Veterans Coping Long-term With Active Suicide

Not Applicable

Completed

• Conditions: Suicide
• Interventions: Other: Safety Assessment and Follow Up Evaluation; Behavioral: Coping Long Term with Active Suicide (CLASP)

• Registration Number: NCT01894841
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Study Start: 2014-02-24
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Results First Submitted: 2019-11-07
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Results First Posted: 2020-02-10
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Read More

Exclusion Criteria

• long-term psychiatric disorder
• diagnosis of borderline personality disorder
• cognitive impairment which would interfere with adequate participation in the project (MMSE <20)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safety Assessment and follow up Evaluation	Safety Assessment and Follow Up Evaluation	Treatment as usual plus enhanced monitoring.
CLASP Intervention	Safety Assessment and Follow Up Evaluation	A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
CLASP Intervention	Coping Long Term with Active Suicide (CLASP)	A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.

Primary Outcome Measures

Name	Time	Method
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior	baseline, 3, 6, 9, & 12 month post-hospitalization	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.

Secondary Outcome Measures

Name	Time	Method
Brief Symptom Inventory	Baseline, 3, 6, 9, & 12 month follow up	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.
Changes in Beck Hopelessness Scale	Baseline, 3, 6, 9, & 12 month follow up	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.
World Health Organization Disability Assessment Schedule (WHODAS) II	Baseline, 3, 6, 9, & 12 month follow ups	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.
Treatment History Interview	3, 6, 9, & 12 month follow up	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.
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity	baseline, 3, 6, 9, & 12 month post-hospitalization	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.

Trial Locations

Locations (1)

Providence VA Medical Center, Providence, RI; 🇺🇸 Providence, Rhode Island, United States