What side effects are associated with this type of intervention?

Common treatments for schizophrenia include second-generation antipsychotics and behavioral therapies like cognitive-behavioral therapy (CBT). Second-generation antipsychotics can cause side effects such as extrapyramidal symptoms, weight gain, and metabolic syndrome. Behavioral therapies, which aim to modify thought patterns and improve coping strategies, generally have fewer physical side effects but require significant patient engagement and time.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (typical) antipsychotics like haloperidol and second-generation (atypical) antipsychotics such as clozapine, olanzapine, risperidone, and quetiapine. These medications primarily target dopamine receptors to alleviate symptoms. Behavioral therapy, which modifies thought patterns and improves coping strategies, is often used alongside pharmacotherapy to reduce violent behavior and improve overall functioning. While the primary focus of FDA approvals has been on pharmacological treatments, integrating behavioral therapy is a common practice to enhance treatment outcomes.

What other types of research exist?

Promising novel alternatives to Behavioral Therapy for Schizophrenia patients include: 1) Assertive Community Treatment (ACT), which integrates comprehensive community-based care; 2) Acceptance and Commitment Therapy (ACT), focusing on mindfulness and acceptance strategies; 3) Pharmacological advancements such as second-generation antipsychotics with fewer side effects; and 4) Integrated treatment models combining pharmacotherapy with psychosocial interventions tailored to individual needs.

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Behavioral Therapy for Early Psychosis

N/A

Recruiting

Led By Stephanie Rolin, MD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Summary

This trial is testing a program that helps people with early psychosis learn new ways to manage their emotions and actions to reduce violent behavior.

Who is the study for?

This trial is for young adults aged 16 to 30 who are receiving treatment for early psychosis at OnTrackNY clinics and can participate in research interviews. They must have a diagnosis within the schizophrenia spectrum, excluding affective psychoses, and be fluent in English.

What is being tested?

The study tests an adapted behavioral intervention designed to reduce violent behavior in individuals with early-stage nonaffective psychotic disorders such as schizophrenia.

What are the potential side effects?

Since this is a behavioral intervention rather than a medication, traditional side effects are not expected. However, participants may experience emotional or psychological discomfort during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean Acceptability of Intervention Measure (AIM)

Mean Feasibility of Intervention Measure (FIM)

Number of EIS Participants in Attendance

Trial Design

1Treatment groups

Experimental Treatment

Group I: behavioral interventionExperimental Treatment1 Intervention

This will involve conducting a 12-week open pilot trial (up to n=16 dyads of EIS clinicians-EIS participants) to test the feasibility and acceptability of the adapted Psychological Interventions for Coping with Anger and Schizophrenia: a study of outcomes (PICASSO) intervention in the OnTrackNY setting.

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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 schizophrenia include behavioral therapies like Cognitive Behavioral Therapy (CBT) and antipsychotic medications. CBT helps modify thought patterns and improve coping strategies, which is crucial for managing symptoms such as delusions and hallucinations, reducing violent behavior, and enhancing social functioning. Antipsychotic medications work by altering neurotransmitter activity, particularly dopamine, to reduce psychotic symptoms. Combining these treatments offers a comprehensive approach, addressing both the biological and psychological aspects of schizophrenia.

Are Group Psychotherapeutic Treatments Effective for Patients with Schizophrenia? A Systematic Review and Meta-Analysis.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,471 Previous Clinical Trials

2,536,334 Total Patients Enrolled

24 Trials studying Schizophrenia

3,310 Patients Enrolled for Schizophrenia

National Institute of Mental Health (NIMH)NIH

2,869 Previous Clinical Trials

2,777,520 Total Patients Enrolled

253 Trials studying Schizophrenia

89,908 Patients Enrolled for Schizophrenia

Stephanie Rolin, MD, MPHPrincipal InvestigatorColumbia University

Media Library

Adapted Behavioral Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05756855 — N/A

Schizophrenia Research Study Groups: behavioral intervention

Schizophrenia Clinical Trial 2023: Adapted Behavioral Intervention Highlights & Side Effects. Trial Name: NCT05756855 — N/A

Adapted Behavioral Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05756855 — N/A

~11 spots leftby Aug 2026

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