Clinical trial NCT04084756: Couples Intervention to Improve Mental Health
Official title: Couples Intervention to Improve Mental Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Lead sponsor: Wesleyan University
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Military Suicide Research Consortium
First posted: 2019-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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, however no couple-bases suicide-specific interventions exist.

The study's objectives are to test the effect of the Couples Crisis Response Plan (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 period of time immediately post-discharge from a psychiatric inpatient unit. The CCRP will be compared to an active control condition (mental health education).

The primary aim is to compare the effect of the CCRP to an active control condition on suicide ideation in the 6 months following treatment among military service members and Veterans who have been psychiatrically hospitalized for acute suicide risk and their partners. The CCRP is specifically adapted for use with partnered service members at elevated risk for suicide. A secondary aim is to determine how use of the CCRP skills impacts suicidal ideation over time and identify the role partners play in encouraging use of the plan and managing suicide risk.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. that the service member reports active suicide ideation and/or a suicide attempt within the previous 30 days;
3. that the service member is in a committed, exclusive, cohabiting relationship of at least 6 months;
4. the willingness of the service member's partner to participate in research.

Exclusion Criteria:

1. a psychiatric condition, medical condition, or cognitive disability/deficit that precludes the ability of either partner to provide informed consent
2. 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)
3. inability of either partner to read or speak English

Primary outcomes:
measure: Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation
timeFrame: Assessed at baseline and 1, 3 and 6-months follow ups
Secondary outcomes:
measure: Change in number of suicide attempts from baseline
timeFrame: Assessed at baseline and 1, 3 and 6-months follow ups
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Salt Lake Behavioral Health
state: Utah
Study officials:
affiliation: Wesleyan Univerity
name: Alexis May, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Craig Bryan, PsyD, APBB
role: PRINCIPAL_INVESTIGATOR
References: