Psychotic DisordersDUPNCT02841956
Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
A study testing Electronic Screen + Education (Phase 1), Targeted Provider Education (Phase 1) and Community Mobile Engagement (Phase 2) in people with Psychotic Disorders, run by University of California, Davis at 1 site in United States.
Trial summary
Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term outcomes in young people with a first episode of psychosis (FEP). The "standard of FEP care" within the US focuses on targeted provider education regarding signs and symptoms of early psychosis to motivate patient referrals to FEP… Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Electronic Screen + Education (Phase 1), Targeted Provider Education (Phase 1) and Community Mobile Engagement (Phase 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet DSM-IV criteria for a diagnosis of affective or nonaffective psychosis.
Who cannot join
- Duration of psychosis > 2 years
- Current substance dependence
- Neurological illness or injury leading to psychotic symptoms
- Only substance induced psychotic symptoms
- Documented IQ < 70
- Lack of English fluency
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Early Diagnosis and Preventative Treatment (EDAPT) Clinic
Sacramento, California, 95817
About this study
Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term outcomes in young people with a first episode of psychosis (FEP). The "standard of FEP care" within the US focuses on targeted provider education regarding signs and symptoms of early psychosis to motivate patient referrals to FEP services, followed by initiation of services within largely clinic-based settings Experience at the Early Diagnosis and Preventive Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two important bottlenecks to reducing DUP, consistent with reports in the literature from other FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building upon a comprehensive and established referral network of 20 sites across the Sacramento area (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the investigators will address delays in patient identification and engagement using a two-phase, cluster randomized design. The investigators will consecutively test the impact of two interventions to reduce DUP, defined in this RFA as time from first onset of psychotic symptoms to engagement in FEP specialty care. To address identification delays, the investigators will examine the use of standard targeted provider education plus novel technology-enhanced screening compared to standard targeted provider education alone, testing the hypothesis that the education plus technology-enhanced screening will identify more patients, earlier in their illness. To address engagement delays, the investigators will compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to standard clinic-based procedures for intake, engagement and initiation of treatment, to test the hypothesis that the mobile approach facilitates earlier and more stable engagement, thereby reducing DUP. The proposed work will provide new specific evidence-based practices for reducing DUP and improving outcomes through specialty care of individuals with a first episode of psychosis.
- Conditions
- Psychotic Disorders
- Being tested
- Electronic Screen + Education (Phase 1), Targeted Provider Education (Phase 1), Community Mobile Engagement (Phase 2), Clinic based Engagement (Phase 2)
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Screen + Education (Phase 1)Other
PHASE 1 Electronic Screening Arm + Targeted Education: Referral sources will receive the same standard targeted education as active comparator. In addition, the PQ-B (a 21 item screening questionnaire) will be administered to all patients at their first visit to the referral sites (e.g. intake) via an android tablet provided to the site for ease of administration and scoring. The investigators will provide multiple tablets per site so that the screening is available for more than one individual simultaneously and can be completed in any appropriate location. The investigators will allow paper-and-pencil administration for situations where it is more appropriate (e.g. emergency room).
Targeted Provider Education (Phase 1)Other
PHASE 1 Targeted Education Intervention: EDAPT standard targeted provider education1 focuses on increasing awareness about the signs of early psychosis \& building collaborative relationships with community members so community members see EDAPT as a rapid, effective source of help. It consists of a 2-hour workshop describing: 1) how to identify specific early symptoms \& changes associated with the onset of psychotic illness, 2) the benefits of early intervention on treatment outcomes in psychosis, 3) the structure, philosophy \& treatment model of the EDAPT Clinic, and 4) procedures for expeditious referral to our program. Case-based vignettes are reviewed to ensure understanding of the key symptoms.
Community Mobile Engagement (Phase 2)Other
PHASE 2 Community-based Mobile Engagement: Clinical assessment appointments will take place at the EDAPT clinic or within the community, wherever the individual would prefer. With patients deemed eligible for EDAPT services, the EDAPT clinician will obtain vitals and contact the EDAPT psychiatrist with a telemedicine-enabled laptop to complete the psychiatric evaluation remotely. The psychiatrist will prescribe medications and order labs, as indicated. The EDAPT clinician will follow up with the individual within 5 days to determine if the prescribed medication regimen has started.
