Psychoeducation for Vietnamese Families With a Patient With Schizophrenia
16. mars 2016 oppdatert av: Danang Psychiatric Hospital
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
59
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Danang, Vietnam
- Danang Psychiatric Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 30 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
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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.
|
|
Ingen inngripen: Control
Family and patient do not receive psychoeducation, but still receive standard hospital services for schizophrenia.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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.
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baseline (pre-treatment). six months post-baseline.
|
|
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.
Tidsramme: 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.
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baseline (pre-treatment). six months post-baseline.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
Tidsramme: 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.
|
baseline (pre-treatment). six months post-baseline.
|
|
Change from baseline (pre-treatment) to 6 months post-baseline in family-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
Tidsramme: 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.
|
baseline (pre-treatment). six months post-baseline.
|
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Patient-report for schizophrenia medication compliance, at 6 months post-baseline
Tidsramme: 6 months post-baseline
|
Analysis of Variance on medication compliance as reported by the patient
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6 months post-baseline
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-report satisfaction with hospital services, at 6 months post-baseline
Tidsramme: 6 months post-baseline
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Patient-report satisfaction with services provided by the hospital.
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6 months post-baseline
|
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Family-report satisfaction with hospital services, at 6 months post-baseline
Tidsramme: 6 months post-baseline
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Family-report satisfaction with services provided by the hospital.
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6 months post-baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ngoc Tran, MD, Danang Psychiatric Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2014
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først innsendt
3. mars 2016
Først innsendt som oppfylte QC-kriteriene
16. mars 2016
Først lagt ut (Anslag)
22. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DPH20140818
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ubestemt
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