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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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 group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Treatment as usual (TAU): Standard psychological, psychopharmacology and case management services Receives: Behavioral: Treatment As Usual |
| Dialectical Behavior Therapy | Experimental | Standard 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.
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.
- First posted4 Jun 2015 (estimated)
- Study startApr 2010
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bronx Veterans Medical Research Foundation, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Goodman, Bronx Veterans Medical Research Foundation, Inc
- Investigators
- Marianne Goodman, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk Suicidal Behavior in Veterans - Assessment of Predictors and Efficacy of Dialectical Behavior Therapy
- ClinicalTrials.gov ID
- NCT02462694
- Acronym / sponsor ID
- GOO-09-073
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Bronx Veterans Medical Research Foundation, IncUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: Treatment As UsualTreatment as usual (TAU): Standard psychological, psychopharmacology and case management services |
| Dialectical Behavior Therapy | Experimental | Behavioral: Dialectical Behavior TherapyStandard Dialectical Behavior Therapy (DBT): weekly individual sessions, skills training group and telephone coaching as needed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans between the ages of 18 and 65
- Able to give consent
- Recent admission to psychiatric inpatient unit (6B)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior TherapyDialectical 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 | Behavioural | Dialectical Behavior Therapy |
| Treatment As UsualTAU 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 | Behavioural | Treatment as Usual |
Primary outcome
Counting of suicidal events
Time frame: 6 months
Utilizing the The Columbia Suicide Severity Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 27780335Goodman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Goodman, MD principal investigator
James J. Peters Veterans Affairs Medical Center
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.