Abstract
BACKGROUND: Psycho-educational interventions for people diagnosed with schizophrenia (PDwS) and their primary caregivers appear promising, however, the majority of trials have significant methodological shortcomings. There is little known about the effects of these interventions delivered in a booklet format in resource-poor countries. METHODS: A randomized controlled trial was conducted from September, 2012 to July, 2013 with 121 dyads of PDwS and their primary caregivers. Participants aged 18 years or older with DSM-IV schizophrenia or schizoaffective disorder, and their primary caregivers, from four outpatient mental health clinics in Jordan, were randomly assigned to receive 12 weeks of a booklet form of psycho-education, with follow-up phone calls, and treatment as usual [TAU] (intervention, n = 58), or TAU (control, n = 63). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in knowledge of schizophrenia. Secondary outcomes for PDwS were psychiatric symptoms and relapse rate, with hospitalization or medication (number of episodes of increasing antipsychotic dosage), and for primary caregivers were burden of care and quality of life. RESULTS: PDwS in the intervention group experienced greater improvement in knowledge scores (4.9 vs -0.5; p <0.001) at post-treatment and (6.5 vs -0.7; p <0.001) at three month-follow-up, greater reduction in symptom severity (-26.1 vs 2.5; p <0.001: -36.2 vs -4.9; p <0.001, at follow-up times respectively. Relapse rate with hospitalization was reduced significantly at both follow-up times in the intervention group (p <0.001), and relapse with medication increased in the intervention group at both follow-up times (p <0.001). Similarly there was a significant improvement in the primary caregivers knowledge score at post-treatment (6.3 vs -0.4; P < 0.001) and three month-follow-up (7.3 vs -0.7; p <0.001). Primary caregivers burden of care was significantly reduced in the intervention group (-6.4 vs 1.5; p <0.001; -9.4 vs 0.8; p <0.001), and their quality of life improved (9.2 vs -1.6; p = 0.01; 17.1 vs -5.3; p <0.001) at post-treatment and three month-follow-up. CONCLUSIONS: Psycho-education and TAU was more effective than TAU alone at improving participants' knowledge and psychological outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78084871 .