Suicidal IdeationNCT06094218
Development of a Treatment Prognosis Calculator for the Prevention of Suicide
A study testing Brief Cognitive Behavioral Therapy (BCBT) and Treatment as usual (TAU) in people with Suicidal Ideation, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this interventional study is to develop and test a treatment prognosis calculator to identify which service members with suicidal ideation or behavior are likely to respond well to the current standard of care treatment and which should instead receive Brief Cognitive Behavioral Therapy (BCBT) as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Brief Cognitive Behavioral Therapy (BCBT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 Aug 2029
- Phase
- Interventional
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
- female and male active duty service members;
- => 18 years old;
- engaged in mental health treatment at one of the sites at study enrollment;
- score >0 on the Columbia Suicide Severity Rating Scale (CSSRS) Screener-Recent, or indicated suicidal ideation on questions 4 or 5 of the Scale for Suicidal Ideation, indicating suicidal ideation within the last month;
- able to understand and speak English;
- able to provide consent.
Who cannot join
- participants with a psychiatric or medical condition that prevents them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Harding Hospital
Columbus, Ohio, 43210
Jay C. J. Fournier, PhD, 6142939889, jay.fournier@osumc.edu
About this study
The goal of this interventional study is to develop and test a treatment prognosis calculator to identify which service members with suicidal ideation or behavior are likely to respond well to the current standard of care treatment and which should instead receive Brief Cognitive Behavioral Therapy (BCBT) as a first-line treatment.
The main aims of the study are:
Read more
- Aim 1: To develop a novel treatment prognostic calculator to predict response to treatment as usual (TAU) and identify treatment-seeking military personnel who are unlikely to respond adequately to TAU for the reduction of suicidal ideation.
- Aim 2: To evaluate the performance of the treatment prognosis calculator in a new sample of treatment-seeking military personnel and determine whether BCBT is more effective than TAU for those patients who are predicted not to respond adequately to TAU.
Participants will receive mental health treatment as it is typically administered by their mental healthcare treatment team. Members of their mental healthcare treatment team may receive intensive training in BCBT. After their provider has received this training, they may use this treatment as part of standard of care treatment. The timing of this training will be determined randomly. Participants will complete self-report assessments at the beginning of the study (baseline) as well as 3, 6, 9 and 12 months after their participant begins. These assessments will include questions about feelings, thoughts, moods, impulses, substance use, and behavior.
- Conditions
- Suicidal Ideation
- Being tested
- Brief Cognitive Behavioral Therapy (BCBT), Treatment as usual (TAU)
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive Behavioral Therapy (BCBT)Behavioural
BCBT was developed to provide patients with the skills they need to better manage the cognitive, emotional, physiological, and behavioral components of acute suicidal crises.
Treatment as usual (TAU)Behavioural
Behavioral health treatment as it is typically provided at the treatment site.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | TAU may include (1) routine suicide risk screening and assessment; (2) safety planning with means restriction; and (3) the Collaborative Assessment and Management of Suicidality (CAMS), an evidence-based approach to managing and treating suicidal patients. Receives: Behavioral: Treatment as usual (TAU) |
| Brief Cognitive Behavioral Therapy (BCBT) | Experimental | BCBT consists of 12 outpatient individual psychotherapy sessions scheduled weekly or biweekly. The first session is 90 minutes and subsequent sessions are 60 minutes. BCBT is divided into three phases. In phase 1 (5 sessions), the therapist conducts a detailed assessment of the patient's most recent suicidal episode or suicide attempt, identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase 2 (5 sessions), the therapist teaches cognitive restructuring skills to build cognitive flexibility. In phase 3 (2 sessions), a relapse prevention task is conducted, and participants must demonstrate the ability to successfully complete this task in order to terminate the treatment. Additional sessions are conducted until participants demonstrate the ability to successfully complete this task. Receives: Behavioral: Brief Cognitive Behavioral Therapy (BCBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation
Assess severity of suicidal ideation at 6 months with the Scale for Suicide Ideation (SSI)
Measured: 6 Months
Secondary outcomes (3)
Suicide Attempts
Suicide attempts will be assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
Measured: 12 Months
Depression
Depression will be assessed with the PROMIS-Depression Computer Adaptive Test (CAT)
Measured: 12 Months
Hopelessness
Hopelessness will be assessed with the abbreviated Beck Hopelessness Scale (BHS)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two phase, stepped-wedge design. In Phase I, all participants receive TAU. In Phase II, sites are randomized to receive training in BCBT. Prior to the training, participants receive TAU. Following the training, participants may receive BCBT.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Jay Fournier, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094218
- Sponsor's protocol ID
- 2022H0245
- Status last verified
- Feb 2026
- First submitted
- 3 Oct 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No