Couple-Based Crisis Safety Planning

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Georgia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

(At least) One participant from the couple must have Veteran status

Currently resides in Georgia

English speaking

The Veteran must own a smartphone

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Traditional Crisis Response PlanningActive comparator 1 intervention
Group B: Couples-based Crisis Response PlanningExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Measured at baseline and at 3-month follow-up

Other outcomes

1

Suicide Crisis Symptoms (SCS-2)

Suicide crisis symptoms will be measured using an abbreviated version of the SCS-2. Two to three items exhibiting the largest factor loadings for each of the five subfactors were extracted, resulting in 17 items. These items were then edited to be in the present tense ("Please indicate how you are feeling on the following items") and replaced with a visual analogue scale (0-100), which is similar to past EMA studies assessing suicide risk and associated variables. Higher scores indicate greater severity of crisis symptoms.

Time frame
Measured 3 times a day for 30 days after intervention session
2

Suicide Risk Assessment (DSI-SS)

Suicide risk will be assessed using the Depressive Symptom Index - Suicide Subscale (DSI-SS). This is a 4-item self-report measure that assesses current risk. Higher scores indicate greater levels of risk. The maximum possible total score for this scale is 12 and the minimum possible total score is 0

Time frame
Measured 3 times a day for 30 days after intervention session
3

Crisis Response Planning Engagement

Crisis response planning engagement will be assessed using nine binary ("Yes/No") self-report items to understand if participants did any of the following since their last survey: 1) Identify warning signs; 2) Internal coping strategies; 3) Activity based distractions; 4) Social distractions; 5) Location change; 6) Discuss thoughts with partner or others; 7) Contacted professionals; 8) Hospitalization; and 9) Lethal means safety. Higher scores indicate greater level of engagement with the current intervention

Time frame
Measured 3 times a day for 30 days after intervention session

Sponsors and contacts

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University of Georgia

Lead sponsor

United States Department of Defense

Collaborator

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