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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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 groups in NCT05756855
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.

19 Mar 202413 Oct 2025

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)

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Young Adults With Violent Behavior During Early Psychosis: An Open Pilot Trial
ClinicalTrials.gov ID: NCT05756855
Acronym / sponsor ID: AAAU8528
Conditions: Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Delusional Disorder, Other Specified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords: psychosis, schizophrenia, violence, aggression, intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 19 Mar 2024 (actual)
Primary completion: 13 Oct 2025 (actual)
Study completion: 13 Oct 2025 (actual)
First posted: 6 Mar 2023 (actual)
Results: Posted 5 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: open pilot clinical trial

Arm	Type	Receives
behavioral intervention	Experimental	Behavioral: adapted behavioral interventionThis 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.

Who may qualify

Ages: 16 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Unable to provide informed consent
Not fluent (speaking, reading, writing) in English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
adapted behavioral interventionAlso: PICASSOcognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis	Behavioural	behavioral intervention

Primary outcome

Mean Acceptability of Intervention Measure (AIM)
Time frame: 12 weeks
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.
Mean Feasibility of Intervention Measure (FIM)
Time frame: 12 weeks
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.
Number of EIS Client Participants in Attendance
Time frame: 12 weeks
The number of EIS client participants that attend the cognitive behavioral therapy sessions.

Results and safety

Results posted to the registry on 5 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BRAVE Intervention - Clinician Participants	5	5
BRAVE Intervention - Client Participants	7	5

Primary outcome: Mean Acceptability of Intervention Measure (AIM)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	BRAVE Intervention - Clinician Participants n = 5
Value	4.69 (0.65)

Population analysed: Only clinicians were assessed for this outcome.

Primary outcome: Mean Feasibility of Intervention Measure (FIM)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	BRAVE Intervention - Clinician Participants n = 5
Value	4.65 (0.65)

Population analysed: Only clinicians were assessed for this outcome.

Primary outcome: Number of EIS Client Participants in Attendance

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	BRAVE Intervention - Client Participants n = 7
Value	7

Population analysed: Only clients were assessed for this outcome.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BRAVE Intervention - Clinician Participants	0 of 5 (0%)	0 of 5 (0%)	0 of 5
BRAVE Intervention - Client Participants	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
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Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul S Appelbaum, MD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing adapted behavioral intervention in people with Schizophrenia and Schizo Affective Disorder, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Acceptability of Intervention Measure (AIM) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05756855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.