Clinic based Engagement (Phase 2)Other
PHASE 2 Clinic-based Engagement: The clinical assessment appointment will be completed within the EDAPT clinic. If deemed eligible for EDAPT services, the individual will be scheduled for a clinic-based appointment with the EDAPT psychiatrist within 5 days, who will prescribe medications and order labs as indicated. The EDAPT clinician will follow up with the individual within 5 days of the psychiatric evaluation (by phone or in the clinic) to determine if the prescribed medication regimen has started.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Screen + Education (Phase 1) | Experimental | Electronic screening of participants and targeted education of providers according to standard EDAPT model. Receives: Other: Electronic Screen + Education (Phase 1) |
| Targeted Provider Education (Phase 1) | Active comparator | Targeted education of providers according to standard EDAPT model. Receives: Other: Targeted Provider Education (Phase 1) |
| Community Mobile Engagement (Phase 2) | Experimental | Clinical intake interviews take place via videoconference at a location in the community convenient for the participant. Receives: Other: Community Mobile Engagement (Phase 2) |
| Clinic based Engagement (Phase 2) | Active comparator | Clinical intake interviews take place at the EDAPT clinic. Receives: Other: Clinic based Engagement (Phase 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of active psychosis between onset of illness and identification for care (Duration of untreated psychosis)
Measured: Day 1
Secondary outcomes (1)
Rates of patient enrollment in first episode psychosis care
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startSep 2014
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841956
- Sponsor's protocol ID
- 608950
- Other IDs
- R01MH104235
- Acronym
- DUP
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2016
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Niendam TA, Loewy R, Savill M, Delucchi KL, Lesh TA, Ragland JD, Bolden K, Skymba HV, Gobrial S, Meyer MS, Pierce KM, Rosenthal A, Fedechko TL, Tully LM, Tryon VL, Goldman H, Cress RD, Kravitz RL, Carter CS. Effect of Technology-Enhanced Screening in Addition to Standard Targeted Clinician Education on the Duration of Untreated Psychosis: A Cluster Randomized Clinical Trial. JAMA Psychiatry. 2023 Feb 1;80(2):119-126. doi: 10.1001/jamapsychiatry.2022.4436.
PubMed 36598770
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
- ClinicalTrials.gov ID
- NCT02841956
- Acronym / sponsor ID
- DUP / 608950
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 427 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2014
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term outcomes in young people with a first episode of psychosis (FEP). The "standard of FEP care" within the US focuses on targeted provider education regarding signs and symptoms of early psychosis to motivate patient referrals to FEP services, followed by initiation of services within largely clinic-based settings Experience at the Early Diagnosis and Preventive Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two important bottlenecks to reducing DUP, consistent with reports in the literature from other FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building upon a comprehensive and established referral network of 20 sites across the Sacramento area (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the investigators will address delays in patient identification and engagement using a two-phase, cluster randomized design. The investigators will consecutively test the impact of two interventions to reduce DUP, defined in this RFA as time from first onset of psychotic symptoms to engagement in FEP specialty care. To address identification delays, the investigators will examine the use of standard targeted provider education plus novel technology-enhanced screening compared to standard targeted provider education alone, testing the hypothesis that the education plus technology-enhanced screening will identify more patients, earlier in their illness. To address engagement delays, the investigators will compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to standard clinic-based procedures for intake, engagement and initiation of treatment, to test the hypothesis that the mobile approach facilitates earlier and more stable engagement, thereby reducing DUP. The proposed work will provide new specific evidence-based practices for reducing DUP and improving outcomes through specialty care of individuals with a first episode of psychosis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Electronic Screen + Education (Phase 1) | Experimental | Other: Electronic Screen + Education (Phase 1)Electronic screening of participants and targeted education of providers according to standard EDAPT model. |
| Targeted Provider Education (Phase 1) | Active comparator | Other: Targeted Provider Education (Phase 1)Targeted education of providers according to standard EDAPT model. |
| Community Mobile Engagement (Phase 2) | Experimental | Other: Community Mobile Engagement (Phase 2)Clinical intake interviews take place via videoconference at a location in the community convenient for the participant. |
| Clinic based Engagement (Phase 2) | Active comparator | Other: Clinic based Engagement (Phase 2)Clinical intake interviews take place at the EDAPT clinic. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Meet DSM-IV criteria for a diagnosis of affective or nonaffective psychosis.
