Veterans Coping Long-term With Active Suicide (CLASP-VA)
Primary Purpose
Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Long Term with Active Suicide (CLASP)
Safety Assessment and Follow Up Evaluation
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring depression, prevention, Veterans health
Eligibility Criteria
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)
Sites / Locations
- Providence VA Medical Center, Providence, RI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
CLASP Intervention
Safety Assessment and follow up Evaluation
Arm Description
A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
Treatment as usual plus enhanced monitoring.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01894841
First Posted
July 3, 2013
Last Updated
January 28, 2020
Sponsor
VA Office of Research and Development
Collaborators
Butler Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01894841
Brief Title
Veterans Coping Long-term With Active Suicide
Acronym
CLASP-VA
Official Title
Veterans Coping Long-Term With Suicide
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 24, 2014 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Butler Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
depression, prevention, Veterans health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLASP Intervention
Arm Type
Experimental
Arm Description
A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
Arm Title
Safety Assessment and follow up Evaluation
Arm Type
Other
Arm Description
Treatment as usual plus enhanced monitoring.
Intervention Type
Behavioral
Intervention Name(s)
Coping Long Term with Active Suicide (CLASP)
Intervention Description
6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management
Intervention Type
Other
Intervention Name(s)
Safety Assessment and Follow Up Evaluation
Intervention Description
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 Outcome Measure Information:
Title
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior
Description
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.
Time Frame
baseline, 3, 6, 9, & 12 month post-hospitalization
Secondary Outcome Measure Information:
Title
Changes in Beck Hopelessness Scale
Description
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.
Time Frame
Baseline, 3, 6, 9, & 12 month follow up
Title
Brief Symptom Inventory
Description
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.
Time Frame
Baseline, 3, 6, 9, & 12 month follow up
Title
World Health Organization Disability Assessment Schedule (WHODAS) II
Description
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.
Time Frame
Baseline, 3, 6, 9, & 12 month follow ups
Title
Treatment History Interview
Description
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.
Time Frame
3, 6, 9, & 12 month follow up
Title
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity
Description
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.
Time Frame
baseline, 3, 6, 9, & 12 month post-hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Marie Primack, PhD MA
Organizational Affiliation
Providence VA Medical Center, Providence, RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Veterans Coping Long-term With Active Suicide
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