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Young Adults With Violent Behavior During Early Psychosis

Sponsor
Columbia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05756855
Collaborator
National Institute of Mental Health (NIMH) (NIH)
16
Enrollment
1
Location
1
Arm
40
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: adapted behavioral intervention
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
open pilot clinical trialopen pilot clinical trial
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Young Adults With Violent Behavior During Early Psychosis: An Open Pilot Trial
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Acceptability of Intervention Measure (AIM) [12 weeks]

      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.

    2. Mean Feasibility of Intervention Measure (FIM) [12 weeks]

      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.

    3. Number of EIS Participants in Attendance [12 weeks]

      The number of EIS participants that attend the cognitive behavioral therapy sessions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York State Psychiatric Institute New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Stephanie Rolin, MD, MPH, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephanie A Rolin, MD, Assistant Professor of Psychiatry, Columbia University
    ClinicalTrials.gov Identifier:
    NCT05756855
    Other Study ID Numbers:
    • 8211
    • K23MH126312
    First Posted:
    Mar 6, 2023
    Last Update Posted:
    Mar 6, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stephanie A Rolin, MD, Assistant Professor of Psychiatry, Columbia University
    psychosis
    schizophrenia
    violence
    aggression
    intervention
    Additional relevant MeSH terms:
    Disease
    Schizophrenia
    Psychotic Disorders
    Mental Disorders
    Mood Disorders
    Schizophrenia Spectrum and Other Psychotic Disorders
    Schizophrenia, Paranoid

    Study Results

    No Results Posted as of Mar 6, 2023