Development of a Treatment Prognosis Calculator for the Prevention of Suicide

Suicidal Ideation Clinical Trial

Official title:

Development of a Treatment Prognosis Calculator for the Prevention of Suicide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094218
• Other study ID #: 2022H0245
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: November 2023
• Source: Ohio State University
• Contact: Jay Fournier, PhD
• Phone: 614-293-9889
• Email: jay.fournier[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, 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).

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• 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.
• Treatment as usual (TAU)
Behavioral health treatment as it is typically provided at the treatment site.

Locations

Country	Name	City	State
United States	Harding Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Ideation	Assess severity of suicidal ideation at 6 months with the Scale for Suicide Ideation (SSI)	6 Months
Secondary	Suicide Attempts	Suicide attempts will be assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)	12 Months
Secondary	Depression	Depression will be assessed with the PROMIS-Depression Computer Adaptive Test (CAT)	12 Months
Secondary	Hopelessness	Hopelessness will be assessed with the abbreviated Beck Hopelessness Scale (BHS)	12 Months