Psychoeducation for Vietnamese Families With a Patient With Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Psychoeducation

• Registration Number: NCT02715349
• Lead Sponsor: Danang Psychiatric Hospital

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-16
• Last Update Submitted: 2016-03-16
• Study First Posted: 2016-03-22
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation	Psychoeducation	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 Measures

Name	Time	Method
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.	baseline (pre-treatment). six months post-baseline.	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.	baseline (pre-treatment). six months post-baseline.	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

Name	Time	Method
Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.	baseline (pre-treatment). six months post-baseline.	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.	baseline (pre-treatment). six months post-baseline.	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	6 months post-baseline	Analysis of Variance on medication compliance as reported by the patient

Trial Locations

Locations (1)

Danang Psychiatric Hospital; 🇻🇳 Danang, Vietnam