Back to resultsPsychoeducation for Vietnamese Families With a Patient With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, psychoeducation, Vietnam
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizophrenia, based on ICD-10
- Receive in-patient treatment at hospital
- Length of schizophrenia less than 3 years.
- Treated 3 or less times for schizophrenia.
Exclusion Criteria:
- Mental retardation, or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled.
- Suicidal ideation
Sites / Locations
- Danang Psychiatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychoeducation
Control
Arm Description
3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
Family and patient do not receive psychoeducation, but still receive standard hospital services for schizophrenia.
Outcomes
Primary Outcome Measures
Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.
Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable. The Quality of Life Enjoyment and Satisfaction Questionnaire with patient-report is used at both timepoints.
Change from baseline (pre-treatment) at 6 months post-baseline in family-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.
Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable. The Quality of Life Enjoyment and Satisfaction Questionnaire with family-report is used at both timepoints.
Secondary Outcome Measures
Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
Change in stigma towards schizophrenia using an Analysis of Covariance with the baseline stigma towards schizophrenia as the covariate, the 6 month stigma towards schizophrenia assessment as the dependent variable, and treatment group as the independent variable. The Stigma Towards Schizophrenia with patient-report is used at both timepoints.
Change from baseline (pre-treatment) to 6 months post-baseline in family-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
Change in stigma towards schizophrenia using an Analysis of Covariance with the baseline stigma towards schizophrenia as the covariate, the 6 month stigma towards schizophrenia assessment as the dependent variable, and treatment group as the independent variable. The Stigma Towards Schizophrenia with family-report is used at both timepoints.
Patient-report for schizophrenia medication compliance, at 6 months post-baseline
Analysis of Variance on medication compliance as reported by the patient
Full Information
NCT ID
NCT02715349
First Posted
March 3, 2016
Last Updated
March 16, 2016
Sponsor
Danang Psychiatric Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02715349
Brief Title
Psychoeducation for Vietnamese Families With a Patient With Schizophrenia
Official Title
Psychoeducation for Vietnamese Families With a Patient With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danang Psychiatric Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Families with a patient with schizophrenia and the patient are randomly assigned to receive either a 3 session psychoeducation program, or no psychoeducation. Other treatment for schizophrenia and other mental illness are provided as usual.
Detailed Description
Families with a patient with schizophrenia and the patient are randomly assigned to receive either a 3 session psychoeducation program, or no psychoeducation. Other treatment for schizophrenia and other mental illness are provided as usual. The psychoeducation program focuses on: (a) explaining schizophrenia as a medical, biological illness, (b) the prognosis for schizophrenia (e.g., that it is possible to lead a normal life), and (c) what the family and patient can do to maximize the outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, psychoeducation, Vietnam
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychoeducation
Arm Type
Experimental
Arm Description
3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Family and patient do not receive psychoeducation, but still receive standard hospital services for schizophrenia.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
Primary Outcome Measure Information:
Title
Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.
Description
Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable. The Quality of Life Enjoyment and Satisfaction Questionnaire with patient-report is used at both timepoints.
Time Frame
baseline (pre-treatment). six months post-baseline.
Title
Change from baseline (pre-treatment) at 6 months post-baseline in family-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.
Description
Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable. The Quality of Life Enjoyment and Satisfaction Questionnaire with family-report is used at both timepoints.
Time Frame
baseline (pre-treatment). six months post-baseline.
Secondary Outcome Measure Information:
Title
Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
Description
Change in stigma towards schizophrenia using an Analysis of Covariance with the baseline stigma towards schizophrenia as the covariate, the 6 month stigma towards schizophrenia assessment as the dependent variable, and treatment group as the independent variable. The Stigma Towards Schizophrenia with patient-report is used at both timepoints.
Time Frame
baseline (pre-treatment). six months post-baseline.
Title
Change from baseline (pre-treatment) to 6 months post-baseline in family-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
Description
Change in stigma towards schizophrenia using an Analysis of Covariance with the baseline stigma towards schizophrenia as the covariate, the 6 month stigma towards schizophrenia assessment as the dependent variable, and treatment group as the independent variable. The Stigma Towards Schizophrenia with family-report is used at both timepoints.
Time Frame
baseline (pre-treatment). six months post-baseline.
Title
Patient-report for schizophrenia medication compliance, at 6 months post-baseline
Description
Analysis of Variance on medication compliance as reported by the patient
Time Frame
6 months post-baseline
Other Pre-specified Outcome Measures:
Title
Patient-report satisfaction with hospital services, at 6 months post-baseline
Description
Patient-report satisfaction with services provided by the hospital.
Time Frame
6 months post-baseline
Title
Family-report satisfaction with hospital services, at 6 months post-baseline
Description
Family-report satisfaction with services provided by the hospital.
Time Frame
6 months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizophrenia, based on ICD-10
Receive in-patient treatment at hospital
Length of schizophrenia less than 3 years.
Treated 3 or less times for schizophrenia.
Exclusion Criteria:
Mental retardation, or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled.
Suicidal ideation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngoc Tran, MD
Organizational Affiliation
Danang Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danang Psychiatric Hospital
City
Danang
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Psychoeducation for Vietnamese Families With a Patient With Schizophrenia
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