Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial
Relapse Prevention in First Episode of Schizophrenia and Related Psychotic Disorders: a 5 Year Randomized Controlled Trial
Objective: to evaluate the effectiveness of specialised and sustained intervention with or without parent groups during the initial phase of schizophrenia or related disorders on relapse prevention
Methods: A three conditions randomized trial with a duration of five years
Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic episode of schizophrenia or related disorder
Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent groups (ST+P) and Treatment As Usual (TAU).
Outcome-measures: cumulative relapse rates and time to first relapse after first remission. Secondary outcome measure: social functioning.
Statistical analysis: cumulative relapse rates using life-table methods. The effect of the three interventions on time to first relapse after remission will be compared using Cox regression analysing intention to treat (ITT) grouping.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Evidence for optimal duration and necessary ingredients of early and sustained specialized treatment from first episode psychosis till the end of the initial phase schizophrenia is still insufficient. Randomized trials with a treatment duration of six months to two years with favorable symptomatic and psychosocial results disappeared at five year follow-up. Other studies suggest that specialized treatment should last 5 years in order to be able to prevent instead of only delaying clinical and psychosocial deteriorating.
In this study we examine both the symptomatic (relapse) and psychosocial outcome of a three armed five year randomized trial in the initial phase of schizophrenia.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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N Holland
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Amsterdam, N Holland, Nederland, 1105BC
- Academic Medical Center University of Amsterdam
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients were eligible for the study if they: 1) met DSM-IV-Revised criteria for schizophrenia or related disorders, 2) were suffering from a first psychotic episode and 3) were living in contact with parent(s) or other relatives.
Exclusion Criteria:
- Patients with drug-related psychoses were not included.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Continuity of specialized care
Continuity of specialized inpatient and outpatient care (relapse prevention)
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Continuity of care in treatment and professional caregiver was given during 5 year.
Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).
Andere namen:
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Experimenteel: Continuity of specialized care and parent groups
Continuity of specialized care combined with Parent groups
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Continuity of care in treatment and professional caregiver was given during 5 year.
Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).
Andere namen:
Approximately fifty parent group therapy sessions will be held in a flexible way over a 60 month period.
Each parent group was run by two experienced family therapists.
Andere namen:
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Actieve vergelijker: Treatment as usual
Discontinuity of care, relapse prevention as usual
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Standard Treatment as usual (TU) was provided during 5 years by local mental health care professionals situated nearby the domicile of patients.
TU had comparable treatment targets as ST but was not provided by treatment staff specialized in early intervention in schizophrenia or related disorders.
However, TU was (like ST) sustained and dedicated to prevent psychotic relapse and improve social functioning.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Psychotic relapse
Tijdsspanne: at year 1, year 3 and year 5
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Participants will be followed for the duration of the 5 year outpatient treatment of the trial. During the trial the timing and number of psychotic relapses of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial. Trained interviewers not involved in clinical treatment of patients will elicit with the LCS detailed information of symptoms, signs and treatment from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in symptomatology since the last interview. All details will be fitted in a schedule with 6 months intervals. |
at year 1, year 3 and year 5
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Social functioning
Tijdsspanne: at year 1, year 3 and year 5
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During the duration of the 5 year outpatient treatment of the trial social functioning of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial. Detailed information of social functioning in work, study, school and relations will be elicited from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in functioning since the last interview.All details will be fitted in a schedule with 6 months. |
at year 1, year 3 and year 5
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Don Linszen, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publicaties en nuttige links
Algemene publicaties
- Linszen D, Dingemans P, Lenior M. Early intervention and a five year follow up in young adults with a short duration of untreated psychosis: ethical implications. Schizophr Res. 2001 Aug 1;51(1):55-61. doi: 10.1016/s0920-9964(01)00239-0.
- Linszen D, Lenior M, De Haan L, Dingemans P, Gersons B. Early intervention, untreated psychosis and the course of early schizophrenia. Br J Psychiatry Suppl. 1998;172(33):84-9.
- Linszen D, Dingemans P, Van der Does JW, Nugter A, Scholte P, Lenior R, Goldstein MJ. Treatment, expressed emotion and relapse in recent onset schizophrenic disorders. Psychol Med. 1996 Mar;26(2):333-42. doi: 10.1017/s0033291700034723.
- Lenior ME, Dingemans PM, Linszen DH, de Haan L, Schene AH. Social functioning and the course of early-onset schizophrenia: five-year follow-up of a psychosocial intervention. Br J Psychiatry. 2001 Jul;179:53-8. doi: 10.1192/bjp.179.1.53.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Grant 28-1241-2
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