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Trial record 10 of 3314 for:    schizophrenia

Psychoeducation for Vietnamese Families With a Patient With Schizophrenia

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ClinicalTrials.gov Identifier: NCT02715349
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Psychoeducation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychoeducation for Vietnamese Families With a Patient With Schizophrenia
Study Start Date : September 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

No Intervention: Control
Family and patient do not receive psychoeducation, but still receive standard hospital services for schizophrenia.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715349


Locations
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Vietnam
Danang Psychiatric Hospital
Danang, Vietnam
Sponsors and Collaborators
Danang Psychiatric Hospital
Investigators
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Principal Investigator: Ngoc Tran, MD Danang Psychiatric Hospital

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Responsible Party: Danang Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT02715349     History of Changes
Other Study ID Numbers: DPH20140818
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Danang Psychiatric Hospital:
schizophrenia
psychoeducation
Vietnam
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders