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Mindfulness-based cognitive therapy versus psychoeducational intervention in bipolar outpatients with sub-threshold depressive symptoms: a randomized controlled trial.

Guillermo Lahera, Carmen Bayón, Maria-Fe Bravo-Ortiz, Beatriz Rodriguez-Vega, Sara Barbeito, Margarita Sáenz, Caridad Avedillo, Rosa Villanueva, Amaia Ugarte, Ana González-Pinto, Consuelo de Dios

BMC Psychiatry August 15, 2014 DOI: 10.1186/s12888-014-0215-x (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized, multicenter, prospective, active-comparator, evaluator-blinded clinical trial protocol Peer reviewed
Population Patients with bipolar disorder and subclinical or mild depressive symptoms receiving psychopharmacological treatment
Interventions Mindfulness-Based Cognitive Therapy (MBCT) brief structured group psychoeducational intervention standard clinical management psychopharmacological treatment
Duration 8-week intervention, with assessments at post-intervention (8 weeks) and 4-month follow-up post-intervention
Topics Meditation
Registration NCT02133170
Key findings The authors propose a randomized trial to test whether MBCT, added to medication, reduces subsyndromal depressive symptoms and improves cognitive performance more than brief structured group psychoeducation in bipolar disorder. They also hypothesize that MBCT will produce a significant increase in BDNF levels. No results are reported; the text is a trial protocol.

Abstract

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. 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. A 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. This 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. ClinicalTrials.gov: NCT02133170. Registered 04/30/2014.

Comparable studies

Other randomized controlled trials on meditation, most cited first.

Study Year Design Participants
Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment 2003 Randomized controlled trial n = 41
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults 2008 Randomized controlled trial n = 139
Short-term meditation training improves attention and self-regulation Undergraduate Chinese students 2007 Randomized controlled trial n = 40
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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