Development of a Treatment Prognosis Calculator for the Prevention of Suicide

NCT06094218 | Recruiting

• 1 other identifier: 2022H0245
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Suicidal Ideation

  Assess severity of suicidal ideation at 6 months with the Scale for Suicide Ideation (SSI)

  6 Months

Secondary Outcomes (3)

• Suicide Attempts

  12 Months

• Depression

  12 Months

• Hopelessness

  12 Months

Study Arms (2)

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.

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.

Behavioral: Brief Cognitive Behavioral Therapy (BCBT)

Interventions

Brief Cognitive Behavioral Therapy (BCBT) 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.

Brief Cognitive Behavioral Therapy (BCBT)

Treatment as usual (TAU) BEHAVIORAL

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

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• Ohio State University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Harding Hospital

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Jay Fournier, PhD

CONTACT

614-293-9889; jay.fournier@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry & Behavioral Health

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 23, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)