Suicide RiskSTRENGTHENSNCT07818889
Study to Refine the Effectiveness of New Generation Therapies for Suicide
A study testing Brief Cognitive Behavioral Therapy in people with Suicide Risk and Suicide Attempt, run by Ohio State University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Risk, Suicide Attempt, Treatment Response
- What is being tested?
- Brief Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Behavioral Health
Columbus, Ohio, 43210
About this study
Official title: STRENGTHENS: 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.
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.
- Conditions
- Suicide Risk, Suicide Attempt, Treatment Response
- Being tested
- Brief Cognitive Behavioral Therapy
- Keywords
- suicide risk, suicide attempt, suicidality
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reasons for Living | Other | Participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4. Receives: Behavioral: Brief Cognitive Behavioral Therapy |
| Sleep | Other | Sleep in session 2, physiological regulation in session 3, and reasons for living in session 4. Receives: 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). Receives: 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). Receives: Behavioral: Brief Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of study completion at one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start29 Apr 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Jordan Elizabeth Harris Foundation
- Responsible party
- Principal investigator, Melanie Bozzay, Ohio State University
- Investigators
- Melanie Bozzay, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818889
- Sponsor's protocol ID
- 20250213
- Acronym
- STRENGTHENS
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRENGTHENS: Study To Refine the Effectiveness of New Generation Therapies for Suicide
- ClinicalTrials.gov ID
- NCT07818889
- Acronym / sponsor ID
- STRENGTHENS / 20250213
- Conditions
- Suicide Risk, Suicide Attempt, Treatment Response
- Keywords
- suicide risk, suicide attempt, suicidality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- The Jordan Elizabeth Harris Foundation
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reasons for Living | Other | Behavioral: Brief Cognitive Behavioral TherapyParticipants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4. |
| Sleep | Other | Behavioral: Brief Cognitive Behavioral TherapySleep in session 2, physiological regulation in session 3, and reasons for living in session 4. |
| Cognitive Reappraisal | Other | Behavioral: Brief Cognitive Behavioral TherapyBeginning 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 Activation | Other | Behavioral: Brief Cognitive Behavioral TherapyBeginning 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Cognitive Behavioral TherapyIn 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. | Behavioural | Behavioral Activation, Cognitive Reappraisal, Reasons for Living, Sleep |
Primary outcome
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.
1 secondary outcome
Suicidal Cognitions and Suicidal Ideation
Time frame: From enrollment to the end of study completion at one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared.
Related trials for Suicide Risk
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Active, not recruiting
Clinical Trial for Integrated Care to Help At Risk Teens (iCHART) Intervention
Suicide and Depression, Adolescent Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Bozzay, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Behavioral Therapy in people with Suicide Risk and Suicide Attempt, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Crouser, MSW, LSW (614-293-2554, anna.crouser@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide attempts during follow-up (time frame: From enrollment to the end of study completion at one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.