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A Brief Mind-Body Bridging Intervention for Suicidal Ideation

Primary Purpose

Suicidal Ideation, Mind Body Bridging

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind Body Bridging Group Session
Sponsored by
VA Salt Lake City Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring mind body bridging, mindfulness, suicidal ideation, suicide related behaviors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects will be Veterans aged 18-70 with psychiatric and/or addictive disorders who are on the High Risk Suicide List because of suicidal ideations and/or behaviors.

Exclusion Criteria:

  • Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.

Sites / Locations

  • George E. Wahlen Department of Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual (TAU)

Treatment As Usual with Mind-Body Bridging (TAU + MBB)

Arm Description

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.

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 four, 90-minute Mind Body Bridging group sessions that will occur for four weeks in a row. Each group will involve up to 15 participants and will be led by a trained MBB facilitator.

Outcomes

Primary Outcome Measures

Change in frequency and/or intensity of suicidal ideation
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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2018
Last Updated
April 24, 2019
Sponsor
VA Salt Lake City Health Care System
Collaborators
Mind Body Bridging Charity
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1. Study Identification

Unique Protocol Identification Number
NCT03677882
Brief Title
A Brief Mind-Body Bridging Intervention for Suicidal Ideation
Official Title
A Randomized Pilot Study of a Brief Mind-Body Bridging Intervention for Suicidal Ideation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Salt Lake City Health Care System
Collaborators
Mind Body Bridging Charity

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Mind Body Bridging
Keywords
mind body bridging, mindfulness, suicidal ideation, suicide related behaviors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment As Usual with Mind-Body Bridging (TAU + MBB)
Arm Type
Experimental
Arm Description
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 four, 90-minute Mind Body Bridging group sessions that will occur for four weeks in a row. Each group will involve up to 15 participants and will be led by a trained MBB facilitator.
Intervention Type
Behavioral
Intervention Name(s)
Mind Body Bridging Group Session
Intervention Description
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 four, 90-minute Mind Body Bridging group sessions that will occur for four weeks in a row. Each group will involve up to 15 participants and 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.
Primary Outcome Measure Information:
Title
Change in frequency and/or intensity of suicidal ideation
Description
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.
Time Frame
Weekly during the intervention, one-month post-intervention, three months post-intervention, six months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be Veterans aged 18-70 with psychiatric and/or addictive disorders who are on the High Risk Suicide List because of suicidal ideations and/or behaviors. Exclusion Criteria: Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Don Glover, PhD
Phone
8015821565
Ext
2325
Email
don.glover@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Vasa, LCSW
Phone
8015821565
Email
jessica.vasa@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Glover, PhD
Organizational Affiliation
VA Salt Lake City HCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
George E. Wahlen Department of Veterans Affairs Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Don Glover, PhD
Phone
801-558-1565
Ext
2325
Email
don.glover@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Brief Mind-Body Bridging Intervention for Suicidal Ideation

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