What side effects are associated with this type of intervention?

Common treatments for psychosis include antipsychotic medications and cognitive-behavioral therapies (CBT). Antipsychotic medications, such as clozapine, risperidone, and olanzapine, can cause side effects like weight gain, metabolic syndrome, sedation, and extrapyramidal symptoms (e.g., tremors, rigidity). Cognitive-behavioral therapies, including those aimed at reducing suicidal thoughts and behaviors, generally have fewer physical side effects but may cause emotional discomfort as patients confront distressing thoughts and behaviors. Overall, while CBT is considered safe, the side effects of antipsychotic medications necessitate careful monitoring.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of psychosis, including drugs like olanzapine, risperidone, and aripiprazole. These medications primarily target symptoms such as hallucinations, delusions, and disorganized thinking. While cognitive-behavioral therapy (CBT) techniques, such as those used in the CBSPp trial, are not FDA-approved as standalone treatments, they are often used adjunctively with pharmacotherapy to address specific issues like suicidal thoughts and behaviors in individuals with psychosis. The combination of medication and CBT has shown promise in improving overall outcomes for patients with psychosis.

What other types of research exist?

Promising novel alternatives to CBSPp for psychosis patients include: 1) Psilocybin-assisted psychotherapy, which has shown potential in reducing psychiatric and existential distress; 2) MDMA-assisted psychotherapy, currently under expanded access programs for PTSD, which may offer benefits for psychosis-related suicidal ideation; 3) Integrated treatment models combining pharmacotherapy with assertive community treatment (ACT) to address both mental health and substance use disorders; 4) Lifestyle interventions focusing on weight management and cardiovascular health, which can improve overall well-being and potentially reduce suicidal behaviors.

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Cognitive Behavioral Therapy for Suicide Prevention in Psychosis

N/A

Recruiting

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 18 to 65 years

Suicide ideation and/or attempt within 3 months of screening

Must not have

Presence of impaired cognitive capacity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-months after baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special therapy called CBSPp to help adults with schizophrenia who have had recent suicidal thoughts. The therapy aims to change harmful thoughts and behaviors to reduce the risk of suicide.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves psychological therapy rather than medication, typical side effects associated with drugs are not expected. However, discussing sensitive topics like suicide may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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

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I have been diagnosed with a schizophrenia spectrum disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty with thinking or memory.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-months after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Calgary Depression Rating Scale (CDRS) change from baseline

Columbia Suicide Severity Rating Scale (C-SSRS) change from baseline

Positive and Negative Syndrome Scale (PANSS) change from baseline

Secondary study objectives

Beck Hopelessness Scale change from baseline

Defeat Scale (D Scale) change from baseline

Resilience Appraisals Scale (RAS) change from baseline

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioral Suicide Prevention for psychosis (treatment group)Experimental Treatment1 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 Control1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for psychosis include antipsychotic medications and cognitive-behavioral therapy (CBT). Antipsychotic medications work by altering the effects of neurotransmitters in the brain, particularly dopamine, to reduce symptoms like hallucinations and delusions. Cognitive-behavioral therapy, including specialized forms like Cognitive Behavioral Suicide Prevention for psychosis (CBSPp), focuses on changing negative thought patterns and behaviors. This is crucial for psychosis patients as it helps them manage symptoms, reduce suicidal thoughts, and improve overall functioning. By addressing both the biological and psychological aspects of the disorder, these treatments provide a comprehensive approach to managing psychosis.