Abstract
BackgroundThe presence of depressive subsyndromal symptoms (SS) in bipolar disorder (BD) increases the risk of affective relapse and worsens social, cognitive functioning, and quality of life. Nonetheless, there are limited data on how to optimize the treatment of subthreshold depressive symptoms in BD. Mindfulness-Based Cognitive Therapy (MBCT) is a psychotherapeutic intervention that has been shown effective in unipolar depression. The assessment of its clinical effectiveness and its impact on biomarkers in bipolar disorder patients with subsyndromal depressive symptoms and psychopharmacological treatment is needed.Methods/designA randomized, multicenter, prospective, versus active comparator, evaluator-blinded clinical trial is proposed. Patients with BD and subclinical or mild depressive symptoms will be randomly allocated to: 1) MBCT added to psychopharmacological treatment; 2) a brief structured group psychoeducational intervention added to psychopharmacological treatment; 3) standard clinical management, including psychopharmacological treatment. Assessments will be conducted at screening, baseline, post-intervention (8 weeks) and 4 month follow-up post-intervention. The aim is to compare MBCT intervention versus a brief structured group psychoeducation. Our hypothesis is that MBCT will be more effective in reducing the subsyndromal depressive symptoms and will improve cognitive performance to a higher degree than the psychoeducational treatment. It is also hypothesized that a significant increase of BDNF levels will be found after the MBCT intervention.DiscussionThis is the first randomized controlled trial to evaluate the effects of MBCT compared to an active control group on depressive subthreshold depressive symptoms in patients with bipolar disorder.Trial registrationClinicalTrials.gov: NCT02133170. Registered 04/30/2014.
Highlights
The presence of depressive subsyndromal symptoms (SS) in bipolar disorder (BD) increases the risk of affective relapse and worsens social, cognitive functioning, and quality of life
This is the first randomized controlled trial to evaluate the effects of Mindfulness-Based Cognitive Therapy (MBCT) compared to an active control group on depressive subthreshold depressive symptoms in patients with bipolar disorder
Our objective is to evaluate the efficacy of the MBCT added to standard drug treatment -following the recommendations of the Spanish Guideline for the Treatment of BD [11])- versus structured group psychoeducation versus standard clinical management
Summary
The presence of depressive subsyndromal symptoms (SS) in bipolar disorder (BD) increases the risk of affective relapse and worsens social, cognitive functioning, and quality of life. The assessment of its clinical effectiveness and its impact on biomarkers in bipolar disorder patients with subsyndromal depressive symptoms and psychopharmacological treatment is needed. Concomitant psychosocial interventions are recommended, such cognitive behavioral therapy (CBT), interpersonal and social rhythm therapy (IPSRT) and structured psychoeducation, especially for stabilization between episodes and relapse prevention [11]. A 21-session individual CBT was shown as effective -but much less cost-effectiveas a brief psychoeducational group intervention, with overall decrease in disease burden, effectiveness in preventing episodes and time to relapse [12]. A combined treatment (pharmacological plus psychoeducational and cognitive-behavioral therapy) has shown to decrease depressive symptoms, even in refractory BD, and the number of hospitalizations [13]. Despite psychoeducational interventions appear to be most promising, the development of effective psychosocial therapies is still needed
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