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Completed

NCT Number: NCT02715349

Psychoeducation for Vietnamese Families With a Patient With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danang Psychiatric Hospital

Da Nang, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation

Behavioral

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 outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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 outcomes

  1. Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.

    Time frame: 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.

  2. Change from baseline (pre-treatment) to 6 months post-baseline in family-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.

    Time frame: 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.

  3. Patient-report for schizophrenia medication compliance, at 6 months post-baseline

    Time frame: 6 months post-baseline

    Analysis of Variance on medication compliance as reported by the patient

Other outcomes

  1. Patient-report satisfaction with hospital services, at 6 months post-baseline

    Time frame: 6 months post-baseline

    Patient-report satisfaction with services provided by the hospital.

  2. Family-report satisfaction with hospital services, at 6 months post-baseline

    Time frame: 6 months post-baseline

    Family-report satisfaction with services provided by the hospital.

Sponsors and collaborators

Lead sponsor

Danang Psychiatric Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2016
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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