Veterans Coping Long-term With Active Suicide

Suicide Clinical Trial

— CLASP-VA  

Official title:

Veterans Coping Long-Term With Suicide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894841
• Other study ID #: IIR 13-026
• Status: Completed
• Phase: N/A
• Start date: February 24, 2014
• Est. completion date: August 29, 2018

Study information

• Verified date: January 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Coping Long Term with Active Suicide (CLASP)
6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management

Other:
• Safety Assessment and Follow Up Evaluation
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

Locations

Country	Name	City	State
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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