Suicide, AttemptedNCT05000749
DBT Skills Groups for Veterans at High Risk for Suicide Attempt
A study testing DBT-SG and VHA treatment as usual in people with Suicide, Attempted, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
Veteran suicide death is a national crisis. Risk factors include emotion dysregulation, which occurs across mental health disorders. Dialectical behavior therapy (DBT) is an evidence-based suicide intervention that targets emotion dysregulation but is resource-intensive and not widely available at VHA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- DBT-SG and VHA treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Apr 2023to 26 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran eligible for VHA care at participating site
- two or more suicide attempts in lifetime, with one in past 12 months, on Columbia-Suicide Severity Rating Scale (C-SSRS)
- current suicidal ideation (endorsing a suicidal ideation scale of at least 1 [passive ideation] on C-SSRS
- emotion dysregulation (score 95 or greater on DERS)
- can attend group sessions
- willing to provide contact information for at least one person who can help locate the participant if study staff are unable to contact them (information for three contact persons will be requested; a participant must provide at least one contact person's information to be included in the study)
- access to telephone; if insufficient access to videoteleconference and local facility is using remote procedures for study, willing to request access to VA-provided device
Who cannot join
- significant cognitive impairment (score < 28 on modified Telephone Interview for Cognitive Status (mTICS)
- inability to read English or communicate in spoken and written English
- plan to move away or be unavailable in the next 18 months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Official title: A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt
Veteran suicide death is a national crisis. Risk factors include emotion dysregulation, which occurs across mental health disorders. Dialectical behavior therapy (DBT) is an evidence-based suicide intervention that targets emotion dysregulation but is resource-intensive and not widely available at VHA. A more efficient evidence-based DBT Skills Group (DBT-SG) is associated with reduced suicidal ideation and emotion dysregulation and likely more feasible to implement at VHA. This is a randomized controlled trial to test whether DBT-SG in addition to VHA treatment-as-usual, compared to only VHA treatment-as-usual, reduces Veteran emotion dysregulation.
Read the detailed description
This is a randomized controlled trial at four VHA medical centers. Veterans will be randomized to VHA treatment-as-usual or VHA treatment-as-usual plus DBT-SG.
- Conditions
- Suicide, Attempted
- Being tested
- DBT-SG, VHA treatment as usual
- Keywords
- suicide, attempted, dialectical behavior therapy, suicide attempt, emotion regulation
- Medical subject headings
- Suicide, Attempted, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-SGBehavioural
Dialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness.
VHA treatment as usualBehavioural
VHA treatment as usual for Veterans at risk for suicide attempt
| Study group | Role | What they receive |
|---|---|---|
| DBT-SG plus VHA treatment as usual | Experimental | Dialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness. Receives: Behavioral: DBT-SG; Behavioral: VHA treatment as usual |
| VHA treatment as usual | Active comparator | VHA treatment as usual for Veterans at risk for suicide attempt Receives: Behavioral: VHA treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotion dysregulation
Emotion dysregulation will be assessed with the Difficulties in Emotion Regulation Scale, a self-report measure. The scale ranges 36-180 with a higher score indicating greater difficulties in emotion regulation.
Measured: Up to18 month follow-up
Secondary outcomes (2)
Coping
Coping skills will be assessed with the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL), a self-report measure. The mean score ranges 0-3 with a higher score indicating greater use of coping strategies.
Measured: Up to 18 month follow-up
Columbia-Suicide Severity Rating Scale
The Columbia-Suicide Severity Rating Scale is a widely used interview measure of suicide risk. The number of suicide attempts during 18month follow-up will be reported (range 0 to infinity), with a higher score indicating more suicide attempts.
Measured: Up to 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start30 Apr 2023
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to one of two study conditions for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Suzanne Decker, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CTSteve Martino, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000749
- Sponsor's protocol ID
- SDR 20-136
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will include sensitive information about Veteran suicide risk. In consultation with the VACHS Research Office, the investigators elect not to share final data sets for this reason except as required under FOIA. Data will be preserved at VACHS on secure electronic servers behind the VA firewall, and made available for further study or validation by qualified individuals with VA IRB approval. Contact information for the corresponding mPI will be included in publications to facilitate such requests.
Publications
Decker SE, Kroll-Desrosiers A, Mattocks KM, Aunon FM, Galliford E, DeRycke EC, Doran N, Baird S, Rielage JK, Ridley J, Bannister J, Giovannelli TS, Fuehrlein BS, Shriver C, Spana E, Honsberger M, Demirelli SA, Shest E, Landes SJ, Goodman M, Martino S. Study protocol of a hybrid type 1 effectiveness-implementation multisite trial: Dialectical behavior therapy skills group for Veterans at high-risk for suicide attempt. Contemp Clin Trials. 2025 Apr;151:107828. doi: 10.1016/j.cct.2025.107828. Epub 2025 Feb 7.
