Efficacy of an integrative approach for bipolar disorder: preliminary results from a randomized controlled trial

Background Bipolar disorder (BD) represents one of the most therapeutically complex psychiatric disorders. The development of a feasible comprehensive psychological approach to complement pharmacotherapy to improve its clinical management is required. The main objective of the present randomized controlled trial (RCT) was to test the efficacy of a novel adjunctive treatment entitled integrative approach in patients with BD, including: psychoeducation, mindfulness training, and functional remediation. Methods This is a parallel two-armed, rater-blind RCT of an integrative approach plus treatment as usual (TAU), v. TAU alone. Participants were recruited at the Hospital Clinic of Barcelona and randomized to one of the two conditions. They were assessed at baseline and after finishing the intervention. The main outcome variable included changes in psychosocial functioning assessed through the Functioning Assessment Short Test (FAST). Results After finishing the treatment, the repeated-measures analyses revealed a significant group x time interaction in favor of the patients who received the integrative approach (n = 28) compared to the TAU group (n = 37) (Pillai's trace = 0.10; F-(1,F-57) = 6.9; p = 0.01), improving the functional outcome. Significant effects were also found in two out of the six domains of the FAST, including the cognitive domain (Pillai's trace = 0.25; F-(1,F-57) = 19.1; p < 0.001) and leisure time (Pillai's trace = 0.11; F-(1,F-57) = 7.15; p = 0.01). Regarding the secondary outcomes, a significant group x time interaction in Hamilton Depression Rating Scale changes was detected (Pillai's trace = 0.08; F-(1,F-62) = 5.6; p = 0.02). Conclusion This preliminary study suggests that the integrative approach represents a promising cost-effective therapy to improve psychosocial functioning and residual depressive symptoms in patients suffering from BD.