Couple-Based Crisis Safety Planning (CRP-C)

University of Georgia (UGA)

Status: Not yet enrolling

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

Treatments: Behavioral: Crisis Response Planning; Behavioral: Couples-based Crisis Response Planning

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07012824

HT94252410658 (Other Grant/Funding Number)

PROJECT00009562

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Traditional Crisis Response Planning

Active Comparator group

Description:

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.

Treatment:

Behavioral: Crisis Response Planning

Couples-based Crisis Response Planning

Experimental group

Description:

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.

Treatment:

Behavioral: Couples-based Crisis Response Planning