Overview

This trial is active, not recruiting.

Condition suicide
Treatments dialectical behavior therapy, treatment as usual
Sponsor Bronx Veterans Medical Research Foundation, Inc
Start date April 2010
End date December 2016
Trial size 500 participants
Trial identifier NCT02462694, GOO-09-073

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Treatment as usual (TAU): Standard psychological, psychopharmacology and case management services
treatment as usual
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
(Experimental)
Standard Dialectical Behavior Therapy (DBT): weekly individual sessions, skills training group and telephone coaching as needed
dialectical behavior therapy
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

Primary Outcomes

Measure
Counting of suicidal events
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title High Risk Suicidal Behavior in Veterans - Assessment of Predictors and Efficacy of Dialectical Behavior Therapy
Principal investigator Marianne Goodman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bronx Veterans Medical Research Foundation, Inc.