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Suicidal IdeasCRP-CNCT07012824

Couple-Based Crisis Safety Planning

A study testing Crisis Response Planning and Couples-based Crisis Response Planning in people with Suicidal Ideas and Suicidal Ideation, run by University of Georgia at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Crisis Response Planning and Couples-based Crisis Response Planning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Jun 2025to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • (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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Project Coordinator contact

404-402-7153

gss28053@uga.edu

Partnering Principal Investigator contact

(706) 542-1173

lavner@uga.edu

United States1 site
  • University of Georgia

    Athens, Georgia, 30601

    Garrett S Smith, Psychology B.S., 4044027153, gss28053@uga.edu

    Brian W. Bauer, Ph.D., (706) 542-3012, brian.bauer@uga.edu

Other trials in United States

About this study

Official title: Couple-Based Crisis Response Planning for Veterans

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.

Read the 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

Being tested
Crisis Response Planning, Couples-based Crisis Response Planning
Keywords
Veteran safety, Suicide risk, Crisis safety plan, Suicide crisis, intervention
Medical subject headings
Suicidal Ideation, Suicide, Attempted, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crisis Response PlanningBehavioural

    Also called Safety Planning, CRP

    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.

  • Couples-based Crisis Response PlanningBehavioural

    Also called CRP-C

    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.

Study groups in NCT07012824
Study groupRoleWhat they receive
Traditional Crisis Response PlanningActive comparatorThis 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.
Receives: Behavioral: Crisis Response Planning
Couples-based Crisis Response PlanningExperimentalThis 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.
Receives: Behavioral: Couples-based Crisis Response Planning

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

  5. 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.

    Measured: 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)
  1. The Couples Satisfaction Index (CSI)

    Relationship quality will be assessed using the Couples Satisfaction Index. The CSI is a widely-used and well-validated 32-item self-report measure that assesses relationship quality, and has been used for psychosocial interventions for military couples. Higher scores indicate greater satisfaction with one's relationship. The maximum total score for this scale is 161. The minimum possible score is 0.

    Measured: Measured at baseline and at 3-month follow-up

  2. Difficulties in Emotion Regulation Scale (DERS)

    Emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale. The DERS is a widely-used 36-item self-report measure that assesses emotion dysregulation and six subfactors: 1) Awareness; 2) Clarity; 3) Goals; 4) Impulse; 5) Non-Acceptance; and 6) Strategies. The measure is well-validated and has been used extensively in Veteran and military samples. Higher scores suggest greater problems with emotion regulation. The maximum possible total score is 180. The minimum possible total score is 36.

    Measured: Measured at baseline and at 3-month follow-up

  3. Cognitive Flexibility Inventory (CFI)

    Cognitive flexibility will be assessed using the Cognitive Flexibility Inventory. The CFI is a well-validated 20-item self-report measure that measures three aspects of cognitive flexibility: 1) Controllability Perception; 2) Alternative Explanation Awareness; and 3) Alternative Solution Generation. The maximum possible score on this scale is 140, and the minimum possible score is 20, with higher scores indicating greater cognitive flexibility.

    Measured: Measured at baseline and at 3-month follow-up

  4. Theory of Planned Behavior Questionnaire (TPBQ)

    Behavioral intention will be assessed using a Theory of Planned Behavior Questionnaire (TPBQ). The TPBQ is a 9-item version of the scale that was developed using the guidelines set forth by Ajzen (2006) and measures: 1) Attitude Toward Behavior; 2) Injunctive and Descriptive Norms; 3) Perceived Behavioral Control; 4) Intention; and 5) Past Behaviors. The scale was modified to fit the scope of the intervention that takes place in the study (i.e. Crisis Response Planning) This scale is scored in 5 different dimensions with a maximum total score of 63 and a minimum possible total score of 9.

    Measured: Measured at baseline and at 3-month follow-up

  5. Center for Epidemiologic Studies Depression Scale (CES-D)

    A self-report depression scale for research in the general population. Scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression.

