BACKGROUND: The aim of this research was to evaluate the short-term and long-term efficacy of a combined treatment (pharmacological + psychoeducational and cognitive-behavioral therapy) as compared with a standard pharmacological treatment in patients with refractory bipolar disorder. METHOD: 40 patients were randomly assigned to one of the following: Experimental group under combined treatment, and Control group under pharmacological treatment. We used an analysis of variance (ANOVA), including one or two factors, with repeated measures at different evaluation times: baseline, post-treatment, 6-month follow-up and 12-month follow-up. RESULTS: We found significant between-group differences at all evaluation times after the treatment. The experimental group showed less hospitalizations than the control group in the 12-month evaluation (p=0.007) as well as lower rates of depression and anxiety in the 6-month valuation (p=0.015; p=0.027) and the 12-month evaluation (p=0.001; p<0.001). Significant differences in relation to mania and inadaptation emerged in the post-treatment evaluation (p=0.004; p<0.001) and were sustained throughout the study (p=0.002, p<0.001; p<0.001, p<0.001). Analysis of within-group differences in the Experimental group showed reduction of mania (p<0.001), depression (p=0.001), anxiety (p=0.003) and inadaptation (p<0.001) throughout the study; while in the Control group, it showed increased numbers of hospitalizations (p=0.016), as well as higher rates of mania (p=0.030), anxiety (p<0.001) and inadaptation (p=0.003). CONCLUSIONS: Our results suggest that a combined treatment is effective in patients with refractory bipolar disorder. Suggestions for future research are commented on. Copyright 2010 Elsevier B.V. All rights reserved.
RCT Entities:
BACKGROUND: The aim of this research was to evaluate the short-term and long-term efficacy of a combined treatment (pharmacological + psychoeducational and cognitive-behavioral therapy) as compared with a standard pharmacological treatment in patients with refractory bipolar disorder. METHOD: 40 patients were randomly assigned to one of the following: Experimental group under combined treatment, and Control group under pharmacological treatment. We used an analysis of variance (ANOVA), including one or two factors, with repeated measures at different evaluation times: baseline, post-treatment, 6-month follow-up and 12-month follow-up. RESULTS: We found significant between-group differences at all evaluation times after the treatment. The experimental group showed less hospitalizations than the control group in the 12-month evaluation (p=0.007) as well as lower rates of depression and anxiety in the 6-month valuation (p=0.015; p=0.027) and the 12-month evaluation (p=0.001; p<0.001). Significant differences in relation to mania and inadaptation emerged in the post-treatment evaluation (p=0.004; p<0.001) and were sustained throughout the study (p=0.002, p<0.001; p<0.001, p<0.001). Analysis of within-group differences in the Experimental group showed reduction of mania (p<0.001), depression (p=0.001), anxiety (p=0.003) and inadaptation (p<0.001) throughout the study; while in the Control group, it showed increased numbers of hospitalizations (p=0.016), as well as higher rates of mania (p=0.030), anxiety (p<0.001) and inadaptation (p=0.003). CONCLUSIONS: Our results suggest that a combined treatment is effective in patients with refractory bipolar disorder. Suggestions for future research are commented on. Copyright 2010 Elsevier B.V. All rights reserved.
Authors: Konstantinos N Fountoulakis; Lakshmi N Yatham; Heinz Grunze; Eduard Vieta; Allan H Young; Pierre Blier; Mauricio Tohen; Siegfried Kasper; Hans Jurgen Moeller Journal: Int J Neuropsychopharmacol Date: 2020-04-23 Impact factor: 5.176