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Development and evaluation of community-based program for recovery; Psychoeducation

Status Approved

First Submitted Date

2020/12/26
Registered Date

2021/01/12
Last Updated Date

2020/12/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005768
Unique Protocol ID	CNUH-2020-166
Public/Brief Title	Development and evaluation of community-based program for recovery; Psychoeducation
Scientific Title	Development and evaluation of community-based program for recovery; Psychoeducation
Acronym	COMPRESS: Psychoeducation (COMmunity-based Program for REcovery from Schizophrenia Study: Psychoeducation)
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CNUH-2020-166
Approval Date	2020-06-08
Institutional Review Board Name	Chonnam National University Hospital Institutional Review Board
Institutional Review Board Address	42, Jebong-ro, Dong-gu, Gwangju
Institutional Review Board Telephone	062-220-5257
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sung-Wan Kim
Title	Professor
Telephone	+82-62-220-6148
Affiliation	Chonnam National University Hospital
Address	Jaebongro 42, Donggu, Gwangju, Korea
Contact Person for Public Queries
Name	AnNa Jo
Title	Study Nurse
Telephone	+82-62-220-5270
Affiliation	Chonnam National University Hospital
Address	Jaebongro 42, Donggu, Gwangju, Korea
Contact Person for Updating Information
Name	Sung-Wan Kim
Title	Professor
Telephone	+82-62-220-6148
Affiliation	Chonnam National University Hospital
Address	Jaebongro 42, Donggu, Gwangju, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-10-30 Actual
Target Number of Participant	218
Primary Completion Date	2023-12-31 , Anticipated
Study Completion Date	2024-07-31 , Anticipated
Name of Study	Chonnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-10-30 ,
Recruitment Status by Participating Study Site 2
Name of Study	Jeonbuk National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-22 ,
Recruitment Status by Participating Study Site 3
Name of Study	Inje University Haeundae Paik Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	HC19C0316

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	1. Objective - To develop the evidence for effectiveness of psychoeducation on improving awareness of illness and adherence to medication in patients with schizophrenia spectrum disorder. 2. Background - Schizophrenia is a disease with heavy social burdens caused by frequent recurrences and chronic progression. One of the biggest causes of recurrence is non-adherence with medication and lack of self-responsible handling of the illness in patients with schizophrenia. In previous studies, it is reported that drug and symptom management education decreased the readmission rate. Therefore, psychoeducation is important to prevent recurrence. Thus, the present study aimed to conduct prospective comparative clinical trial of psychoeducation for patients with schizophrenia spectrum disorder. 3. Hypothesis - Psychoeducation would be effective on the Improving insight of illness and adherence to medication in patients with schizophrenia. 4. Clinical trial plan - Prospective clinical trial for 6 weeks and long-term follow-up study with waiting control list

Study Summary Information

Lay Summary

1. Objective
- To develop the evidence for effectiveness of psychoeducation on improving awareness of illness and adherence to medication in patients with schizophrenia spectrum disorder.

2. Background
- Schizophrenia is a disease with heavy social burdens caused by frequent recurrences and chronic progression. One of the biggest causes of recurrence is non-adherence with medication and lack of self-responsible handling of the illness in patients with schizophrenia. In previous studies, it is reported that drug and symptom management education decreased the readmission rate. Therefore, psychoeducation is important to prevent recurrence. Thus, the present study aimed to conduct prospective comparative clinical trial of psychoeducation for patients with schizophrenia spectrum disorder.

3. Hypothesis
- Psychoeducation would be effective on the Improving insight of illness and adherence to medication in patients with schizophrenia.

4. Clinical trial plan
- Prospective clinical trial for 6 weeks and long-term follow-up study with waiting control list

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	Non-RCT
Intervention Type	Behavioral
Intervention Description	6 session psychoeducation: understanding illness, medication, depression, suicide prevention, relapse prevention Weekly group program would be provided for 5 weeks. Another group is a control group with usual care, not receiving the intervention.
Number of Arms	2
Arm 1	Arm Label Psychoeducation
	Target Number of Participant 109
	Arm Type Experimental
	Arm Description 6 session psychoeducation: understanding illness, medication, depression, suicide prevention, relapse prevention Weekly group program would be provided for 5 weeks.
Arm 2	Arm Label Control (waiting-list)
	Target Number of Participant 109
	Arm Type No intervention
	Arm Description No intervention: Waiting-list control group not receiving psychoeducation program but usual care

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F20.9)Schizophrenia, unspecified schizophrenia spectrum and other psychotic disorders
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 15Year~60Year
	Description ① Aged between 15 and 60 ② schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, or depressive disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-fifth edition) diagnosis criteria with psychotic symptoms ③ Clinical Global Impression (CGI) score: 5 or less ④ Social and Occupational Functioning Assessment Scale (SOFAS) score: 41~80
Exclusion Criteria	① severe physical illness ② IQ 70 or less ③ severe reality impairment ④ CGI score: CGI 6 or higher ⑤ SOFAS score: 40 or less, or 81 or higher ⑥ inpatients ⑦ experience receiving psychoeducation
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Positive and Negative Syndrome Scale -brief & G12
Timepoint	screening, baseline, 6 weeks, 40 weeks, 2 year
Primary Outcome(s) 2
Outcome	Drug Attitude Inventory
Timepoint	baseline, 6 weeks, 40 weeks, 2 year
Primary Outcome(s) 3
Outcome	,Social and Occupational Functioning Scale
Timepoint	screening, baseline, 6 weeks, 40 weeks, 2 year
Secondary Outcome(s) 1
Outcome	HoNOS, Columbia Suicide Severity Rating Scale
Timepoint	baseline, 6 weeks, 40 weeks, 2 year
Secondary Outcome(s) 2
Outcome	Clinical Global Impression-Schizophrenia (CGI-SCH) & Clinical Global Impression-improvement
Timepoint	screening, baseline, 6 weeks, 40 weeks, 2 year
Secondary Outcome(s) 3
Outcome	Subjective Wellbeing under Neuroleptics
Timepoint	baseline, 6 weeks, 40 weeks, 2 year
Secondary Outcome(s) 4
Outcome	EuroQoL - 5D (EQ-5D)
Timepoint	baseline, 6 weeks, 40 weeks, 2 year
Secondary Outcome(s) 5
Outcome	Beck Cognitive Insight Scale
Timepoint	baseline, 6 weeks, 40 weeks
Secondary Outcome(s) 6
Outcome	Brief Resilience Scale
Timepoint	baseline, 6 weeks, 40 weeks

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2025. 8
Way of Sharing	To be made available at a later date (shalompsy@daum.net)

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