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.

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).

After finishing the treatment, the repeated-measures analyses revealed a significant group × 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(1,57) = 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(1,57) = 19.1; p < 0.001) and leisure time (Pillai's trace = 0.11; F(1,57) = 7.15; p = 0.01). Regarding the secondary outcomes, a significant group × time interaction in Hamilton Depression Rating Scale changes was detected (Pillai's trace = 0.08; F(1,62) = 5.6; p = 0.02).

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.

双相情感障碍（BD）是治疗上最复杂的精神疾病之一。需要开发一种可行的综合心理方法来补充药物治疗，以改善其临床管理。本随机对照试验 (RCT) 的主要目的是测试一种名为综合方法的新型辅助治疗对 BD 患者的疗效，包括：心理教育、正念训练和功能性补救。

这是一项平行双臂、评估者盲法随机对照试验，采用综合方法加常规治疗 (TAU) 与单独 TAU对比。参与者是在巴塞罗那医院诊所招募的，并随机分配到两种情况之一。他们在基线和完成干预后进行评估。主要结果变量包括通过功能评估短期测试（FAST）评估的心理社会功能的变化。

完成治疗后，重复测量分析显示，与 TAU 组 ( n = 37) 相比，接受综合方法 ( n = 28) 的患者存在显着的组 × 时间交互作用（Pillai 迹线 = 0.10； F （ 1,57) = 6.9; p = 0.01)，改善功能结果。 FAST 的六个领域中的两个领域也发现了显着影响，包括认知领域（Pillai 迹 = 0.25； F (1,57) = 19.1； p < 0.001）和休闲时间（Pillai 迹 = 0.11； F） (1,57) = 7.15； p = 0.01)。关于次要结果，检测到汉密尔顿抑郁量表变化中存在显着的组×时间交互作用（Pillai 迹 = 0.08； F (1,62) = 5.6； p = 0.02）。

这项初步研究表明，综合方法是一种有前途的、具有成本效益的疗法，可以改善双相情感障碍患者的社会心理功能和残余抑郁症状。