SuicideNCT05345184
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2
A study testing Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) and Services as Usual (SAU) in people with Suicide and Psychosis, run by University of Michigan at 1 site in United States.
Trial summary
Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) and Services as Usual (SAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia Spectrum Disorder
- Suicide ideation and/or attempt within 3 months of screening
- Ability to speak and read in English
- 18 to 65 years of age
Who cannot join
- Requiring emergency care (e.g. imminent plan to harm self) as determined by trained research staff administering the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH
- Impaired capacity (cognitive capacity)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive Behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 2 RCT
Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.
- Being tested
- Cognitive Behavioral Suicide Prevention for psychosis (CBSPp), Services as Usual (SAU)
- Keywords
- suicide prevention, cognitive behavioral therapy, community mental health
- Medical subject headings
- Suicide, Psychotic Disorders, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)Behavioural
Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
Services as Usual (SAU)Behavioural
Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Suicide Prevention for psychosis (treatment group) | Experimental | Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services. Receives: Behavioral: Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) |
| Services as Usual (SAU; comparison group) | Active comparator | Services as usual involve standard and current services that clients are eligible for receiving. Receives: Behavioral: Services as Usual (SAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calgary Depression Rating Scale (CDRS)
A scale to measure depression, higher scores indicate greater depression (range of 0-27)
Measured: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Positive and Negative Syndrome Scale (PANSS)
A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210)
Measured: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Columbia Suicide Severity Rating Scale (C-SSRS)
A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5)
Measured: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Secondary outcomes (3)
Beck Hopelessness Scale
A scale to measure hopelessness, higher scores indicate greater hopelessness (range of 0-20)
Measured: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Defeat Scale (D Scale)
A scale to measure defeat, higher scores indicate greater defeat (range of 0-64)
Measured: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
The Entrapment Scale
A scale to measure entrapment, higher scores indicate greater entrapment (range of 0-64)
Measured: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Sep 2022
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lindsay Bornheimer, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345184
- Sponsor's protocol ID
- HUM00211008
- Other IDs
- R34MH123609
- Status last verified
- Feb 2026
- First submitted
- 12 Apr 2022
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upload to NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive Behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 2 RCT
- ClinicalTrials.gov ID
- NCT05345184
- Acronym / sponsor ID
- HUM00211008
- Keywords
- suicide prevention, cognitive behavioral therapy, community mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 20 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Suicide Prevention for psychosis (treatment group) | Experimental | Behavioral: Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services. |
| Services as Usual (SAU; comparison group) | Active comparator | Behavioral: Services as Usual (SAU)Services as usual involve standard and current services that clients are eligible for receiving. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Schizophrenia Spectrum Disorder
- Suicide ideation and/or attempt within 3 months of screening
- Ability to speak and read in English
- 18 to 65 years of age
Key exclusion criteria (3 listed)
- Requiring emergency care (e.g. imminent plan to harm self) as determined by trained research staff administering the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH
- Impaired capacity (cognitive capacity)
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 |
|---|---|---|
| Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis | Behavioural | Cognitive Behavioral Suicide Prevention for psychosis (treatment group) |
| Services as Usual (SAU)Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management) | Behavioural | Services as Usual (SAU; comparison group) |
Primary outcome
Calgary Depression Rating Scale (CDRS)
Time frame: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
A scale to measure depression, higher scores indicate greater depression (range of 0-27)
Positive and Negative Syndrome Scale (PANSS)
Time frame: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210)
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5)
3 secondary outcomes
Beck Hopelessness Scale
Time frame: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Defeat Scale (D Scale)
Time frame: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
The Entrapment Scale
Time frame: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upload to NIMH Data Archive
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) and Services as Usual (SAU) in people with Suicide and Psychosis, run by University of Michigan 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Mar 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?
Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calgary Depression Rating Scale (CDRS) (time frame: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).). The study lists 3 primary outcomes in all. 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 20 Mar 2026.