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Couples Intervention to Improve Mental Health

Primary Purpose

Suicide

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Couples Crisis Response Plan
Mental Health Education
Sponsored by
Wesleyan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

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

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

Sites / Locations

  • Salt Lake Behavioral Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Couples Crisis Response Plan

Mental Health Education

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 3, 2019
Last Updated
May 10, 2022
Sponsor
Wesleyan University
Collaborators
University of Utah, Military Suicide Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT04084756
Brief Title
Couples Intervention to Improve Mental Health
Official Title
Couples Intervention to Improve Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wesleyan University
Collaborators
University of Utah, Military Suicide Research Consortium

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Couples Crisis Response Plan
Arm Type
Experimental
Arm Title
Mental Health Education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Couples Crisis Response Plan
Intervention Description
The CCRP is a single session therapist-facilitated suicide prevention intervention conducted with a dyad
Intervention Type
Behavioral
Intervention Name(s)
Mental Health Education
Intervention Description
The Mental Health Education session is a single session therapist-facilitated mental health psychoeducation session conducted with a dyad
Primary Outcome Measure Information:
Title
Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation
Description
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.
Time Frame
Assessed at baseline and 1, 3 and 6-months follow ups
Secondary Outcome Measure Information:
Title
Change in number of suicide attempts from baseline
Description
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.
Time Frame
Assessed at baseline and 1, 3 and 6-months follow ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis May, PhD
Organizational Affiliation
Wesleyan Univerity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Bryan, PsyD, APBB
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salt Lake Behavioral Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84111
Country
United States

12. IPD Sharing Statement

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Couples Intervention to Improve Mental Health

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