- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00940394
Effectiveness of Family Group Interventions for People With Schizophrenia (MSG)
19. august 2014 opdateret af: Chien Wai-Tong, The Hong Kong Polytechnic University
Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia
The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Family interventions in schizophrenia have shown positive effects on patients but little attention has been paid to their effects on family members, particularly those in non-Western countries.
This multi-site randomized controlled trial evaluated the effectiveness of a bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of schizophrenia sufferers over 36 months, compared with a family psychoeducation group program and standard psychiatric care.
It was conducted with 114 families of outpatients with schizophrenia in Hong Kong of whom 38 were assigned randomly to a mutual support group, a psychoeducation group, or standard care.
Families' psychosocial health status and patients' symptom severity and length of re-hospitalizations at recruitment, one-month, 18-month, and 36-month post-intervention were compared between groups.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
128
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
NT
-
Sha Tin, NT, Hong Kong
- Li Ka Shing Specialty OPD
-
Taipo, NT, Hong Kong
- AHNH Psychiatric OPD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- family caregivers lived with and cared for one family member diagnosed with schizophrenia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; American Psychiatric Association, 1994)
- family caregivers were at least 18 years of age and could understand and read the Chinese (Mandarin) language; and
- family caregivers were free from any mental illness themselves.
Exclusion Criteria:
- the patients with schizophrenia suffered no co-morbidity due to other mental illness during recruitment to the study
- family caregivers cared for more than one family member with mental or chronic physical illness; and/or
- family caregivers had been the primary carers for less than three months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: standard care
Families receive routine community and family mental health care services
|
Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia
Andre navne:
|
Eksperimentel: mutual support group
bi-weekly, 12-session, family-led mutual support group
|
bi-weekly, 12-session, family-led mutual support group
Andre navne:
|
Aktiv komparator: psychoeducation group
bi-weekly, 12-session, family psychoeducation group program
|
bi-weekly, 12-session, family psychoeducation group
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
length of re-hospitalizations
Tidsramme: at recruitment, six-month, 18-month and 36-month post-intervention
|
at recruitment, six-month, 18-month and 36-month post-intervention
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
families' perceived social support
Tidsramme: at recruitment, six-month, 18-month and 36-month post-intervention
|
at recruitment, six-month, 18-month and 36-month post-intervention
|
patients' symptom severity
Tidsramme: at recruitment, six-month, 18-month and 36-month post-intervention
|
at recruitment, six-month, 18-month and 36-month post-intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Chien Wai-Tong, PhD, The Hong Kong Polytechnic University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Chien WT, Thompson DR, Norman I. Evaluation of a peer-led mutual support group for Chinese families of people with schizophrenia. Am J Community Psychol. 2008 Sep;42(1-2):122-34. doi: 10.1007/s10464-008-9178-8.
- Chien WT, Thompson DR. An RCT with three-year follow-up of peer support groups for Chinese families of persons with schizophrenia. Psychiatr Serv. 2013 Oct;64(10):997-1005. doi: 10.1176/appi.ps.201200243.
- Chien WT, Chan SW. The effectiveness of mutual support group intervention for Chinese families of people with schizophrenia: a randomised controlled trial with 24-month follow-up. Int J Nurs Stud. 2013 Oct;50(10):1326-40. doi: 10.1016/j.ijnurstu.2013.01.004. Epub 2013 Feb 19.
- Chien WT, Bressington D, Chan SWC. A Randomized Controlled Trial on Mutual Support Group Intervention for Families of People With Recent-Onset Psychosis: A Four-Year Follow-Up. Front Psychiatry. 2018 Dec 18;9:710. doi: 10.3389/fpsyt.2018.00710. eCollection 2018.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2007
Primær færdiggørelse (Faktiske)
1. september 2011
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
15. juli 2009
Først indsendt, der opfyldte QC-kriterier
15. juli 2009
Først opslået (Skøn)
16. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 216020
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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