Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT05416658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2022-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision Making for Antipsychotic Medications
Sponsor:
New York State Psychiatric Institute
Organization:
Study Overview
Official Title:
Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.
Detailed Description:
The investigators will conduct a cluster RCT of the APM-DA intervention at 6 OnTrackNY clinics, with 3 clinics implementing APM-DA as part of their psychiatric visits and 3 randomized to serve as control offering treatment as usual (TAU). The planned sample size is 120 OnTrackNY clients with first episode psychosis (FEP). This real-world pilot cluster RCT will assess the feasibility of the APM-DA intervention in FEP care, providing the first evidence for the effectiveness of the APM-DA compared with TAU and understanding of the SDM intervention's mechanism of action.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: