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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH126312 | U.S. NIH Grant/Contract | View source | |
| NYSPI 8451 | Other Identifier | New York State Psychiatric Institute Institutional Review Board |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapted behavioral intervention | Behavioral | cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Number of EIS Participants in Attendance | The number of EIS participants that attend the cognitive behavioral therapy sessions. | 12 weeks |
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Inclusion Criteria for EIS participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S Appelbaum, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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.
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Descriptive and raw data will be submitted on an annual basis. Unpublished de-identified data will be shared within one year after project completion, or when the data are published, whichever is earlier.
Data and materials will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories, including the National Database for Clinical Trials related to Mental Illness (NDCT) and the National Institute of Mental Health (NIMH) Database of Cognitive Training and Remediation Studies (DoCTRS).
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D012563 | Schizophrenia, Paranoid |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
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open pilot clinical trial
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| D001519 | Behavior |
| D012919 | Social Behavior |