PsychosisNCT03983421
Feasibility of an Early Detection Program for Early Psychosis on a College Campus
An observational study of Psychosis and First Episode Psychosis, run by University of New Mexico at 1 site in United States.
Trial summary
The objective of the proposed study is to determine the feasibility of an Early Detection program that aims to: (i) identify college students at clinical high risk (CHR) of psychosis or with first episode psychosis (FEP), and (ii) efficiently link them to coordinated specialty care (CSC) services for a 2nd stage… Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, First Episode Psychosis, Clinical High Risk for Psychosis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2022
- Phase
- Observational
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study sample includes students enrolled in the University of New Mexico (UNM), Department of Psychiatry and Behavioral Health Sciences CSC program. At the time of the study, the UNM CSC Program included separate clinics for patients diagnosed with clinical high risk for psychosis (CHRp) or FEP.
Who may be able to join
- 15-30 year-old college students who present to the University of New Mexico (UNM) Early Program or the UNM CONNECT program for an intake,
- screen positive for clinical high risk on the Structured Interview for Prodromal Syndromes (SIPS) or first episode psychosis on the Structured Clinical Interview for Diagnostic Statistical Manual IV
- agree to participate in the study.
Who cannot join
- below the age of 15 years old or above the age of 30,
- not UNM college students,
- screen negative for clinical high risk or first episode psychosis,
- refuse to participate in the study,
- cognitively unable to provide informed consent as demonstrated by a brief cognitive screen prior to completion of the enrollment interview
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
The objective of the proposed study is to determine the feasibility of an Early Detection program that aims to: (i) identify college students at clinical high risk (CHR) of psychosis or with first episode psychosis (FEP), and (ii) efficiently link them to coordinated specialty care (CSC) services for a 2nd stage screen, a clinical assessment, and appropriate treatment. The study will also determine pathways to care and perceived barriers to care among those students enrolled in Coordinated Specialty Care.
Read the detailed description
Long duration of untreated psychosis (DUP) is associated with poor outcomes, including higher rates of suicide, hospitalization, and overall low functioning. More widespread use of effective strategies to decrease DUP are needed to address the substantial discrepancy between the actual (i.e., on average 2 years) and recommended time (i.e., 3 months) between the appearance of psychotic symptoms and the initiation of treatment. Early detection (ED) programs aim to decrease DUP by increasing case identification and removal of barriers to coordinated specialty care (CSC). The most studied components of ED programs include: (i) educational campaigns; ED response teams designed to optimize the referral processes to CSC; and to a lesser extent, screening among high-risk groups. While results of studies on individual ED components have been inconsistent, combinations of ED components have had more success in reducing DUP. For example, the Treatment and Intervention in Psychosis ED program, which included educational campaigns and ED teams, reported an average decrease in DUP from 1.5 years to 0.5 years pre-post implementation. The evidence on community-based ED programs is large and growing but very little is known about the effectiveness of ED services on college campuses in the United States. This gap in the literature is problematic because, with the first symptoms of psychosis being most likely to surface among college age young adults, college campuses are critical locations to identify and refer individuals to CSC who are at increased risk of first episode psychosis (FEP). The investigators aim to address this gap in the literature.
The long-term goal of this program of research is to improve clinical and functional outcomes among college students with early stages of psychosis by reducing DUP. The objective of the proposed study is to determine the feasibility of an ED program that aims to: (i) identify college students at CHR of psychosis or with FEP, and (ii) efficiently link them to CSC services for a 2nd stage screen and a clinical assessment among those determined eligible. Students will be referred to treatment based on the results of the assessment (the University of New Mexico Department of Psychiatry CSC program includes clinical services for both FEP and CHR).
The study will also determine pathways to care and perceived barriers to care among those students enrolled in Coordinated Specialty Care.
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Students Enrolled In Coordinated Specialty Care | The number of students determined eligible for Coordinated Specialty Care that were originally screened through the PQ-B at the college counseling center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Untreated Psychosis
Duration of Untreated Psychosis determined upon enrollment to coordinated specialty care
Measured: Measured upon admission (baseline) to coordinated specialty care (CSC)
Secondary outcomes (2)
Number of Steps to Coordinated Specialty Care
Measured among those who meet criteria for first episode psychosis or clinical high risk using the Circumstances of Onset and Relapse Schedule, and is operationalized as the number of steps between the onset of symptoms and admission to CSC for first episode psychosis or clinic high risk. The CORS includes the Topography of Psychotic Episode (TOPE), which traces the process of seeking treatment by identifying step-by-step contacts with medical, mental health, and/or community services in the pathway toward enrollment in CSC. Participants were asked if they had ever sought out a particular service or professional for mental health problems, and if so, the approximate date of that encounter.
Measured: Measured upon admission (baseline) to coordinated specialty care (CSC)
Perceived Barriers to Seeking Psychological Help
Measured among those who meet criteria for first episode psychosis or clinical high risk by the Barriers to Seeking Psychological Help Scale (BSPHS), developed to measure barriers related to psychological help-seeking for college students. The self-report scale includes 17 items rated on a five point scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The scale includes five subscales: (1) fear of being stigmatized by society, (2) trust in the mental health professional, (3) difficulties in self-disclosure, (4) perceived devaluation, and, (5) lack of knowledge. BSPHS total score and scores for all subscales are determined by taking the mean of responses to all items for the entire scale and the mean of responses for each subscale, respectively. Higher scores indicate higher perceived barriers for the entire scale and all subscales.
