Veterans Coping Long-term With Active Suicide (CLASP-VA)

January 28, 2020 updated by: VA Office of Research and Development

Veterans Coping Long-Term With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Providence VA Medical Center, Providence, RI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CLASP Intervention
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)
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
Other: Safety Assessment and follow up Evaluation
Treatment as usual plus enhanced monitoring.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 3, 6, 9, & 12 month post-hospitalization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3, 6, 9, & 12 month follow up
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.
Baseline, 3, 6, 9, & 12 month follow up
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.
Baseline, 3, 6, 9, & 12 month follow ups
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.
3, 6, 9, & 12 month follow up
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.
baseline, 3, 6, 9, & 12 month post-hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Butler Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIR 13-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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