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High Risk Suicidal Behavior in Veterans

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dialectical Behavior Therapy
Treatment As Usual
Sponsored by
Bronx Veterans Medical Research Foundation, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Veterans between the ages of 18 and 65
  2. Able to give consent
  3. Recent admission to psychiatric inpatient unit (6B)

Exclusion Criteria:

  1. Lifetime or current diagnosis of schizophrenia or other psychotic disorder; current psychosis from affective disorder
  2. IQ<80
  3. Current evidence or history of significant organic brain impairment, including stroke, CNS tumor, demyelinating disease, severe head trauma.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Treatment as Usual

    Dialectical Behavior Therapy

    Arm Description

    Treatment as usual (TAU): Standard psychological, psychopharmacology and case management services

    Standard Dialectical Behavior Therapy (DBT): weekly individual sessions, skills training group and telephone coaching as needed

    Outcomes

    Primary Outcome Measures

    Counting of suicidal events
    Utilizing the The Columbia Suicide Severity Rating Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2015
    Last Updated
    January 16, 2018
    Sponsor
    Bronx Veterans Medical Research Foundation, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02462694
    Brief Title
    High Risk Suicidal Behavior in Veterans
    Official Title
    High Risk Suicidal Behavior in Veterans - Assessment of Predictors and Efficacy of Dialectical Behavior Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bronx Veterans Medical Research Foundation, Inc

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Suicide is a pressing problem in the US military, with evidence of increased risk for suicide particularly among soldiers serving in Iraq and Afghanistan. To date, there are very few studies that empirically evaluate treatment efficacy to prevent suicide. One treatment that has been shown empirically to decrease suicidal behavior is Dialectical Behavioral Therapy (DBT), although these studies have been limited to patients with borderline personality disorder (BPD). The current proposal aims to examine the efficacy of DBT in reducing suicidal behavior more broadly in a diagnostically heterogeneous group of veterans with high risk suicidal behavior. One of the difficulties in doing research in suicide prevention is that serious suicidal behavior is a relatively rare event, and alone is not a satisfactory target for treatment studies. It is extremely important, therefore, to identify intermediate symptoms that are closely associated with high risk suicidal behaviors, as targets for treatment. One critical area our proposal addresses is validating new treatment models for suicide in veterans; DBT has been empirically validated to reduce suicidal behavior in individuals with BPD, but has not been tested more broadly to target suicidal behaviors. The second critical area which our proposal addresses is exploring new suicide risk assessment measures. While the investigators do not specifically propose to develop new screening tools, the investigators do propose to identify potentially important domains that specifically differentiate ill high risk suicide veterans from low risk. This information will be useful in future efforts to modify the DBT approach to be more effective for the broader diagnostic group of high risk suicidal veterans.
    Detailed Description
    This project proposes two related studies. The first project is a randomized clinical trial of 120 veterans identified with high-risk suicidal behavior comparing the efficacy of DBT vs. treatment as usual (TAU) on suicidal behavior as a primary outcome measure. A second aim of the present project is to examine group differences between 200 300 veterans at high risk for suicide and 200 veterans at low risk in a variety of symptom domains. The goal of this will be to identify symptoms associated with suicidal behavior that can be used as secondary and exploratory outcome measures for DBT. The investigators will assess symptom domains including mood and substance use that have been associated with suicidal behavior by previous research and validate those in our veteran population by comparing symptoms in low vs. high risk veterans recently discharged from the James J Peters VAMC (JJPVA) psychiatric inpatient unit. In addition, the investigators will explore indices of interpersonal function and measure features that have some evidence of offering protection from suicide, which could be viewed as resilience factors. A particular emphasis of the present project is to characterize the nature of the interpersonal dysfunction in high risk individuals, as there exists very good evidence that social isolation, or a lack of a sense of "belonging" puts people at particularly high risk for suicide, in particular in a military sample. The investigators intend to assess the impact of DBT vs. TAU on these symptom domains in addition to their impact on suicidal behavior. The subject population for both projects will be veterans identified on a "high risk" suicide list at the James J. Peters VAMC; veterans are so identified by the suicide coordinator because of a recent inpatient hospitalization involving high-risk suicidal behavior. Priority will be given to OEF/OIF veterans. In order to identify symptoms associated with high risk suicidal behavior, the investigators will examine symptoms domains in our high risk subjects and contrast them with a comparison group of veterans recently discharged from the psychiatric inpatient service or treated in the outpatient mental health department at the James J Peters VA Medical Center with no history of high-risk suicidal behaviors (low risk veterans). Groups will be matched with respect to age and gender. For this project, the investigators will include veterans with a variety of diagnoses, including post-traumatic stress disorder (PTSD), substance abuse, affective disorders, personality disorders, and anxiety disorders. The investigators will exclude subjects with current psychosis or cognitive impairment as these symptoms would prevent appropriate engagement in DBT. Patients from the high-risk suicide list will be eligible to participate in a six month DBT treatment study and will be randomized to full DBT vs. TAU. Both groups will have psychopharmacological management by their outpatient psychiatrist and be able to participate in standard ancillary outpatient clinical offerings (e.g. AA, sleep group). Both treatment groups will be assessed at baseline, at the 6 month treatment completion mark, as well as follow-up time points including one year and eighteen months after enrollment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    91 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    Treatment as usual (TAU): Standard psychological, psychopharmacology and case management services
    Arm Title
    Dialectical Behavior Therapy
    Arm Type
    Experimental
    Arm Description
    Standard Dialectical Behavior Therapy (DBT): weekly individual sessions, skills training group and telephone coaching as needed
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dialectical Behavior Therapy
    Intervention Description
    Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment As Usual
    Intervention Description
    TAU for these subjects involves close tracking by the Suicide Prevention Coordinator and treatment by their individual team of clinicians. Additionally, a support group with psychoeducation about suicide prevention will be offered as part of TAU
    Primary Outcome Measure Information:
    Title
    Counting of suicidal events
    Description
    Utilizing the The Columbia Suicide Severity Rating Scale
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Veterans between the ages of 18 and 65 Able to give consent Recent admission to psychiatric inpatient unit (6B) Exclusion Criteria: Lifetime or current diagnosis of schizophrenia or other psychotic disorder; current psychosis from affective disorder IQ<80 Current evidence or history of significant organic brain impairment, including stroke, CNS tumor, demyelinating disease, severe head trauma.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marianne Goodman, MD
    Organizational Affiliation
    James J. Peters Veterans Affairs Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27780335
    Citation
    Goodman M, Banthin D, Blair NJ, Mascitelli KA, Wilsnack J, Chen J, Messenger JW, Perez-Rodriguez MM, Triebwasser J, Koenigsberg HW, Goetz RR, Hazlett EA, New AS. A Randomized Trial of Dialectical Behavior Therapy in High-Risk Suicidal Veterans. J Clin Psychiatry. 2016 Dec;77(12):e1591-e1600. doi: 10.4088/JCP.15m10235.
    Results Reference
    derived

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    High Risk Suicidal Behavior in Veterans

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