Clinical trial NCT07012824: Couple-Based Crisis Safety Planning
Official title: Couple-Based Crisis Response Planning for Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2025-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: This study is a pilot randomized controlled trial of a novel, virtually-delivered, single- session Couple-Based Crisis Response Plan (CRP-C) to reduce suicide crisis symptoms and decrease suicide risk in a community-based Veteran sample in Georgia. Crisis response planning (CRP; also referred to as "Safety Planning") 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. CRP has been shown to be effective at reducing suicidal behaviors. A strong line of research shows that a relationship with an intimate partner (e.g., a spouse) is often a major protective factor for preventing suicide risk. Further, partners are often the only (and last) people Veterans talk about suicidal thoughts with. Despite this, clinicians do not have any brief interventions (like CRP) that leverage the partner relationship to make the intervention more effective. In addition, past work has heavily focused on providing CRP to Veterans who have disclosed suicide risk. However, investigators know that many Veterans do not disclose risk at all and do not seek out treatment for suicidal thoughts because of stigma. It may be more beneficial to give CRP to Veterans who exhibit less-stigmatized symptoms that are strongly associated with suicide risk (e.g., sharp increases in agitation, insomnia, irritability, etc.) but who may not yet have developed suicidal ideation or are unwilling to disclose suicidal ideation. This approach may provide more Veterans and their partners with the skills needed to navigate a suicidal crisis and prevent suicide attempts/deaths.

This project will test the efficacy of a virtually-delivered, single-session Couple-Based Crisis Response Plan (CRP-C) in decreasing suicide crisis symptoms in a community-based Veteran sample compared to standard (individual) Crisis Response Planning (CRP). The investigators will enroll 50 couples where at least one of the partners is a Veteran. Couples will be randomized to receive traditional CRP or CRP-C via a virtual, one-time session. The CRP-C is comprised of the same components as traditional CRP, but with several key additions: 1) The partner also completes the CRP-C on behalf of the Veteran; 2) CRP-C contains an additional section that includes practical steps for broaching crisis-related conversations with the partner (i.e., helpful/unhelpful language, helpful/unhelpful actions, alterations for severe crises); 3) After completing the CRP-C independently, the Veteran and partner compare responses to increase awareness for both parties and allow the partner to offer additional suggestions and ask clarifying questions. Veterans will be surveyed 3x per day for thirty days to assess fluctuations of crisis symptoms and suicide risk, and complete a 3-month follow-up assessment. The investigators will test two advertisements (recruiting for crisis symptoms, recruiting for suicide risk) for the same study to test recruitment strategy effects on recruitment outcomes.

Our main aims are to:

1. Investigate the acceptability and feasibility of CRP-C
2. Test the effects of CRP-C on reducing crisis symptoms
3. Examine the effect of recruitment strategies on recruitment rates.

To achieve the study's primary aim (gather feasibility and acceptability data), the investigators chose a two-arm, repeated measures approach to quantitatively examine the intervention.The investigators will compare feasibility and acceptability with traditional CRP, as CRP is the current standard of care for the VA, medical centers, and many outpatient clinics for patients at increased risk for suicide. Given that CRP-C is ultimately meant to decrease STBs, it is critical to examine if adverse events and tolerability are similar in the two approaches to ensure safety of future participants and their partners. Due to the highly dynamic nature of suicidal crises, STBs, and STB risk factors, the investigators will use EMA methodology for higher temporal resolution to help understand potential effects of CRP-C.

Given the difficulty of engaging Veterans with suicide prevention interventions, the investigators will also test if recruiting based on non-stigmatized crisis symptoms leads to increased enrollment compared to recruiting to reduce STBs. Throughout, the investigators will also use qualitative methods to obtain a deeper understanding of how to tailor the intervention to couples in the Veteran population and help identify contextual aspects implementing the CRP-C that will not be measured during the pilot but would be assessed in the subsequent trial. Qualitative feedback will also help guide interpretation and application of the quantitative findings and provide additional information on intervention fidelity.

Specific Aim 1: Gather feasibility and acceptability data

Specific Aim 2: Use EMA methodology for higher temporal resolution to help understand potential effects of CRP-C

Specific Aim 3: Test if recruiting based on non-stigmatized crisis symptoms leads to increased enrollment compared to recruiting to reduce suicidal thoughts and behaviors

Eligibility criteria: Inclusion Criteria:

* (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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Measured at 3-month follow-up appointment (Post-intervention)
measure: Feasibility Measure of Intervention (FIM)
timeFrame: Measured at 3-month follow-up appointment (Post-intervention)
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Measured at 3-month follow-up appointment (Post-intervention)
measure: Suicide Crisis Inventory-2
timeFrame: Measured during eligibility screening, baseline and at 3-month follow-up
measure: Recruitment Engagement
timeFrame: 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:
measure: The Couples Satisfaction Index (CSI)
timeFrame: Measured at baseline and at 3-month follow-up
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Measured at baseline and at 3-month follow-up
measure: Cognitive Flexibility Inventory (CFI)
timeFrame: Measured at baseline and at 3-month follow-up
measure: Theory of Planned Behavior Questionnaire (TPBQ)
timeFrame: Measured at baseline and at 3-month follow-up
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Measured at baseline and at 3-month follow-up
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
timeFrame: Administered one time during a 3-hour intervention session
measure: Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: Measured one time during a 3-hour intervention session
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured at baseline and at 3-month follow-up
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Measured at baseline and at 3-month follow-up
measure: Disability Assessment (WHODAS 2.0)
timeFrame: Measured at baseline and at 3-month follow-up
measure: DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
timeFrame: Measured at baseline and at 3-month follow-up
Other outcomes:
measure: Suicide Crisis Symptoms (SCS-2)
timeFrame: Measured 3 times a day for 30 days after intervention session
measure: Suicide Risk Assessment (DSI-SS)
timeFrame: Measured 3 times a day for 30 days after intervention session
measure: Crisis Response Planning Engagement
timeFrame: Measured 3 times a day for 30 days after intervention session
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Brian W. Bauer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: