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SuicidePhase 2NCT05931289

Suicide Risk Interventions

A Phase 2 study testing Enhanced Crisis Response Planning (ECRP) and Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) in people with Suicide, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The suicide rate among active duty service members and Veterans increased substantially following the onset of post-9/11 conflicts in Iraq and Afghanistan. Accordingly, Veteran suicide prevention has been identified as a national healthcare and research priority. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide
What is being tested?
Enhanced Crisis Response Planning (ECRP) and Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteUnited States
Study dates
3 Mar 2025to 31 Dec 2027
Phase
Phase 2
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

  • hospitalization for a recent suicidal crisis consisting of SI with intent to die within the past week and/or a suicide attempt within the past month
  • Veteran status
  • ability to speak English
  • ability to complete the informed consent process
  • willingness/ability to attend 12 outpatient treatment sessions and 3 fMRI sessions following hospital discharge

Who cannot join

  • significant cognitive impairment
  • current psychotic or manic features

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael S Esterman, PhD contact

(857) 364-4362

Michael.Esterman@va.gov

United States1 site, 1 recruiting
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817

    Michael S Esterman, PhD, 857-364-4362, Michael.Esterman@va.gov

    Michael S Esterman, PhD

    Recruiting

Other trials in United States

About this study

Official title: Suicide Risk Interventions: A Comparison of Treatment Dose and Neural Markers of Treatment Outcome

The suicide rate among active duty service members and Veterans increased substantially following the onset of post-9/11 conflicts in Iraq and Afghanistan. Accordingly, Veteran suicide prevention has been identified as a national healthcare and research priority. The investigators will recruit 136 female and male Veterans who have been hospitalized for suicide risk and randomly assign them to receive one of two psychotherapy treatments for suicide risk after they leave the hospital. The goals of this study are to examine if a) a longer psychotherapy causes greater improvements in coping skills and reductions in negative suicidal thinking, b) a longer psychotherapy is more effective in reducing suicide risk, and c) if Veterans with a history of multiple suicide attempts are more likely to benefit from the longer psychotherapy. Additionally, this study will use magnetic resonance imaging (MRI) neuroimaging scans of Veterans shortly after they leave the hospital and again 4- and 12-months later. This study will explore a) if brain markers can predict suicide attempts, b) if brain markers change over time as suicide risk changes, and c) if brain markers change differently for the two types of psychotherapy.

Read the detailed description

The suicide rate among active duty service members and Veterans increased substantially following the onset of post-9/11 conflicts in Iraq and Afghanistan. Accordingly, Veteran suicide prevention has been identified as a national healthcare and research priority. Psychosocial interventions for suicide risk vary substantially in dose and resource allocation. Single-session interventions (e.g., Enhanced Crisis Response Plans [ECRP]) has been shown to reduce risk for future suicide attempts. Other interventions consisting of 10-12 outpatient sessions following inpatient discharge (e.g., Brief Cognitive Behavioral Therapy for suicide prevention [BCBT]) have been shown to reduce suicide attempts by 50-60% relative to treatment as usual. Although both forms of intervention have been shown to reduce risk, interventions that vary in dose and resource allocation have yet to be directly compared, leaving two critical gaps in the ability to intervene most effectively. First, the assumption that more time- and resource-intensive 10-12 session interventions translate to greater suicide risk reduction has yet to be demonstrated. Second, it may be that less resource intensive interventions are adequate for some individuals whereas others require more intensive care.

Pharmacological and brain stimulation interventions for suicide risk are extremely limited. This is due, in part, to an incomplete understanding of the neurobiological mechanisms of suicide risk. Although numerous studies have examined cross-sectional neuroimaging correlates of current suicide ideation or compared individuals with and without history of a suicide attempt, to date no studies have examined a) neurobiological predictors of future suicide attempts in high-risk samples, b) how changes in neurobiological markers over time relate to changes in suicide risk, or c) theoretically and mechanistically relevant neuroimaging procedures in a prospective design. Cross-sectional research examining neuroimaging markers of past or current self-injurious thoughts and behaviors (SITBs) has identified dysfunction in cognitive control networks (CCN) regions associated with emotion regulation, inhibitory control, and decision-making. On the other hand, dysfunction has also been observed in regions associated with negative affect and rumination such as limbic (LN) and default mode (DMN) networks. Despite these findings, identification of neuroimaging predictors of future suicide attempts, and neural markers of successful suicide risk intervention outcomes represents a completely novel, critical step to guiding optimal targeting of neurobiological interventions and translating these findings into practice. Whether these potential neuroimaging predictors are identifiable during resting state, or whether more suicide-relevant cognitive tasks are required, remains an open yet critical question.

