Shared Decision Making for Antipsychotic Medications

March 24, 2026 updated by: Lisa Dixon, New York State Psychiatric Institute

Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yaara Zisman-llani, MA, PhD
  • Phone Number: 215-204-8726
  • Email: yaara@temple.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 18 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 (ICD-10-CM Diagnosis Code F20.x)
  • Current/past experiences with antipsychotic medications (APM; e.g., currently taking any antipsychotic medication, stopped taking, or considering stopping).
  • Receive FEP treatment in one of OnTrackNY clinics/sites randomized to intervention or treatment as usual (TAU) - Willing to participate in research interviews after each APM visit during the study period (3 months)

Exclusion Criteria:

  • Unable to provide informed consent
  • No experience with APM
  • Not fluent (speaking, reading, writing) in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The Antipsychotic Medication Decision Aid (APM-DA) intervention clinics
Three pairs of comparable clinics (out of 22 clinics where OnTrackNY operates) based on the same region of the state and similar numbers of patients with similar demographic composition. One of each paired clinic is assigned to the intervention group by a blinded Co-I who will generate binary random variables.
Other: The Antipsychotic Medication Decision Aid (APM-DA)
The APM-DA intervention is the first and only International Patient Decision Aid Standards (IPDAS) approved shared decision making (SDM) decision aid intervention for Antipsychotic Medication decisions in psychiatric visits. The APM-DA intervention developed by the research team addresses a common issue among psychiatric care providers and patients that lies in the heart of pharmacotherapy - taking, tapering or stopping APM. The APM-DA has a print format and can be used online as a PDF. It includes a concise table describing what each option involves, its benefits, risks, and strategies to reduce risks. The intervention was developed in co-production with various stakeholders (patients, clinicians, service leadership, family members, researchers). Additional intervention materials are an evidence document to support the information and an APM side effects table.
No Intervention: Treatment As Usual (TAU) clinics
The other clinic of each of the three pairs will be assigned to TAU.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) (Primary)
Time Frame: Change in SDM from baseline (T0, measured after the first medication visit) to the next post medication visit/s (Tnext) and up to a period of 3 months follow-up (T2)
The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) is the only validated self-report measure for SDM in psychiatry/mental health. The SDM-Q-9-Psy includes 9 items ranging from 0 to 5, with higher scores indicating higher quality of the SDM process perceived by the patient. The SDM-Q-9-Psy will be first measured (baseline, T0) after the first medication visit and then after each medication visit throughout the study period, therefore there will be multiple post-visits or "Tnext".
Change in SDM from baseline (T0, measured after the first medication visit) to the next post medication visit/s (Tnext) and up to a period of 3 months follow-up (T2)
Intent to Attend and Complete Treatment Scale (Primary)
Time Frame: Change in OnTrackNY engagement from baseline (T0, measured at enrollment), after each post medication visit/s (Tnext), and at 3-month follow-up (T2 )
The Intent to Attend and Complete Treatment are two items that are part of the EPINET Core Assessment Battery (CAB) "Medication Side Effects and Treatment Adherence" core domain to assess engagement in CSC program (OnTrackNY). The score ranges from 0 to 9 for each item, with higher scores indicating higher intent to attend and complete treatment. Changes in the Intent to Attend will be measured after each medication visit throughout the study period, therefore there will be multiple post-visits or "Tnext".
Change in OnTrackNY engagement from baseline (T0, measured at enrollment), after each post medication visit/s (Tnext), and at 3-month follow-up (T2 )
Adherence Estimator (Primary)
Time Frame: Change in Adherence Estimator from baseline (T0, measured at enrollment), after each post-visit/s (Tnext), and at 3-month follow-up (T2 )
The Adherence Estimator is a three-item measure relies on client self-report. The Adherence Estimator focuses on perceived concerns about medications, perceived need for medications, and perceived affordability of medications. The Adherence Estimator is scored by adding up the total number of points in each item and can range from 0 (Low risk for adherence problems) to 36 (High risk for adherence problems). Changes in the Adherence Estimator will be measured after each medication visit throughout the study period, therefore there will be multiple post-visits or "Tnext".
Change in Adherence Estimator from baseline (T0, measured at enrollment), after each post-visit/s (Tnext), and at 3-month follow-up (T2 )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York State Psychiatric Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R34MH128497-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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 NIMH Database of Cognitive Training and Remediation Studies (DoCTRS).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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