Clinical trial NCT03571685: Sustainable Early Episode Clinic Study (SEEC)
Official title: A Prospective, Open Label, Quasi-Experimental Study of Adult Patients With Schizophrenia or Schizoaffective Disorder Within Five Years of Diagnosis Who Will Receive SEEC Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2018-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label, quasi-experimental study of adult patients with Schizophrenia or Schizoaffective Disorder within five years of diagnosis who are receiving SEEC intervention in phases. Approximately 50 patients will be enrolled in the study. Caregivers who would like to participate will also be included. Patients will be followed prospectively over the study period up to 36 months.
Primary purpose: OTHER

Brief summary: The purpose of this study is to describe relapse rates among participants receiving services in the SEEC program high intensity resource use. For purposes of this study, relapse will be defined as: Psychiatric hospitalization; Psychiatric emergency department visits; Ambulatory acute services (Partial Hospitalization Program, Intensive Outpatient Program, Crisis House stay).

Detailed description: Schizophrenia is a severe mental illness that is one of the leading causes of long-term disability in the world. Recognizing the need for improved early treatment for participants diagnosed with Schizophrenia or Schizoaffective Disorder, a model was created for a "sustainable early episode clinic, SEEC." The goal of the SEEC model is to provide early intense intervention in 3 phases, with an ongoing maintenance phase, enabled by technology, resulting in improved participant outcomes and reduced long-term economic and social burden of schizophrenia. This study will last for up to a 36-month period.

Eligibility criteria: Inclusion Criteria - Participants

* Participants must be at least 18 years or older
* Participants within 5 years of a clinical diagnosis of Schizophrenia or Schizoaffective disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for these disorders
* Participants must be able to speak, read, and understand English
* Participants must sign an informed consent form

Inclusion Criteria - Caregivers

* Caregivers must be 18 years or older Caregivers must also be willing to attend the multi-family psychoeducation group series (Phase I)
* Caregivers must be willing to participate in monthly family therapy and/or monthly phone contact with staff for the duration of the study
* Caregivers must sign informed consent form

Exclusion Criteria - Participants

* Co-occurring developmental disabilities
* Receiving electroconvulsive therapy
* Primary substance use disorder
* On permanent conservatorship
* Unable to complete baseline assessments due to acuity of psychiatric symptoms

Exclusion Criteria - Caregivers

* Caregivers who refuse to participate in the psychoeducation series of Phase 1
* Caregivers who refuse monthly family therapy/phone contact with staff will be excluded
* Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by treatment team
* Caregiver is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employee or the investigator

Primary outcomes:
measure: High Intensity Service Utilization Rate
timeFrame: Baseline up to 36 months
Secondary outcomes:
measure: Overall Healthcare Utilization Rate
timeFrame: Baseline up to 36 months
measure: Change from Baseline in Clinician-Rated Dimensions of Psychosis Symptom and Severity (CRDPSS) Scale
timeFrame: Baseline up to 36 months
measure: Change from Baseline in Clinical Global Impressions Scale (CGI-S)
timeFrame: Baseline up to 36 months
measure: Change from Baseline in Personal and Social Performance (PSP) Scale
timeFrame: Baseline up to 36 months
measure: Change from Baseline in Perceived Family Burden Scale (PFBS)
timeFrame: Baseline up to 36 months
measure: Heinrichs-Carpenter Quality of Life Scale (QLS)
timeFrame: Baseline up to 36 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Outpatient Behavioral Health Clinic
state: California
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: