Using Digital Media Advertising to Reduce the Duration of Untreated Psychosis

October 12, 2023 updated by: Northwell Health
There is compelling evidence that longer duration of untreated psychosis independently predicts negative outcomes. The proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State. Results from this initiative will be critical to informing the subsequent design and conduct of larger, focused, and proactive digital media campaigns targeting patient with First Episode Psychosis and their caregivers online, intended to accelerate linkage to care and reduce the duration of untreated psychosis throughout the U.S.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Approximately 100,000 individuals in the Unites States experience a first episode of psychosis (FEP) each year. Psychotic symptoms typically emerge during formative years of adolescence and young adult development and interfere with the establishment of healthy educational, vocational, and social foundations. Despite the severity of symptoms and significant decline in functioning, the time between symptom onset and receiving appropriate care in the U.S. is alarmingly lengthy. Longer Duration of Untreated Psychosis (DUP) has been shown to independently predict negative outcomes, including poorer response to treatment, worse global, vocational, social, and cognitive functioning, greater risk of relapse, higher symptom severity, and poorer quality of life. Prior successful DUP reduction initiatives have utilized various marketing strategies to educate the community about early intervention services, however these strategies are expensive, inefficient, and outdated. Targeted online outreach, supported by technological innovation, offers the prospect of proactively reaching individuals earlier in the course of illness development, as well as individuals who might not otherwise come into contact with traditional referral sources. In response to this challenge, Northwell Health's early psychosis research team is collaborating with Strong365, a nonprofit initiative dedicated to raising early psychosis intervention awareness, to develop and test a proactive and targeted comprehensive digital media marketing campaign designed to facilitate help-seeking and encourage treatment initiation in prospective patients with FEP and their caregivers. Investigators will take advantage of search engine advertisements, which allow advertisers (researchers) to select keywords/phrases and create linked ads appearing as a strategically placed search result. Dedicated ads will appear in response to online search queries conducted by prospective patients and their caregivers throughout New York State (NYS) that align with the campaign's pre-selected keywords/phrases. Individuals who click on the ads will be immediately directed to a landing page/website, and offered a variety of innovative and interactive online engagement tools intended to instantly connect users with specialty care staff and to facilitate earlier treatment initiation. Campaign referrals will be centralized and individuals with FEP will be enrolled into OnTrackNY (OTNY), a network of 21 dedicated early psychosis intervention programs throughout NYS. The campaign will target individuals as well as their caregivers, searching for psychosis-related terms or information online. Investigators will measure the DUP of individuals enrolled into OTNY before and after campaign activation and track the impact of the campaign on the number of FEP referrals and number of patients admitted to OTNY in NYS. Furthermore, investigators aim to identify the campaign target audience most effective at promoting treatment initiation as well as the online tools and resources most effective at encouraging treatment initiation for individuals with FEP. Investigators will additionally explore the online trajectories to care of individuals with FEP engaging with the campaign.

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 (Actual)

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.
698

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 Locations

  • United States
    • New York
      • Glen Oaks, New York, United States, 11004
        • NorthWell
      • Queens, New York, United States, 11004
        • NorthWell

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: All individuals searching online for information related to mental health

Exclusion Criteria: none

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: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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.
No Intervention: Pre-Campaign
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation.
Active Comparator: Active Campaign
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation.
Behavioral: search engine advertisement campaign
This proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State.

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
Reducing the Duration of Untreated Psychosis
Time Frame: 2 years
Evaluate the effectiveness of a search engine ad campaign on reducing the duration of untreated psychosis (DUP) by directly comparing DUP pre-campaign to DUP during the campaign.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rates of Referrals
Time Frame: 2 years
Evaluate the effectiveness of a search engine ad campaign on rates of referrals by directly comparing referrals pre-campaign to referrals during the campaign.
2 years

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.
Northwell Health

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.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael L Birnbaum, MD, Northwell Health

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 (Actual)

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.
April 22, 2020

Primary Completion (Actual)

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.
May 31, 2022

Study Completion (Actual)

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.
May 31, 2023

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).
May 30, 2019

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 3, 2019

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 5, 2019

Study Record Updates

Last Update Posted (Estimated)

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.
November 3, 2023

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.
October 12, 2023

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.
October 1, 2023

More Information

Terms related to this study

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.
  • 19-0266
  • 5R34MH120790-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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