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Sustainable Early Episode Clinic Study (SEEC) (SEEC)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sustainable Early Episode Clinic Model of Care
Sponsored by
Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Outpatient Behavioral Health Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sustainable Early Episode Clinic Model of Care

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Healthcare Utilization Rate
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
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)
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
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)
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)
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.

Full Information

First Posted
March 1, 2018
Last Updated
May 19, 2020
Sponsor
Janssen Scientific Affairs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03571685
Brief Title
Sustainable Early Episode Clinic Study (SEEC)
Acronym
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sustainable Early Episode Clinic Model of Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sustainable Early Episode Clinic Model of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
High Intensity Service Utilization Rate
Description
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.
Time Frame
Baseline up to 36 months
Secondary Outcome Measure Information:
Title
Overall Healthcare Utilization Rate
Description
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.
Time Frame
Baseline up to 36 months
Title
Change from Baseline in Clinician-Rated Dimensions of Psychosis Symptom and Severity (CRDPSS) Scale
Description
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.
Time Frame
Baseline up to 36 months
Title
Change from Baseline in Clinical Global Impressions Scale (CGI-S)
Description
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).
Time Frame
Baseline up to 36 months
Title
Change from Baseline in Personal and Social Performance (PSP) Scale
Description
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.
Time Frame
Baseline up to 36 months
Title
Change from Baseline in Perceived Family Burden Scale (PFBS)
Description
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.
Time Frame
Baseline up to 36 months
Title
Heinrichs-Carpenter Quality of Life Scale (QLS)
Description
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.
Time Frame
Baseline up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Sharp Outpatient Behavioral Health Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States

12. IPD Sharing Statement

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Sustainable Early Episode Clinic Study (SEEC)

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