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Completed

NCT Number: NCT01894841

Veterans Coping Long-term With Active Suicide

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Depression Self-Injurious Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Coping Long Term with Active Suicide (CLASP)

Behavioral

6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management

Safety Assessment and Follow Up Evaluation

Other

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

Primary outcomes

  1. Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior

    Time frame: 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 outcomes

  1. Changes in Beck Hopelessness Scale

    Time frame: 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.

  2. Brief Symptom Inventory

    Time frame: 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.

  3. World Health Organization Disability Assessment Schedule (WHODAS) II

    Time frame: 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.

  4. Treatment History Interview

    Time frame: 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.

  5. Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Butler Hospital

Registry information

Official study title

Veterans Coping Long-Term With Suicide

Acronym: CLASP-VA

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2013
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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