Couple-Based Crisis Safety Planning

NCT07012824 | Not Yet Recruiting DMC

• 2 other identifiers: PROJECT00009562HT94252410658
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide is a leading cause of death in Veterans. Suicide rates among Veterans have increased approximately 36% from 2001 to 2020. Veterans are at increased risk for suicide compared to non-Veterans, with the rate of suicide death being 57.3% higher for Veterans than non-Veterans. The present study will pilot test a virtual couple-based crisis response plan (CRP-C) for Veterans in order to reduce crisis symptoms and decrease suicide risk.

Conditions

Suicidal Ideas; Suicidal Ideation; Crisis; Emotional; Suicide Attempts; Suicidal and Self-injurious Behaviour; Suicidal Impulses

Keywords

Veteran safety; Suicide risk; Crisis safety plan; Suicide crisis; intervention

Outcome Measures

Primary Outcomes (5)

• Acceptability of Intervention Measure (AIM)

  Higher scores indicate greater acceptability of the present intervention. The minimum score is 4 and the maximum possible score is 20.

  Measured at 3-month follow-up appointment (Post-intervention)

• Feasibility Measure of Intervention (FIM)

  Higher scores indicate greater feasibility of the present intervention. The minimum score is 4 and the maximum possible score is 20.

  Measured at 3-month follow-up appointment (Post-intervention)

• Intervention Appropriateness Measure (IAM)

  Higher scores indicate greater appropriateness of the present intervention. The minimum possible score is 4 and the maximum possible score is 20.

  Measured at 3-month follow-up appointment (Post-intervention)

• Suicide Crisis Inventory-2

  Suicide crisis symptoms will be assessed using a short form version of the Suicide Crisis Inventory - 2 (SCI-2) during eligibility screener. The SCI-2-SF is a 9-item self-report measure that assesses crisis symptoms over the past several days across five subscales: 1) Entrapment; 2) Affective Disturbance; 3) Loss of Cognitive Control; 4) Hyperarousal; and 5) Social Withdrawal, with selected items recorded such that higher scores are indicative of more severe SCS symptoms. The full 61-item measure will be utilized in later stages of data collection (i.e. baseline assessment and 3-month follow-up assessment). The maximum total score for the short form version is 36. The maximum total score for the standard 61-item version of the measure is 244. Minimum possible scores for both versions of the scale are 0.

  Measured during eligibility screening, baseline and at 3-month follow-up

• Recruitment Engagement

  Once the desired participant quota (50 couples) is met, the study team will analyze the means by which participants were recruited. This study utilizes two different advertisements that describe the same study, but with different language. The study team will assess which type of advertisement yielded more engagement, once all participants are enrolled.

  Monitored throughout enrollment phase (i.e. from start of enrollment until participant quota is met). This will occur over approximately a 3-month time frame. This data will be analyzed along with other outcomes after data collection has concluded.

Secondary Outcomes (11)

• The Couples Satisfaction Index (CSI)

  Measured at baseline and at 3-month follow-up

• Difficulties in Emotion Regulation Scale (DERS)

  Measured at baseline and at 3-month follow-up

• Cognitive Flexibility Inventory (CFI)

  Measured at baseline and at 3-month follow-up

• Theory of Planned Behavior Questionnaire (TPBQ)

  Measured at baseline and at 3-month follow-up

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Measured at baseline and at 3-month follow-up

Other Outcomes (3)

• Suicide Crisis Symptoms (SCS-2)

  Measured 3 times a day for 30 days after intervention session

• Suicide Risk Assessment (DSI-SS)

  Measured 3 times a day for 30 days after intervention session

• Crisis Response Planning Engagement

  Measured 3 times a day for 30 days after intervention session

Study Arms (2)

Traditional Crisis Response Planning

ACTIVE COMPARATOR

This arm will utilize the traditional Crisis Response Plan protocol. This arm will not utilize the help of a romantic partner in creating a crisis safety plan for the participating Veteran.

Behavioral: Crisis Response Planning

Couples-based Crisis Response Planning

EXPERIMENTAL

This arm will utilize Couples-based Crisis Response Planning. This method of intervention involves the participation of the romantic partner of a Veteran who is receiving the intervention.

Behavioral: Couples-based Crisis Response Planning

Interventions

Crisis Response Planning BEHAVIORAL

Crisis Response Planning (CRP) is a brief, one-time intervention that teaches individuals to notice warning signs of an impending crisis (e.g., suicidal crisis) and provide them with skills to help reduce suicide risk.

Also known as: Safety Planning, CRP

Traditional Crisis Response Planning

Couples-based Crisis Response Planning BEHAVIORAL

This intervention expands on traditional CRP by integrating the intimate partner into the intervention. Among service members, intimate partners are the group most likely to be told about suicidal thoughts prior to a suicide attempt.

Also known as: CRP-C

Couples-based Crisis Response Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (At least) One participant from the couple must have Veteran status
• Currently resides in Georgia
• English speaking
• The Veteran must own a smartphone
• Veteran must have experienced crisis symptoms in the past three months. At least 1 symptom of entrapment, and at least 1 symptom from 2 of the associated disturbance categories \[i.e. affective disturbance, loss of cognitive control, hyperarousal, or social withdrawal\]
• Currently be in a committed relationship for at least one year
• The Veteran must be able to present a copy of DD form 214 (Certificate of Release or Discharge from Active Duty issued by the U.S. Department of Defense)

You may not qualify if:

• Non-English speaking
• Under 18 years of age
• Resides in a different state than Georgia
• Either partner reports injury or fear resulting from intimate partner violence in the past three months.
• Participants who meet study criteria for imminent suicide risk Depressive Symptom Index - Suicidality Subscale (Joiner et al., 2002), defined as a DSI- SS score of 7 or greater, or selecting "3" on items B \[formulated plan\] or D \[constant urge to kill self (I. H. Stanley et al., 2021)

Sponsors & Collaborators

• University of Georgia: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Georgia

Athens, Georgia, 30601, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Study Officials

• Brian W. Bauer, Ph.D.

  University of Georgia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Coordinator

CONTACT

404-402-7153; gss28053@uga.edu

Partnering Principal Investigator

CONTACT

(706) 542-1173; lavner@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be assigned to one of two conditions: (1) CRP (control) where a Veteran will undergo the traditional CRP intervention, without the help participation of a romantic partner, and (2) CRC-P, where couples with at least one Veteran in the relationship will work together to complete the CRP-C intervention.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

US (1)