PubMed 39923893Decker SE, Kroll-Desrosiers A, Mattocks K, Aunon FM, Galliford E, Doran N, Baird S, Rielage JK, Ridley J, Bannister J, Giovannelli TS, Landes SJ, Goodman M, Walker L, DeRycke E, Shriver C, Spana E, Honsberger M, Brown H, Demirelli S, Shest E, Martino S. Mixed-methods formative evaluation of implementing an adapted suicide prevention treatment: Dialectical Behavior Therapy Skills Groups in the Veterans Health Administration. Front Psychiatry. 2024 Nov 25;15:1495102. doi: 10.3389/fpsyt.2024.1495102. eCollection 2024.
PubMed 39655211
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt
- ClinicalTrials.gov ID
- NCT05000749
- Acronym / sponsor ID
- SDR 20-136
- Conditions
- Suicide, Attempted
- Keywords
- suicide, attempted, dialectical behavior therapy, suicide attempt, emotion regulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 11 Aug 2021 (actual)
- 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.
Veteran suicide death is a national crisis. Risk factors include emotion dysregulation, which occurs across mental health disorders. Dialectical behavior therapy (DBT) is an evidence-based suicide intervention that targets emotion dysregulation but is resource-intensive and not widely available at VHA. A more efficient evidence-based DBT Skills Group (DBT-SG) is associated with reduced suicidal ideation and emotion dysregulation and likely more feasible to implement at VHA. This is a randomized controlled trial to test whether DBT-SG in addition to VHA treatment-as-usual, compared to only VHA treatment-as-usual, reduces Veteran emotion dysregulation.
Detailed description
This is a randomized controlled trial at four VHA medical centers. Veterans will be randomized to VHA treatment-as-usual or VHA treatment-as-usual plus DBT-SG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two study conditions for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| DBT-SG plus VHA treatment as usual | Experimental | Behavioral: DBT-SG, Behavioral: VHA treatment as usualDialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness. |
| VHA treatment as usual | Active comparator | Behavioral: VHA treatment as usualVHA treatment as usual for Veterans at risk for suicide attempt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran eligible for VHA care at participating site
- two or more suicide attempts in lifetime, with one in past 12 months, on Columbia-Suicide Severity Rating Scale (C-SSRS)
- current suicidal ideation (endorsing a suicidal ideation scale of at least 1 [passive ideation] on C-SSRS
- emotion dysregulation (score 95 or greater on DERS)
- can attend group sessions
Key exclusion criteria (3 listed)
- significant cognitive impairment (score < 28 on modified Telephone Interview for Cognitive Status (mTICS)
- inability to read English or communicate in spoken and written English
- plan to move away or be unavailable in the next 18 months
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 |
|---|---|---|
| DBT-SGDialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness. | Behavioural | DBT-SG plus VHA treatment as usual |
| VHA treatment as usualVHA treatment as usual for Veterans at risk for suicide attempt | Behavioural | DBT-SG plus VHA treatment as usual, VHA treatment as usual |
Primary outcome
Change in Emotion dysregulation
Time frame: Up to18 month follow-up
Emotion dysregulation will be assessed with the Difficulties in Emotion Regulation Scale, a self-report measure. The scale ranges 36-180 with a higher score indicating greater difficulties in emotion regulation.
2 secondary outcomes
Coping
Time frame: Up to 18 month follow-up
Columbia-Suicide Severity Rating Scale
Time frame: Up to 18 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 39923893Decker SE, Kroll-Desrosiers A, Mattocks KM, Aunon FM, Galliford E, DeRycke EC, Doran N, Baird S, Rielage JK, Ridley J, Bannister J, Giovannelli TS, Fuehrlein BS, Shriver C, Spana E, Honsberger M, Demirelli SA, Shest E, Landes SJ, Goodman M, Martino S. Study protocol of a hybrid type 1 effectiveness-implementation multisite trial: Dialectical behavior therapy skills group for Veterans at high-risk for suicide attempt. Contemp Clin Trials. 2025 Apr;151:107828. doi: 10.1016/j.cct.2025.107828. Epub 2025 Feb 7.
- Derived from this study: PubMed 39655211Decker SE, Kroll-Desrosiers A, Mattocks K, Aunon FM, Galliford E, Doran N, Baird S, Rielage JK, Ridley J, Bannister J, Giovannelli TS, Landes SJ, Goodman M, Walker L, DeRycke E, Shriver C, Spana E, Honsberger M, Brown H, Demirelli S, Shest E, Martino S. Mixed-methods formative evaluation of implementing an adapted suicide prevention treatment: Dialectical Behavior Therapy Skills Groups in the Veterans Health Administration. Front Psychiatry. 2024 Nov 25;15:1495102. doi: 10.3389/fpsyt.2024.1495102. eCollection 2024.
- Individual participant dataSharing planned: No. Study data will include sensitive information about Veteran suicide risk. In consultation with the VACHS Research Office, the investigators elect not to share final data sets for this reason except as required under FOIA. Data will be preserved at VACHS on secure electronic servers behind the VA firewall, and made available for further study or validation by qualified individuals with VA IRB approval. Contact information for the corresponding mPI will be included in publications to facilitate such requests.
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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.
Suzanne Decker, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Steve Martino, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT-SG and VHA treatment as usual in people with Suicide, Attempted, run by VA Office of Research and Development at 5 sites in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Emotion dysregulation (time frame: Up to18 month follow-up). 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 NCT05000749, which also lists 2 linked publications.
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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.