Sustainable Early Episode Clinic Study (SEEC)

Not Applicable

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Behavioral: Sustainable Early Episode Clinic Model of Care

• Registration Number: NCT03571685
• Lead Sponsor: Janssen Scientific Affairs, LLC

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.

Study Timeline

• Study Start: 2017-01-31
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-27
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sustainable Early Episode Clinic Model of Care	Sustainable Early Episode Clinic Model of Care	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.

Primary Outcome Measures

Name	Time	Method
High Intensity Service Utilization Rate	Baseline up to 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Healthcare Utilization Rate	Baseline up to 36 months	Overall healthcare utilization rate that is count per unit of time of the healthcare resources which were utilized by the participants over over the time will be reported.
Change from Baseline in Clinician-Rated Dimensions of Psychosis Symptom and Severity (CRDPSS) Scale	Baseline up to 36 months	The CRDPSS is an 8 item measure that assesses the severity of mental health symptoms that are important across psychotic disorders including: Delusions, hallucinations, disorganized speech, abnormal psycho-motor behavior, negative symptoms, impaired cognition, depression and mania. Each item on the measure is rated on a 5 point scale with a symptom specific definition of each rating level: 0 = none, 1= equivocal, 2= present but mild, 3= present and moderate, 4= present and severe. Total Score is taken as summation. High score indicates worsening of symptoms.
Change from Baseline in Clinical Global Impressions Scale (CGI-S)	Baseline up to 36 months	The CGI-S measures illness severity and is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill participants).
Change from Baseline in Personal and Social Performance (PSP) Scale	Baseline up to 36 months	The PSP has 4 domains of functioning considered in this scale: (a) Socially useful activities including work and study, (b) Personal \& Social Relationships, (c) Self Care (d) Disturbing and aggressive behaviors. All rated from absent, mild, manifest, marked, severe and very severe. Scores of 1-30 reflect functioning so poor that the participant requires intensive support of supervision. 31-70 varying degree of difficulties 71-100 reflect only mild difficulties.
Change from Baseline in Perceived Family Burden Scale (PFBS)	Baseline up to 36 months	The purpose of the PFBS scale is to measure the burden of schizophrenia on the family of a participant. It is a 24-item questionnaire rated on a 5 point Likert type scale: 0 = the behavior isn't present and doesn't bother the relative, 1 = the behavior is present and doesn't bother the relative, 2 = the behavior is present and bothers the relative "a little", 3 = the behavior is present and bothers the relative "considerably", 4 = the behavior is present and bothers the relative "a great deal". High score indicates worsening of burden.
Heinrichs-Carpenter Quality of Life Scale (QLS)	Baseline up to 36 months	The QLS is used to evaluate defect symptoms and impaired functioning in non-hospitalized schizophrenic participants. It is a 21-item scale providing information on symptoms and functioning in the preceding 4 weeks. Each item is rated on 7 point scale. A sub scale score is being used in 4 sections ranging from 0-56. Low score represents worse functioning. Then a total score is taken by adding the 4 sections. Range of possible scores, 0-126. Lower sub scale scores and total scores indicates lower quality of life.

Trial Locations

Locations (1)

Sharp Outpatient Behavioral Health Clinic; 🇺🇸 San Diego, California, United States