Measured: Measured upon admission (baseline) to coordinated specialty care (CSC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Annette Crisanti, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983421
- Sponsor's protocol ID
- 19-174
- Other IDs
- 1R34MH120777-01
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2019
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norman R, Malla A. Course of Onset and Relapse Schedule: Interview and Coding Instruction Guide.; 2002. Prevention and Early Intervention for Psychosis Program. Available from author.
Topkaya N, Sahin E, Meydan B. The Development, Validity, and Reliability of the Barriers to Seeking Psychological Help Scale for College Students. Int J High Educ. 2017;6(1):48-62.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Early Detection Program for Early Psychosis on a College Campus
- ClinicalTrials.gov ID
- NCT03983421
- Acronym / sponsor ID
- 19-174
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the proposed study is to determine the feasibility of an Early Detection program that aims to: (i) identify college students at clinical high risk (CHR) of psychosis or with first episode psychosis (FEP), and (ii) efficiently link them to coordinated specialty care (CSC) services for a 2nd stage screen, a clinical assessment, and appropriate treatment. The study will also determine pathways to care and perceived barriers to care among those students enrolled in Coordinated Specialty Care.
Detailed description
Long duration of untreated psychosis (DUP) is associated with poor outcomes, including higher rates of suicide, hospitalization, and overall low functioning. More widespread use of effective strategies to decrease DUP are needed to address the substantial discrepancy between the actual (i.e., on average 2 years) and recommended time (i.e., 3 months) between the appearance of psychotic symptoms and the initiation of treatment. Early detection (ED) programs aim to decrease DUP by increasing case identification and removal of barriers to coordinated specialty care (CSC). The most studied components of ED programs include: (i) educational campaigns; ED response teams designed to optimize the referral processes to CSC; and to a lesser extent, screening among high-risk groups. While results of studies on individual ED components have been inconsistent, combinations of ED components have had more success in reducing DUP. For example, the Treatment and Intervention in Psychosis ED program, which included educational campaigns and ED teams, reported an average decrease in DUP from 1.5 years to 0.5 years pre-post implementation. The evidence on community-based ED programs is large and growing but very little is known about the effectiveness of ED services on college campuses in the United States. This gap in the literature is problematic because, with the first symptoms of psychosis being most likely to surface among college age young adults, college campuses are critical locations to identify and refer individuals to CSC who are at increased risk of first episode psychosis (FEP). The investigators aim to address this gap in the literature.
The long-term goal of this program of research is to improve clinical and functional outcomes among college students with early stages of psychosis by reducing DUP. The objective of the proposed study is to determine the feasibility of an ED program that aims to: (i) identify college students at CHR of psychosis or with FEP, and (ii) efficiently link them to CSC services for a 2nd stage screen and a clinical assessment among those determined eligible. Students will be referred to treatment based on the results of the assessment (the University of New Mexico Department of Psychiatry CSC program includes clinical services for both FEP and CHR).
The study will also determine pathways to care and perceived barriers to care among those students enrolled in Coordinated Specialty Care.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students Enrolled In Coordinated Specialty Care | – | –The number of students determined eligible for Coordinated Specialty Care that were originally screened through the PQ-B at the college counseling center. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study sample includes students enrolled in the University of New Mexico (UNM), Department of Psychiatry and Behavioral Health Sciences CSC program. At the time of the study, the UNM CSC Program included separate clinics for patients diagnosed with clinical high risk for psychosis (CHRp) or FEP.
Key inclusion criteria (3 listed)
- 15-30 year-old college students who present to the University of New Mexico (UNM) Early Program or the UNM CONNECT program for an intake,
- screen positive for clinical high risk on the Structured Interview for Prodromal Syndromes (SIPS) or first episode psychosis on the Structured Clinical Interview for Diagnostic Statistical Manual IV
- agree to participate in the study.
Key exclusion criteria (5 listed)
- below the age of 15 years old or above the age of 30,
- not UNM college students,
- screen negative for clinical high risk or first episode psychosis,
- refuse to participate in the study,
- cognitively unable to provide informed consent as demonstrated by a brief cognitive screen prior to completion of the enrollment interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of Untreated Psychosis
Time frame: Measured upon admission (baseline) to coordinated specialty care (CSC)
Duration of Untreated Psychosis determined upon enrollment to coordinated specialty care
2 secondary outcomes
Number of Steps to Coordinated Specialty Care
Time frame: Measured upon admission (baseline) to coordinated specialty care (CSC)
Perceived Barriers to Seeking Psychological Help
Time frame: Measured upon admission (baseline) to coordinated specialty care (CSC).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundNorman R, Malla A. Course of Onset and Relapse Schedule: Interview and Coding Instruction Guide.; 2002. Prevention and Early Intervention for Psychosis Program. Available from author.
- BackgroundTopkaya N, Sahin E, Meydan B. The Development, Validity, and Reliability of the Barriers to Seeking Psychological Help Scale for College Students. Int J High Educ. 2017;6(1):48-62.
- 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.
Annette Crisanti, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and First Episode Psychosis, run by University of New Mexico 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 1 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2024). 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?
Duration of Untreated Psychosis (time frame: Measured upon admission (baseline) to coordinated specialty care (CSC)). 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 NCT03983421, which also lists 2 linked publications.
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 1 Apr 2024.