NCT04084756

Brief Summary

Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment. The study's objectives are to test the effect of the CCRP, a targeted single session couples intervention on suicide ideation among military service members and Veterans, and to understand how the use of the CCRP impacts suicide risk during the 6 months immediately postdischarge from a psychiatric inpatient unit.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

September 3, 2019

Last Update Submit

May 10, 2022

Conditions

Suicide

Outcome Measures

Primary Outcomes (1)

  • Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation

    Self-report assessment of severity of suicidal thoughts and behaviors. Items 1-19 are summed (range: 0-38) and higher scores indicate greater suicide severity. Measured at baseline, hospital discharge, and 1, 3, and 6 month follow ups.

    Assessed at baseline and 1, 3 and 6-months follow ups

Secondary Outcomes (1)

  • Change in number of suicide attempts from baseline

    Assessed at baseline and 1, 3 and 6-months follow ups

Study Arms (2)

Couples Crisis Response Plan

EXPERIMENTAL
Behavioral: Couples Crisis Response Plan

Mental Health Education

ACTIVE COMPARATOR
Behavioral: Mental Health Education

Interventions

Couples Crisis Response PlanBEHAVIORAL

The CCRP is a single session therapist-facilitated suicide prevention intervention conducted with a dyad

Couples Crisis Response Plan
Mental Health EducationBEHAVIORAL

The Mental Health Education session is a single session therapist-facilitated mental health psychoeducation session conducted with a dyad

Mental Health Education

Eligibility Criteria

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

You may qualify if:

  • military service member (active duty or veteran) of any branch or component that has served since 9/11/2001 or the partner of such a service member;
  • that the service member reports active suicide ideation and/or a suicide attempt within the previous 30 days;
  • that the service member is in a committed, exclusive, cohabiting relationship of at least 6 months;
  • the willingness of the service member's partner to participate in research.

You may not qualify if:

  • a psychiatric condition, medical condition, or cognitive disability/deficit that precludes the ability of either partner to provide informed consent
  • physical aggression within the past year reported by either partner on a behaviorally-anchored screener for moderate to severe partner violence or extreme relationship distress (a score of of less than 9 on the Couples Satisfaction Index-4)
  • inability of either partner to read or speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salt Lake Behavioral Health

Salt Lake City, Utah, 84111, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Alexis May, PhD

    Wesleyan Univerity

    PRINCIPAL INVESTIGATOR

  • Craig Bryan, PsyD, APBB

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 10, 2019

Study Start

August 1, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

US(1)