Study to Refine the Effectiveness of New Generation Therapies for Suicide

NCT07818889 | Recruiting

• 1 other identifier: 20250213
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to improve the effectiveness of a well-established therapy for suicidal thoughts and behaviors called Brief Cognitive Behavioral Therapy (BCBT) for Suicide Prevention.

Conditions

Suicide Risk; Suicide Attempt; Treatment Response

Keywords

suicide risk; suicide attempt; suicidality

Outcome Measures

Primary Outcomes (1)

• Suicide attempts during follow-up

  The primary outcome is suicide attempts during follow-up, assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R). SITBI-R responses will be used to determine the rate of participants making a follow-up suicide attempt (binary) and the rate of follow-up suicide attempts per participant-year across treatment arms.

  From enrollment to the end of study completion at one year.

Secondary Outcomes (1)

• Suicidal Cognitions and Suicidal Ideation

  From enrollment to the end of study completion at one year.

Study Arms (4)

Reasons for Living

OTHER

Participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4.

Behavioral: Brief Cognitive Behavioral Therapy

Sleep

OTHER

Sleep in session 2, physiological regulation in session 3, and reasons for living in session 4.

Behavioral: Brief Cognitive Behavioral Therapy

Cognitive Reappraisal

OTHER

Beginning at week 4, participants will be classified as treatment responders if they (1) have not engaged in any preparatory behavior or made any suicide attempts (aborted, interrupted, or actual) and (2) have an SCS-R total score ≤21. Participants who do not meet these criteria will continue BCBT and be randomized a second time to determine if cognitive reappraisal or behavioral activation components are delivered next (sessions 5-9).

Behavioral: Brief Cognitive Behavioral Therapy

Behavioral Activation

OTHER

Beginning at week 4, participants will be classified as treatment responders if they (1) have not engaged in any preparatory behavior or made any suicide attempts (aborted, interrupted, or actual) and (2) have an SCS-R total score ≤21. Participants who do not meet these criteria will continue BCBT and be randomized a second time to determine if cognitive reappraisal or behavioral activation components are delivered next (sessions 5-9).

Behavioral: Brief Cognitive Behavioral Therapy

Interventions

Brief Cognitive Behavioral Therapy BEHAVIORAL

In this study, BCBT skills will be introduced in various randomly determined sequence. During the first stage, around half of participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4. The other half of participants will complete these components in the reverse order: sleep in session 2, physiological regulation in session 3, and reasons for living in session 4. Treatment non-responders will continue attending BCBT sessions during Stage 2 following their 4 completed sessions in Stage 1, up to a maximum of 6 additional sessions (i.e., 10 therapy sessions total across both stages). The specific sequence of the BCBT skills used in Stage 2 will be randomly assigned.

Behavioral Activation; Cognitive Reappraisal; Reasons for Living; Sleep

Eligibility Criteria

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

You may qualify if:

• years of age or older; suicidal ideation (assessed with the SSI) and/or suicidal behavior within the past month (assessed with the SITBI-R), psychiatric hospitalization for elevated suicide risk within the past month, and/or SCS-R total score \>21; eligibility to understand and speak the English language; ability to complete the informed consent process

You may not qualify if:

• impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania) and/or a medical or psychiatric condition that precludes the ability to engage in outpatient therapy

Sponsors & Collaborators

• Ohio State University: lead
• The Jordan Elizabeth Harris Foundation: collaborator

Study Sites (1)

Department of Psychiatry and Behavioral Health

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Melanie Bozzay, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Crouser, MSW, LSW

CONTACT

614-293-2554; anna.crouser@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Suicide Prevention, Associate Professor

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)