Veterans Coping Long-term With Active Suicide

Study Overview
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Brief Summary
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The proposed study seeks to test the efficacy of an intervention to reduce suicide behaviors in Veterans. The Veterans Coping Long Term with Active Suicide Program (CLASP-VA) is an innovative, telephone-based intervention that combines elements of individual therapy, case management, and significant other/family therapy and is designed to be integrated into a VA system.

Detailed Description
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Suicide is a leading cause of death for military personnel, and for the first time in recorded history, rates of military suicides are exceeding civilian rates. Despite public and patient health costs associated with suicidal ideation and behavior, existing efforts haven't appreciably reduced rates of suicidal behavior in the military. Consequently, finding novel, efficacious, and acceptable methods to reduce suicide behaviors is imperative. The Veteran's Coping Long Term with Active Suicide Program (CLASP-VA) is a unique suicide reduction intervention that directly targets high-risk patients at the time of hospital discharge. It is one of the few empirically-developed and promising interventions (e.g., strong pilot data) for individuals hospitalized for suicide behavior. The primary objective of this study is to test the efficacy of the CLASP intervention compared to a treatment as usual plus Safety Assessment and Follow-up Evaluation (SAFE) control condition. Efficacy will be determined by primary outcomes including: number of attempts, number of re-hospitalizations, severity, and chronicity of suicidal ideation. A secondary objective is identifying the types of patients who receive the most benefit from the CLASP-VA intervention.

Official Title
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Veterans Coping Long-Term With Suicide

Conditions
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Suicide

Intervention / Treatment
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* Behavioral: Coping Long Term with Active Suicide (CLASP)
* Other: Safety Assessment and Follow Up Evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suicide attempt or suicidal ideation with any methods, plan, and/or intent to make a suicide attempt within 1 week of hospitalization age greater than 18 have a telephone ability to speak, read, and understand spoken English sufficiently well to complete the procedures of the study Exclusion Criteria: long-term psychiatric disorder diagnosis of borderline personality disorder cognitive impairment which would interfere with adequate participation in the project (MMSE <20)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLASP Intervention<br>A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other. | Behavioral: Coping Long Term with Active Suicide (CLASP)<br>* 6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management<br>Other: Safety Assessment and Follow Up Evaluation<br>* enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider<br>|
| Other: Safety Assessment and follow up Evaluation<br>Treatment as usual plus enhanced monitoring. | Other: Safety Assessment and Follow Up Evaluation<br>* enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | Items measuring attempt behavior (number of Actual Attempts, number of Aborted Attempts, number of Interrupted Attempts) From the Columbia Suicide Severity Rating Scale were summed to create a composite variable indexing attempt behavior. Higher scores indicate more attempt behavior. We log transformed this variable at all time points to meet assumptions of normality. | baseline, 3, 6, 9, & 12 month post-hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Beck Hopelessness Scale | The Beck Hopelessness Scale was used to measure changes in hopelessness from baseline to 12-month followup. Items are dichotomous (0: False and 1: True), with a total score ranging from 0-20. Higher scores indicate greater hopelessness. | Baseline, 3, 6, 9, & 12 month follow up | 
| Brief Symptom Inventory | The Brief Symptom Inventory is a validated, self-reported instrument assessing current psychiatric symptomatology. Possible scores for each item range from 0 (not at all) to 4 (extremely), and total scores are represented by a Global Severity Index (range 0 to 212).Higher scores indicate greater psychological distress. | Baseline, 3, 6, 9, & 12 month follow up | 
| World Health Organization Disability Assessment Schedule (WHODAS) II | The World Health Organization Disability Assessment Schedule (WHODAS II) is a validated, self-reported instrument assessing current impairment in functioning. Possible scores for each item range from 1 (None) to 5 (Extreme or cannot do). We calculated an Average Global Score for inclusion in analyses by dividing the total score by the number of items included in the measure (possible range of 1-5). Higher scores indicate greater impairment in functioning. We examined changes in overall functioning from baseline in these analyses. | Baseline, 3, 6, 9, & 12 month follow ups | 
| Treatment History Interview | We used an item measuring psychiatric hospitalizations from the Treatment History Interview to measure treatment utilization. Study participants indicated how many times they had been psychiatrically hospitalized since the prior study timepoint. We log transformed this variable at each timepoint to meet statistical assumptions of normality for our analyses. | 3, 6, 9, & 12 month follow up | 
| Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | Intensity of ideation was measured using the Columbia Scale for Suicide Ideation intensity of ideation item. Item responses range from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating more severe ideation. Minimum score on the ideation measure is 1 and maximum score is 5. | baseline, 3, 6, 9, & 12 month post-hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, prevention, Veterans health