Context
Antipsychotic drugs are limited in their ability to improve the overall outcome of schizophrenia. Adding psychosocial treatment may produce greater improvement in functional outcome than does medication treatment alone.
Objective
To evaluate the effectiveness of antipsychotic medication alone versus combined with psychosocial intervention on outcomes of early stage schizophrenia.
Design, Setting, and Participants
Randomized controlled trial of a clinical sample of 1268 patients with early stage schizophrenia, conducted at 10 clinical sites in China from 2005–2007.
Intervention
Patients were randomly assigned to antipsychotic medication treatment only or antipsychotic medication plus 12 months of psychosocial intervention, consisting of psycho-education, family intervention, skills training and cognitive-behavioral therapy, administered over 48 group sessions.
Main Outcome Measures
The rate of treatment discontinuation or change due to any cause, relapse or remission, and assessments of insight, treatment adherence, quality of life and social functioning.
Results
The rates of treatment discontinuation or change due to any cause were 32.8% in the combined treatment group and 46.8% in the medication alone group. Comparisons with medication treatment alone showed lower risk for any cause discontinuation with combined treatment (hazard ratios [HR], 0.62; 95% confidence interval [CI], 0.52–0.74; p<0.001); and lower risk for relapse with combined treatment (HR, 0.57; 95%CI, 0.44–0.74; p<0.001). The combined treatment group exhibited greater improvement in insight (p<0.001), social functioning (p=0.002), activities of daily living (p<0.001), and in 4 domains of quality of life as measured by Medical Outcome Study Short-Form 36-item questionnaire (all p-values<0.02). Furthermore, a significantly higher proportion of patients receiving combined treatment obtained employment or accessed education (p=0.001).
Conclusions
Compared to those receiving medications only, early stage schizophrenia patients receiving medications and psychosocial intervention had a lower rate of treatment discontinuation or change, lower risk of relapse, and improved insight, quality of life and social functioning.