    Measured: Measured at baseline and at 3-month follow-up

  6. Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

    The Diagnostic Interview for Anxiety, Mood, and ObsessiveCompulsive and Related Neuropsychiatric Disorders will be used to assess current and lifetime histories of mental disorders to characterize the sample. This is necessary to understand the clinical severity of our sample in relation to previous CRP studies to guide interpretations for generalizability. The DIAMOND is a well-validated and widely-used semi-structured interview designed to assess for DSM-5 diagnoses. Screener questions and follow-up modules will be administered for the following disorders: Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Persistent Depressive Disorder, Major Depressive Disorder, Bipolar I \& II Disorders, Obsessive-Compulsive Disorders, Acute Stress Disorder, Post-traumatic Stress Disorder, Adjustment Disorder, Substance Use Disorder, and Attention Deficit/Hyperactivity Disorder.

    Measured: Administered one time during a 3-hour intervention session

  7. Columbia Suicide Severity Rating Scale (CSSRS)

    This protocol includes two subscales from the Screening version of the Columbia-Suicide Severity Rating Scale © (C-SSRS): Severity of Suicidal Ideation and Suicidal Behavior. Both subscales provide definitions of suicidal ideation and behavior and corresponding probes. The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal, self-injurious behavior.

    The Current version of the C-SSRS assesses suicidality during a two time periods-ideation in the past month and suicidal behavior in the past 3 months.

    Measured: Measured one time during a 3-hour intervention session

  8. Patient Health Questionnaire (PHQ-9)

    Depressive symptoms will be measured by the Patient Health Questionnaire-9. The PHQ-9 is a widely used 9- item self-report measure that assesses depressive symptoms over the past two weeks. The maximum possible score is 27 and the minimum possible total score is 0, with higher scores indicating greater severity of depressive symptoms.

    Measured: Measured at baseline and at 3-month follow-up

  9. Generalized Anxiety Disorder Screener (GAD-7)

    Anxiety symptoms will be measured by the Generalized Anxiety Disorder - 7. The GAD-7 is a widely used 7-item self-report measure that asses anxious symptoms over the previous two weeks. The maximum possible score is 21 and the minimum possible total score is 0, with higher scores indicating greater severity of anxiety symptoms

    Measured: Measured at baseline and at 3-month follow-up

  10. Disability Assessment (WHODAS 2.0)

    The investigators will use the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) to assess health and disability. The WHODAS 2.0 is a 12-question self-report measure that covers six domains: 1) Cognition; 2) Mobility; 3) Self-care; 4) Getting Along; 5) Life Activities; and 6) Participation. The maximum possible converted summary score is 100 and the minimum score is 0, with higher scores indicating a greater level of disability.

    Measured: Measured at baseline and at 3-month follow-up

  11. DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult

    Assesses mental health domains across several psychiatric diagnoses. This measure consists of 23 questions and assesses 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Items ask individuals to rate how often they are bothered by symptoms in the last two weeks. A rating of mild (i.e., 2) or greater on any item within a domain (except for substance use, suicidal ideation, and psychosis) may serve as a guide for additional inquiry and follow up to determine if a more detailed assessment for that domain is necessary. For substance use, suicidal ideation, and psychosis, a rating of slight (i.e., 1) or greater on any item within the domain may serve as a guide for additional inquiry and follow-up to determine if a more detailed assessment is needed.

    Measured: Measured at baseline and at 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07012824
Sponsor's protocol ID
PROJECT00009562
Other IDs
HT94252410658
Acronym
CRP-C
Status last verified
Jun 2025
First submitted
8 May 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data from this study will be submitted to the National Institute of Mental Health (NIMH) Data Archive (NDA) at the National Institutes of Health (NIH)

Questions about this trial

What is this clinical trial studying?

A study testing Crisis Response Planning and Couples-based Crisis Response Planning in people with Suicidal Ideas and Suicidal Ideation, run by University of Georgia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Project Coordinator (404-402-7153, gss28053@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Intervention Measure (AIM) (time frame: Measured at 3-month follow-up appointment (Post-intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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