NCT03677882

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 18, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

4.1 years

First QC Date

September 10, 2018

Last Update Submit

February 8, 2024

Conditions

Keywords

mind body bridgingmindfulnesssuicidal ideationsuicide related behaviors

Outcome Measures

Primary Outcomes (1)

  • 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.

    Weekly during the intervention, one-month post-intervention, three months post-intervention, six months post-intervention

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

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.

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

EXPERIMENTAL

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.

Behavioral: Mind Body Bridging Group Session

Interventions

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.

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • William Marchand, MD

    VA Salt Lake City HCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 19, 2018

Study Start

December 18, 2018

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations