ClinicalTrials.gg
RecruitingNCT07818889STRENGTHENSUpdated Sep 14, 2026

Study to Refine the Effectiveness of New Generation Therapies for Suicide

An interventional study of Brief Cognitive Behavioral Therapy in Suicide Risk, Suicide Attempt and Treatment Response, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Ohio State University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2026, registered Sep 2026).
  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Funded by The Jordan Elizabeth Harris Foundation, this study uses a Sequential Multiple Assignment Randomized Trial (SMART) design to evaluate how various sequences and doses of BCBT components differentially impact suicide risk. In this two-stage clinical trial, all participants will initially receive 4 sessions of BCBT and complete weekly assessments. They will also complete 4 weeks of ecological momentary assessment (EMA) and digital phenotyping procedures during the first month of treatment.

02

Conditions studied

  • Suicide Risk
  • Suicide Attempt
  • Treatment Response

Keywords

  • suicide risk
  • suicide attempt
  • suicidality
03

In context

Suicide, Attempted

281 studies on the registry are indexed under Suicide, Attempted; 91 are open to participants now.

This study's planned enrollment of 50 is below the median of 129 across 224 interventional studies indexed under Suicide, Attempted.

Browse Suicide, Attempted studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 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 process

Exclusion criteria

Exclusion Criteria:

  • impaired mental status that precludes the ability to provide (e.g., intoxication, psychosis, mania) and/or a medical or psychiatric condition that precludes the ability to engage in outpatient therapy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Reasons for Living

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

    Behavioral: Brief Cognitive Behavioral Therapy

  • Other
    Sleep

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

    Behavioral: Brief Cognitive Behavioral Therapy

  • Other
    Cognitive Reappraisal

    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

  • Other
    Behavioral Activation

    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

  • BehavioralBrief Cognitive Behavioral Therapy

    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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Suicidal Cognitions and Suicidal Ideation

    Suicidal beliefs will be assessed using the SCS-R.15 SCS-R scores assess future risk for attempting suicide. Severity of suicidal ideation will be assessed using the Scale for Suicide Ideation (SSI),16 a 19-item self-report scale that measures the intensity of suicide-related thoughts, urges, and behaviors.

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

07

Study locations

1 of 1 sites recruiting
  • Department of Psychiatry and Behavioral Health
    Columbus, Ohio 43210, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07818889
Collaborators
The Jordan Elizabeth Harris Foundation
Responsible party
Melanie Bozzay (Director of Suicide Prevention, Associate Professor, Ohio State University) — Principal investigator
First posted
Sep 14, 2026
Start date
Apr 29, 2026
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 14, 2026

Study contacts

Anna Crouser, MSW, LSW
Contact
anna.crouser@osumc.edu
614-293-2554
Melanie Bozzay, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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