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SuicideNCT02462694

High Risk Suicidal Behavior in Veterans

A study testing Dialectical Behavior Therapy and Treatment As Usual in people with Suicide, run by Bronx Veterans Medical Research Foundation, Inc.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Suicide
What is being tested?
Dialectical Behavior Therapy and Treatment As Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
No sites listed yet
Study dates
Apr 2010to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

Official title: High Risk Suicidal Behavior in Veterans - Assessment of Predictors and Efficacy of Dialectical Behavior Therapy

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.

Read the 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.

Conditions
Suicide
Being tested
Dialectical Behavior Therapy, Treatment As Usual
Medical subject headings
Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior TherapyBehavioural

    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

  • Treatment As UsualBehavioural

    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

Study groups in NCT02462694
Study groupRoleWhat they receive
Treatment as UsualActive comparatorTreatment as usual (TAU): Standard psychological, psychopharmacology and case management services
Receives: Behavioral: Treatment As Usual
Dialectical Behavior TherapyExperimentalStandard Dialectical Behavior Therapy (DBT): weekly individual sessions, skills training group and telephone coaching as needed
Receives: Behavioral: Dialectical Behavior Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Counting of suicidal events

    Utilizing the The Columbia Suicide Severity Rating Scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startApr 2010
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462694
Sponsor's protocol ID
GOO-09-073
Status last verified
Jan 2018
First submitted
2 Jun 2015
Last updated
18 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27780335

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavior Therapy and Treatment As Usual in people with Suicide, run by Bronx Veterans Medical Research Foundation, Inc.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Counting of suicidal events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02462694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.

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