Key exclusion criteria (6 listed)
- Duration of psychosis > 2 years
- Current substance dependence
- Neurological illness or injury leading to psychotic symptoms
- Only substance induced psychotic symptoms
- Documented IQ < 70
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 |
|---|---|---|
| Electronic Screen + Education (Phase 1)PHASE 1 Electronic Screening Arm + Targeted Education: Referral sources will receive the same standard targeted education as active comparator. In addition, the PQ-B (a 21 item screening questionnaire) will be administered to all patients at their first visit to the referral sites (e.g. intake) via an android tablet provided to the site for ease of administration and scoring. The investigators will provide multiple tablets per site so that the screening is available for more than one individual simultaneously and can be completed in any appropriate location. The investigators will allow paper-and-pencil administration for situations where it is more appropriate (e.g. emergency room). | Other | Electronic Screen + Education (Phase 1) |
| Targeted Provider Education (Phase 1)PHASE 1 Targeted Education Intervention: EDAPT standard targeted provider education1 focuses on increasing awareness about the signs of early psychosis \& building collaborative relationships with community members so community members see EDAPT as a rapid, effective source of help. It consists of a 2-hour workshop describing: 1) how to identify specific early symptoms \& changes associated with the onset of psychotic illness, 2) the benefits of early intervention on treatment outcomes in psychosis, 3) the structure, philosophy \& treatment model of the EDAPT Clinic, and 4) procedures for expeditious referral to our program. Case-based vignettes are reviewed to ensure understanding of the key symptoms. | Other | Targeted Provider Education (Phase 1) |
| Community Mobile Engagement (Phase 2)PHASE 2 Community-based Mobile Engagement: Clinical assessment appointments will take place at the EDAPT clinic or within the community, wherever the individual would prefer. With patients deemed eligible for EDAPT services, the EDAPT clinician will obtain vitals and contact the EDAPT psychiatrist with a telemedicine-enabled laptop to complete the psychiatric evaluation remotely. The psychiatrist will prescribe medications and order labs, as indicated. The EDAPT clinician will follow up with the individual within 5 days to determine if the prescribed medication regimen has started. | Other | Community Mobile Engagement (Phase 2) |
| Clinic based Engagement (Phase 2)PHASE 2 Clinic-based Engagement: The clinical assessment appointment will be completed within the EDAPT clinic. If deemed eligible for EDAPT services, the individual will be scheduled for a clinic-based appointment with the EDAPT psychiatrist within 5 days, who will prescribe medications and order labs as indicated. The EDAPT clinician will follow up with the individual within 5 days of the psychiatric evaluation (by phone or in the clinic) to determine if the prescribed medication regimen has started. | Other | Clinic based Engagement (Phase 2) |
Primary outcome
Days of active psychosis between onset of illness and identification for care (Duration of untreated psychosis)
Time frame: Day 1
1 secondary outcome
Rates of patient enrollment in first episode psychosis care
Time frame: Baseline
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Derived from this study: PubMed 36598770Niendam TA, Loewy R, Savill M, Delucchi KL, Lesh TA, Ragland JD, Bolden K, Skymba HV, Gobrial S, Meyer MS, Pierce KM, Rosenthal A, Fedechko TL, Tully LM, Tryon VL, Goldman H, Cress RD, Kravitz RL, Carter CS. Effect of Technology-Enhanced Screening in Addition to Standard Targeted Clinician Education on the Duration of Untreated Psychosis: A Cluster Randomized Clinical Trial. JAMA Psychiatry. 2023 Feb 1;80(2):119-126. doi: 10.1001/jamapsychiatry.2022.4436.
- UC Davis Early Psychosis ProgramsLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Screen + Education (Phase 1), Targeted Provider Education (Phase 1) and Community Mobile Engagement (Phase 2) in people with Psychotic Disorders, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Days of active psychosis between onset of illness and identification for care (Duration of untreated psychosis) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02841956, which also lists 1 linked publication.
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 25 Jun 2021.