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NCT Number: NCT07818889

Study to Refine the Effectiveness of New Generation Therapies for Suicide

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.

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Key information

Conditions

Suicide Risk Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Suicide Attempt Suicide, Attempted Treatment Response

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Behavioral Health

Columbus, Ohio, 43210, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent process

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Suicide attempts during follow-up

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

    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.

Secondary outcomes

  1. Suicidal Cognitions and Suicidal Ideation

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Crouser, MSW, LSW

CONTACT

[email protected]

614-293-2554

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • The Jordan Elizabeth Harris Foundation

Registry information

Official study title

STRENGTHENS: Study To Refine the Effectiveness of New Generation Therapies for Suicide

Acronym: STRENGTHENS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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