Young Adults With Violent Behavior During Early Psychosis (Aim 2)

NCT ID: NCT05756855

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia Schizo Affective Disorder Schizophreniform Disorders Delusional Disorder Other Specified Schizophrenia Spectrum and Other Psychotic Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open pilot clinical trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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behavioral 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.

Group Type EXPERIMENTAL

adapted behavioral intervention

Intervention Type BEHAVIORAL

cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis

Interventions

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adapted behavioral intervention

cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis

Intervention Type BEHAVIORAL

Other Intervention Names

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PICASSO

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Paul S. Appelbaum

Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul S Appelbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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K23MH126312

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NYSPI 8451

Identifier Type: OTHER

Identifier Source: secondary_id

AAAU8528

Identifier Type: -

Identifier Source: org_study_id

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