Efficacy of functional remediation in bipolar disorder: a multicenter randomized controlled study.

OBJECTIVE The authors sought to assess the efficacy of functional remediation, a novel intervention program, on functional improvement in a sample of euthymic patients with bipolar disorder. METHOD In a multicenter, randomized, rater-blind clinical trial involving 239 outpatients with DSM-IV bipolar disorder, functional remediation (N=77) was compared with psychoeducation (N=82) and treatment as usual (N=80) over 21 weeks. Pharmacological treatment was kept stable in all three groups. The primary outcome measure was improvement in global psychosocial functioning, measured blindly as the mean change in score on the Functioning Assessment Short Test from baseline to endpoint. RESULTS At the end of the study, 183 patients completed the treatment phase. Repeated-measures analysis revealed significant functional improvement from baseline to endpoint over the 21 weeks of treatment (last observation carried forward), suggesting an interaction between treatment assignment and time. Tukey's post hoc tests revealed that functional remediation differed significantly from treatment as usual, but not from psychoeducation. CONCLUSIONS Functional remediation, a novel group intervention, showed efficacy in improving the functional outcome of a sample of euthymic bipolar patients as compared with treatment as usual.

Development of the insight scale for affective disorders (ISAD): modification from the scale to assess unawareness of mental disorder.

BACKGROUND: Research on insight in patients with mood disorders has grown in recent years. Several instruments to assess insight have been used, but most of them have been specifically designed for psychosis and may not appear relevant to mood disorders. The aim of the present study is to develop a short, multidimensional, reliable and valid scale to measure insight in patients with mood disorders, based on the Amador's Scale to Assess Unawareness of Mental Disorders (SUMD). METHOD: A Delphi method was used to facilitate expert participation and ensure face and content validity. The SUMD structure and items were used as a reference in the scale development. A new scale with 17 items was obtained. Internal consistency, test-retest and inter-rater reliability and validity were studied in a sample of 76 outpatients with a DSM-IV diagnosis of major depression or bipolar disorder (type I or II). RESULTS: Internal consistency of the general items was moderate, and high for the symptoms awareness subscale. Scores on ISAD correlated with other measures of insight and with some clinical measures, thus supporting its validity. LIMITATIONS: The majority of the sample came from community services. Future studies should use inpatients or patients with severe symptoms to broaden the range of responses. Moreover, the rating of insight and other measures by the same clinician might introduce a methodological bias. CONCLUSION: The ISAD, with a multidimensional approach, appears as a short, reliable and valid measure of insight in mood disorders. Expert consensus ensures its face and content validity.