Clinical trial NCT03970005: Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
Official title: Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prodromal Schizophrenia
Keywords: psychosis
treatment
clinical high-risk
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2019-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This program evaluation will include all patients referred to The OSU EPICENTER CHR-P clinical program.

Brief summary: The Ohio State University Early Psychosis Intervention Center is implementing a specialized clinical program to serve individuals who meet clinical high risk criteria for a psychosis. The purpose of this study is to evaluate the long-term outcomes among individuals participating in this clinical service.

Detailed description: The Ohio State University Early Psychosis Intervention Center (OSU EPICENTER) is implementing a specialized clinical program to serve individuals ages 12-25 who meet clinical high risk criteria for a psychosis (CHR-P). The purpose of this project is to evaluate (i) correlates of baseline characteristics among clinic participants; (ii) outcomes among individuals participating in this clinical service; and (iii) predictors and mediators of longitudinal outcomes among individuals participating in this clinical service.

Eligibility criteria: Inclusion Criteria:

* Male and female patients between ages 12-25
* Individuals meeting clinical high-risk criteria for psychosis as determined using the Structured Interview for Psychosis Risk. Inclusive of individuals meeting any of the three CHR syndromes assessed by the SIPS (i.e., attenuated psychotic symptoms; brief intermittent psychosis, and genetic risk and functional deterioration) and/or individuals at all four current status specifiers for the SIPS (i.e., progression, persistence, partial remission, and full remission) given evidence that future worsening of symptoms and/or progression to psychosis is possible for individuals in each current status specifier category.
* Subjects with no evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4
* Fluent in English per self-report

Primary outcomes:
measure: Time to remission of clinical-high risk status for psychosis
timeFrame: Remission status assessed at all treatment visits which will occur approximately once every week for up to 104 weeks
Secondary outcomes:
measure: Change from baseline in quality of life assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change in from baseline in cognitive functioning assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in suicidality assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in substance use severity assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in anxiety assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in depressed mood assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in symptomatology assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in social functioning assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in role functioning assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in service utilization assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in medication adherence assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in experience of trauma assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in health-related quality of life assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Other outcomes:
measure: Change from baseline in capability for suicide/lethal self-injury assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in beliefs about use of alcohol assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in beliefs about use of marijuana assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in recognition of predilection to common thinking errors assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in perceptions of core qualities of self and others assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in cognitive biases commonly experienced by individuals with psychosis assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in executive functioning assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in motor functioning assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in Body Mass Index (BMI) as assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in resting blood pressure as assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in resting pulse as assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in theory of mind assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in internalized stigma associated with a mental illness assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in experienced stigma associated with a mental illness assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in level of physical activity assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in perceived belongingness and perceived burdensomeness assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in insight into cognitive abilities assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in metacognition assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in use of tobacco products assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in symptomatology associated with Post Traumatic Stress Disorder assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in quality of socialization assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in referential thinking assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in perceptions of self, others, and personal agency assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in responsiveness in social interactions assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in sense of causation and personal agency assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in Big-5 personality traits assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in treatment motivation assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
measure: Change from baseline in loneliness assessed every six months for up to 24 months
timeFrame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Locations:
city: Columbus
country: United States
facility: OSU Harding Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: Nicholas Breitborde, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breitborde NJK, Guirgis H, Stearns W, Carpenter KM, Lteif G, Pine JG, Storey N, Wastler H, Moe AM. The Ohio State University Early Psychosis Intervention Center (EPICENTER) step-based care programme for individuals at clinical high risk for psychosis: study protocol for an observational study. BMJ Open. 2020 Jan 27;10(1):e034031. doi: 10.1136/bmjopen-2019-034031.