Development of a Treatment Prognosis Calculator for the Prevention of Suicide

NCT ID: NCT06094218

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-08-31

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.

Conditions

Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Brief Cognitive Behavioral Therapy (BCBT)

Intervention Type: BEHAVIORAL

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.

Interventions

Brief Cognitive Behavioral Therapy (BCBT)

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.

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jay Fournier

Associate Professor, Department of Psychiatry & Behavioral Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harding Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jay Fournier, PhD

Role: CONTACT

jay.fournier@osumc.edu

614-293-9889

Facility Contacts

Jay C. J. Fournier, PhD

Role: primary

jay.fournier@osumc.edu

6142939889

Other Identifiers

2022H0245

Identifier Type: -

Identifier Source: org_study_id