBB facilitator.
Participants will receive a workbook at the beginning of the training that contains an explanation of all the major concepts involved in Mind Body Bridging.
The workbook has homework assignments to be completed daily between group sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frequency and/or intensity of suicidal ideation
Time Frame: Weekly during the intervention, one-month post-intervention, three months post-intervention, six months post-intervention
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Determine if there is a significant difference in the frequency and/or intensity of suicidal ideation, as measured by the Beck Scale for Suicide Ideation (BSS) among the MBB-SI + TAU cohort compared to the TAU.
We will use the total BSS score, ranging from 0 to 38.
Increased scores reflect greater suicide risk.
|
Weekly during the intervention, one-month post-intervention, three months post-intervention, six months post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: William Marchand, MD, VA Salt Lake City HCS
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)
December 18, 2018
Primary Completion (Actual)
January 31, 2023
Study Completion (Actual)
January 31, 2023
Study Registration Dates
First Submitted
September 10, 2018
First Submitted That Met QC Criteria
September 17, 2018
First Posted (Actual)
September 19, 2018
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VASaltLakeCity
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.
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