Sustainable Early Episode Clinic Study (SEEC)

NCT03571685 | Completed

• 1 other identifier: 2017-08A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• High Intensity Service Utilization Rate

  The rate of high intensity service utilization that is count per unit of time for mental health services will be reported. It is evaluated as the number of psychiatric hospitalizations, behavioral health emergency department visits, and number of times referred to a partial hospitalization program (PHP), intensive outpatient program (IOP), or Crisis Unit.

  Baseline up to 36 months

Secondary Outcomes (6)

• Overall Healthcare Utilization Rate

  Baseline up to 36 months

• Change from Baseline in Clinician-Rated Dimensions of Psychosis Symptom and Severity (CRDPSS) Scale

  Baseline up to 36 months

• Change from Baseline in Clinical Global Impressions Scale (CGI-S)

  Baseline up to 36 months

• Change from Baseline in Personal and Social Performance (PSP) Scale

  Baseline up to 36 months

• Change from Baseline in Perceived Family Burden Scale (PFBS)

  Baseline up to 36 months

Study Arms (1)

Sustainable Early Episode Clinic Model of Care

EXPERIMENTAL

The model of care given in the sustainable early episode clinic study, provides early intense intervention, with an ongoing maintenance phase in an outpatient setting.

Behavioral: Sustainable Early Episode Clinic Model of Care

Interventions

Sustainable Early Episode Clinic Model of Care BEHAVIORAL

The first 8 weeks is the education phase. Participants attend classes every week for up to 6 hours. From 9 weeks to 10 months participants attend classes for 5 hours every other week. Based on individual progress. Participants can move to the maintenance phase. This phase provides minimal intervention but ongoing support/evaluation.

Sustainable Early Episode Clinic Model of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (1)

Sharp Outpatient Behavioral Health Clinic

San Diego, California, 92105, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: June 27, 2018
• Study Start: January 31, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)