Cognitive Behavioral Therapy for Suicide Prevention in Psychosis

Overseen By Lindsay A Bornheimer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Emergency care, Impaired capacity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) might assist individuals with schizophrenia who have recently experienced suicidal thoughts or actions. The goal is to determine if this therapy is more effective than the usual care. Participants will be divided into two groups: one will receive the new therapy alongside their usual care, while the other will continue with their standard services. The study seeks individuals with schizophrenia who have considered or attempted suicide in the past three months and are already receiving community mental health services. As an unphased trial, it offers a unique opportunity to enhance understanding and improve mental health care for those with schizophrenia.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is generally safe. Studies have found that most participants handle this treatment well. Past trials reported no serious negative effects. The treatment involves discussing issues in a structured way, which typically carries fewer risks than medication-based treatments. Participants have not reported major side effects, making CBSPp a promising option for those experiencing suicidal thoughts and psychosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) because it offers a tailored approach to tackling suicide risk in individuals with psychosis. Unlike standard treatments, which generally involve medication and broad-based therapy, CBSPp focuses specifically on suicide prevention through targeted cognitive-behavioral techniques. Delivered through 10 weekly individual therapy sessions, it emphasizes personalized strategies that address the unique thought patterns and challenges faced by this group. This specialized focus has the potential to enhance the effectiveness of current care models, offering new hope for better outcomes.

What evidence suggests that Cognitive Behavioral Suicide Prevention for psychosis could be effective for preventing suicide in individuals with psychosis?

Research has shown that Cognitive Behavioral Suicide Prevention for psychosis (CBSPp), which participants in this trial may receive, can help reduce suicidal thoughts and feelings of hopelessness. Early results suggest that individuals who received CBSPp felt less depressed and experienced fewer symptoms related to psychosis. Studies also indicate that this method can lessen feelings of being trapped and defeated, often linked to suicidal behavior. While more research is needed to confirm these benefits, early evidence is promising for those dealing with schizophrenia-related disorders and suicidal thoughts. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-65 with a schizophrenia spectrum disorder who have had suicidal thoughts or behaviors in the last 3 months. It's not suitable for those needing emergency care, with impaired cognitive capacity, or deemed inappropriate for behavioral treatment.

Inclusion Criteria

I have not had thoughts or attempts of suicide in the last 3 months.

Ability to speak and read in English

I have been diagnosed with a schizophrenia spectrum disorder.

Exclusion Criteria

I have difficulty with thinking or memory.

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)

Deemed inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

Treatment

Participants receive Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in 10 weekly individual therapy sessions

10 weeks

10 visits (in-person)

Assessment

Quantitative assessments at baseline, 1-month, 3-months, and 5-months after baseline with in-depth qualitative interviews at 3-months

5 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)
• Services as Usual (SAU)

Trial Overview The study tests Cognitive Behavioral Suicide Prevention tailored for psychosis (CBSPp) against standard services (SAU). Participants will be randomly assigned to one of these two groups and evaluated over five months through interviews and assessments.

How Is the Trial Designed?

Group I: Cognitive Behavioral Suicide Prevention for psychosis (treatment group) Experimental Treatment 1 Intervention

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.

Group II: Services as Usual (SAU; comparison group) Active Control 1 Intervention

Services as usual involve standard and current services that clients are eligible for receiving.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11241875/

A cognitive-behavioral treatment for suicide prevention ... However, cognitive-behavioral therapy for psychosis (CBTp) lacks an evidence base that demonstrates efficacy in reducing suicide thoughts and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05345184

Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2 Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38997747/

A cognitive-behavioral treatment for suicide prevention among ... This randomized pilot trial will provide clinically relevant information about whether CBSPp can improve SI/A, depression, and psychosis among adults with SSDs.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996414002011

The cognitive behavioural prevention of suicide in psychosis Measures of suicide probability, and suicidal ideation were the primary outcomes and measures of hopelessness, depression, psychotic symptoms, functioning, and ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/15332985.2023.2186736

A cognitive-behavioral suicide prevention treatment for ... Clients experienced improvements in suicide ideation, depression, hopelessness, general symptoms of psychosis, entrapment, defeat, approaches to ...

6. firearminjury.umich.edu firearminjury.umich.edu/publication/a-cognitive-behavioral-treatment-for-suicide-prevention-among-adults-with-schizophrenia-spectrum-disorders-in-community-mental-health-study-protocol-for-a-pilot-feasibility-and-acceptability-randomiz/

A cognitive-behavioral treatment for suicide prevention among ... This randomized pilot trial will provide clinically relevant information about whether CBSPp can improve SI/A, depression, and psychosis among adults with SSDs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10506844/

A cognitive-behavioral suicide prevention treatment for adults ... This paper presents on open pilot study findings of the modified CBSPp treatment among CMH clients and social work providers to inform final modifications prior ...

8. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(24)00399-7/fulltext

Underlying mechanisms and efficacy of a suicide-focused ... Procedures. CBSPp is a collaborative, formulation-based, cognitive behavioural intervention for people with suicidal experiences and psychosis.