Development of a Treatment Prognosis Calculator for the Prevention of Suicide

Not Applicable

Recruiting

• Conditions: Suicidal Ideation
• Interventions: Behavioral: Brief Cognitive Behavioral Therapy (BCBT); Behavioral: Treatment as usual (TAU)

• Registration Number: NCT06094218
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Study Start: 2023-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Cognitive Behavioral Therapy (BCBT)	Brief Cognitive Behavioral Therapy (BCBT)	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.
Treatment as Usual (TAU)	Treatment as usual (TAU)	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.

Primary Outcome Measures

Name	Time	Method
Suicidal Ideation	6 Months	Assess severity of suicidal ideation at 6 months with the Scale for Suicide Ideation (SSI)

Secondary Outcome Measures

Name	Time	Method
Suicide Attempts	12 Months	Suicide attempts will be assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
Depression	12 Months	Depression will be assessed with the PROMIS-Depression Computer Adaptive Test (CAT)
Hopelessness	12 Months	Hopelessness will be assessed with the abbreviated Beck Hopelessness Scale (BHS)

Trial Locations

Locations (1)

Harding Hospital; 🇺🇸 Columbus, Ohio, United States