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Development of a Treatment Prognosis Calculator for the Prevention of Suicide

Development of a Treatment Prognosis Calculator for the Prevention of Suicide

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06094218
Enrollment
1200
Registered
2023-10-23
Start date
2023-10-31
Completion date
2027-08-31
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation

Brief 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 first-line treatment. The main aims of the study are: * 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.

Interventions

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.

BEHAVIORALTreatment as usual (TAU)

Behavioral health treatment as it is typically provided at the treatment site.

Sponsors

Ohio State University
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. female and male active duty service members; 2. =\> 18 years old; 3. engaged in mental health treatment at one of the sites at study enrollment; 4. 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; 5. able to understand and speak English; 6. able to provide consent.

Exclusion criteria

(1) 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).

Design outcomes

Primary

MeasureTime frameDescription
Suicidal Ideation6 MonthsAssess severity of suicidal ideation at 6 months with the Scale for Suicide Ideation (SSI)

Secondary

MeasureTime frameDescription
Suicide Attempts12 MonthsSuicide attempts will be assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
Depression12 MonthsDepression will be assessed with the PROMIS-Depression Computer Adaptive Test (CAT)
Hopelessness12 MonthsHopelessness will be assessed with the abbreviated Beck Hopelessness Scale (BHS)

Countries

United States

Contacts

CONTACTJay Fournier, PhD
jay.fournier@osumc.edu614-293-9889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026