SchizophreniaNCT05756855
Young Adults With Violent Behavior During Early Psychosis (Aim 2)
A study testing adapted behavioral intervention in people with Schizophrenia and Schizo Affective Disorder, run by Columbia University at 1 site in United States.
Trial summary
This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders
- What is being tested?
- adapted behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 13 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- Not fluent (speaking, reading, writing) in English
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Young Adults With Violent Behavior During Early Psychosis: An Open Pilot Trial
This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.
Read the 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.
- Conditions
- Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Delusional Disorder, Other Specified Schizophrenia Spectrum and Other Psychotic Disorder
- Being tested
- adapted behavioral intervention
- Keywords
- psychosis, schizophrenia, violence, aggression, intervention
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted behavioral interventionBehavioural
Also called PICASSO
cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis
| Study group | Role | What they receive |
|---|---|---|
| behavioral intervention | Experimental | 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. Receives: Behavioral: adapted behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Acceptability of Intervention Measure (AIM)
The AIM is a 5-item measure of the acceptability of the intervention, to be completed by EIS clinicians. Scores range from 1-5 with higher score indicating high acceptability.
Measured: 12 weeks
Mean Feasibility of Intervention Measure (FIM)
The FIM is a 5-item measure of the feasibility of the intervention, to be completed by EIS clinicians. Scores range from 1-5 with higher score indicating high feasibility.
Measured: 12 weeks
Number of EIS Client Participants in Attendance
The number of EIS client participants that attend the cognitive behavioral therapy sessions.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start19 Mar 2024
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open pilot clinical trial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Paul S Appelbaum, Columbia University
- Investigators
- Paul S Appelbaum, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756855
- Sponsor's protocol ID
- AAAU8528
- Other IDs
- K23MH126312, NYSPI 8451
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2023
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Findings from this study will be presented to research peers, clinicians, and the public through Presentations at Scientific Meetings, Regional Research or Educational Meetings, Newsletters and Social Media and Peer-Reviewed Publications. Those events will occur during or at the conclusion of the study.