Young Adults With Violent Behavior During Early Psychosis

Schizophrenia Clinical Trial

Official title:

Young Adults With Violent Behavior During Early Psychosis: An Open Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756855
• Other study ID #: NYSPI 8451
• Secondary ID: K23MH126312
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: August 2027

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Stephanie Rolin, MD, MPH
• Phone: 212-305-8075
• Email: stephanie.rolin[@]nyspi.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.

Description:

The investigators will conduct an open pilot trial of a behavioral intervention to reduce violent behavior within the OnTrackNY network. The focus of this open pilot is to explore the acceptability and feasibility of the intervention. The study will enroll early intervention service (EIS) clinician - EIS participant dyads. The planned sample size is 3-4 EIS clinicians and 10-16 EIS participants (up to n=16 dyads). This real-world open pilot will provide feedback to help tailor the intervention to the OnTrackNY setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: August 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

Inclusion Criteria for EIS participants:

• Ages 16 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (International Classification of Disease Clinical Modification (ICD-10-CM) Diagnosis Code F20.x)

• Receive First Episode Psychosis (FEP) treatment in one of OnTrackNY clinics/sites with an eligible EIS clinicians

• Willing to participate in research interviews after each study visit during the study period

Exclusion Criteria:

• Unable to provide informed consent

• Not fluent (speaking, reading, writing) in English

Related Conditions & MeSH terms

• Delusional Disorder
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders
• Schizophrenia, Paranoid
• Schizophreniform Disorders

Intervention

Behavioral:
• adapted behavioral intervention
cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Acceptability of Intervention Measure (AIM)	The AIM is a 4-item measure of the acceptability of the intervention, to be completed by EIS clinicians. Scores range from 1-4 with higher score indicating high acceptability.	12 weeks
Primary	Mean Feasibility of Intervention Measure (FIM)	The FIM is a 4-item measure of the feasibility of the intervention, to be completed by EIS clinicians. Scores range from 1-4 with higher score indicating high feasibility.	12 weeks
Primary	Number of EIS Participants in Attendance	The number of EIS participants that attend the cognitive behavioral therapy sessions.	12 weeks