The purpose of the investigators' proposed study is to compare two evidence-based suicide risk interventions that vary in dose in order to a) directly test if a more intensive intervention produces greater risk reduction, b) identify Veterans for whom a more intensive intervention is indicated, and c) identify resting-state and task-based neurobiological markers of future suicide attempts and examine how changes in these markers relate to changes in suicide risk over time. The investigators will recruit and evenly randomize 136 male and female Veterans hospitalized for suicide risk to ECRP or BCBT. The investigators will collect neuroimaging data immediately upon discharge, post-treatment, and 12-months post-discharge and assess SITBs out to 12-months post-discharge.

Conditions
Suicide
Being tested
Enhanced Crisis Response Planning (ECRP), Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)
Keywords
Suicide
Medical subject headings
Suicide

What participants receive

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

  • Enhanced Crisis Response Planning (ECRP)Behavioural

    Using supportive listening, a therapist conducts a brief interview to gather information about lifetime suicide attempt history and recent SI. The therapist then works with the client to identify a) warning signs for being in crisis, b) self-management/distraction strategies, c) reasons for living, d) sources of social support the client could contact in the event of a crisis, and e) crisis resources (e.g., veterans crisis line, contact information for current providers and local emergency resources). Steps for each of these, as well as specific contacts for social support and professional services are written on an index card provided to the patient and the patient is encouraged to keep the card in an accessible place (e.g., wallet) so it can be utilized in the event of a crisis.

  • Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)Behavioural

    This weekly, 12-session intervention involves completion of an enhanced crisis response plan, as well as emotion regulation skills training, learning strategies to identify and challenge thinking patterns that contribute to suicide risk, and increased engagement in personally meaningful activities.

Study groups in NCT05931289
Study groupRoleWhat they receive
Enhanced Crisis Response PlanningActive comparatorUsing supportive listening, a therapist conducts a brief interview to gather information about lifetime suicide attempt history and recent SI. The therapist then works with the client to identify a) warning signs for being in crisis, b) self-management/distraction strategies, c) reasons for living, d) sources of social support the client could contact in the event of a crisis, and e) crisis resources (e.g., veterans crisis line, contact information for current providers and local emergency resources). Steps for each of these, as well as specific contacts for social support and professional services are written on an index card provided to the patient and the patient is encouraged to keep the card in an accessible place (e.g., wallet) so it can be utilized in the event of a crisis.
Receives: Behavioral: Enhanced Crisis Response Planning (ECRP)
Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)Active comparatorThis weekly, 12-session intervention involves completion of an enhanced crisis response plan, as well as emotion regulation skills training, learning strategies to identify and challenge thinking patterns that contribute to suicide risk, and increased engagement in personally meaningful activities.
Receives: Behavioral: Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)

What is being measured

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

  1. Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)

    The SITBI-R is a structured interview assessment of the frequency, intensity, and characteristics of self-injurious thoughts and behaviors. The SITBI-R will be used to assess lifetime history of suicide attempts at baseline and the number, approximate date, method, and injuries resulting from any suicide attempts occurring during the 12-month period following discharge via administrations at the 2, 4, 8, and 12-month post-discharge assessments.

    Measured: Change since hospital discharge (via administrations at the 2, 4, 8, and 12-month post-discharge assessments)

Secondary outcomes (1)
  1. Scale for Suicide Ideation (SSI)

    The SSI is a 19-item interview measure of suicidal thoughts, administered at baseline and the 2, 4, 8, and 12-month post-discharge assessments.

    Measured: Worst point (administered at baseline and the 2, 4, 8, and 12-month post-discharge assessments)

Timeline

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

  1. First posted5 Jul 2023
  2. Study start3 Mar 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05931289
Sponsor's protocol ID
MHBC-004-22F
Other IDs
I01CX002583
Status last verified
Feb 2026
First submitted
26 Jun 2023
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified datasets will include all data underlying any publications generated by this study and are therefore sufficient to reproduce or verify any published findings. Data will be securely stored on a local network behind the VA firewall, in the PI's folder on an encrypted computer. Records kept in this location will also contain reference to the corresponding publication(s), completing the association between publications and corresponding datasets. De-identified data-sets corresponding to published papers will only be available through filing Freedom of Information Act requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enhanced Crisis Response Planning (ECRP) and Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) in people with Suicide, run by VA Office of Research and Development at 1 site 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Michael S Esterman, PhD ((857) 364-4362, Michael.Esterman@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) (time frame: Change since hospital discharge (via administrations at the 2, 4, 8, and 12-month post-discharge assessments)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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