Couples Intervention to Improve Mental Health

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Couples Crisis Response Plan; Behavioral: Mental Health Education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84111
      • Salt Lake Behavioral Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Couples Crisis Response Plan	Behavioral: Couples Crisis Response Plan; The CCRP is a single session therapist-facilitated suicide prevention intervention conducted with a dyad
Active Comparator: Mental Health Education	Behavioral: Mental Health Education; The Mental Health Education session is a single session therapist-facilitated mental health psychoeducation session conducted with a dyad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of suicide attempts from baseline	The change in number of suicide attempts from baseline will be assessed through participants' responses to the Self-Injurious Thoughts and Behaviors Interview. The Self-Injurious Thoughts and Behaviors Interview is a structured interview assessing history of suicidal thoughts and behaviors, including suicide attempt history (dates, methods, and severity (e.g., need for medical attention) of previous suicide attempts). An increased number of suicide attempts at any assessment is considered a worse outcome.	Assessed at baseline and 1, 3 and 6-months follow ups

Collaborators and Investigators

• Sponsor: Wesleyan University
• Collaborators: University of Utah; Military Suicide Research Consortium
• Investigators: Principal Investigator: Alexis May, PhD, Wesleyan Univerity; Principal Investigator: Craig Bryan, PsyD, APBB, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: 00113793; W81XWH-16-2-0004 (Other Grant/Funding Number: Military Suicide Research Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No