title: Two-year study of relapse prevention by a new education program in schizophrenic patients treated with the same antipsychotic drug.
abstract: It is not clear whether patient's psycho-education enhances compliance to antipsychotic treatments and reduces the number of relapses. Here we investigated the impact of a new psycho-educational program (SOLEDUC) on the one- and two-years rate of relapse (primary outcome measure) and a number of clinical assessments (secondary outcome measures). This was a multicentric French clinical trial (51 centers) of Phase IV, open, controlled, randomized, consisting in two parallel groups: the Soleduc group (N=111) and the control group (N=109). All subjects received a variable dose over the 2-year period of the same antipsychotic drug (amisulpride). Soleduc consisted of a 7-session program (1h per session), presented three times (at baseline, 6-months and 12-months). Patients in the control group received a non-specific psychosocial training for an equivalent period of time. The models of Andersen-Gill (AG) and Prentice, Williams and Peterson (PWP) were used to analyze relapses. Patients in the Soleduc group attended 14.8+/-6.1 sessions (mean+/-SD), including 17 patients who never attended a session. Intent to treat analysis showed less patients relapsing in the Soleduc group as compared to the control group (21.6% versus 28.4% after 1 year and 84.4% versus 90.8% after 2years), but the differences were not statistically significant. Relapse risk was significantly reduced for patients who followed at least 7 modules (p=0.015 AG-test; p<0.001 PWP-test). In conclusion, no significant differences in relapse rates were found between patients attending the Soleduc program and the control group. Attendance of at least 7 out of 21 program sessions was required to see a modest, but significant two-year relapse prevention in schizophrenia. Other well designed studies are required to evaluate the medical impact of patient's education programs.
authors.affiliation: Saint Egreve Hospital, Grenoble, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Chabannes
authors.forename: Nadine
authors.initials: N
authors.lastname: Bazin
authors.forename: Denis
authors.initials: D
authors.lastname: Leguay
authors.forename: Philippe
authors.initials: P
authors.lastname: Nuss
authors.forename: Charles-Siegfried
authors.initials: CS
authors.lastname: Peretti
authors.forename: Patrick
authors.initials: P
authors.lastname: Tatu
authors.forename: Ahcene
authors.initials: A
authors.lastname: Hameg
authors.forename: Ricardo P
authors.initials: RP
authors.lastname: Garay
authors.forename: Maurice
authors.initials: M
authors.lastname: Ferreri
mesh_terms: D000328:Adult; D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D017327:Clinical Trials, Phase IV as Topic / Q000706:statistics & numerical data; D035061:Control Groups; D005260:Female; D006801:Humans; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D011379:Prognosis; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011613:Psychotherapy / Q000379:methods; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy* / Q000517:prevention & control*; D012565:Schizophrenic Psychology; D055502:Secondary Prevention; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D013469:Sulpiride; D000077582:Amisulpride