Feasibility of an Early Detection Program for Early Psychosis on a College Campus

Psychosis Clinical Trial

Official title:

Feasibility of an Early Detection Program for Early Psychosis on a College Campus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983421
• Other study ID #: 19-174
• Secondary ID: 1R34MH120777-01
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

1. 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,

2. 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

3. agree to participate in the study.

Exclusion Criteria:

1. below the age of 15 years old or above the age of 30,

2. not UNM college students,

3. screen negative for clinical high risk or first episode psychosis,

4. refuse to participate in the study,

5. cognitively unable to provide informed consent as demonstrated by a brief cognitive screen prior to completion of the enrollment interview

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• First Episode Psychosis
• Mental Disorders
• Psychosis
• Psychotic Disorders

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Untreated Psychosis	Duration of Untreated Psychosis determined upon enrollment to coordinated specialty care	Measured upon admission (baseline) to coordinated specialty care (CSC)
Secondary	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 upon admission (baseline) to coordinated specialty care (CSC)
Secondary	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 upon admission (baseline) to coordinated specialty care (CSC).