SchizophreniaNCT03975400
Using Digital Media Advertising to Reduce the Duration of Untreated Psychosis
A study testing search engine advertisement campaign in people with Schizophrenia and First Episode Psychosis, run by Northwell Health at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia, First Episode Psychosis
- What is being tested?
- search engine advertisement campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2020to 31 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: All individuals searching online for information related to mental health
Exclusion Criteria: none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwell
Glen Oaks, New York, 11004
Northwell
Queens, New York, 11004
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, First Episode Psychosis
- Being tested
- search engine advertisement campaign
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
search engine advertisement campaignBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Campaign | No intervention | Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation. |
| Active Campaign | Active comparator | Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation. Receives: Behavioral: search engine advertisement campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the Duration of Untreated Psychosis
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.
Measured: 2 years
Secondary outcomes (1)
Rates of Referrals
Evaluate the effectiveness of a search engine ad campaign on rates of referrals by directly comparing referrals pre-campaign to referrals during the campaign.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start22 Apr 2020
- Primary completion31 May 2022
- Study completion31 May 2023
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 Northwell HealthThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael L Birnbaum, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975400
- Sponsor's protocol ID
- 19-0266
- Other IDs
- 5R34MH120790-03
- Status last verified
- Oct 2023
- First submitted
- 30 May 2019
- Last updated
- 3 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Digital Media Advertising to Reduce the Duration of Untreated Psychosis
- ClinicalTrials.gov ID
- NCT03975400
- Acronym / sponsor ID
- 19-0266
- Conditions
- Schizophrenia, First Episode Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 3 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Campaign | No intervention | –Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation. |
| Active Campaign | Active comparator | Behavioral: search engine advertisement campaignInvestigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| search engine advertisement campaignThis 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. | Behavioural | Active Campaign |
Primary outcome
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.
1 secondary outcome
Rates of Referrals
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael L Birnbaum, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing search engine advertisement campaign in people with Schizophrenia and First Episode Psychosis, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 Nov 2023). 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?
Reducing the Duration of Untreated Psychosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2023.