Mindfulness-based cognitive therapy versus psychoeducational intervention in bipolar outpatients with sub-threshold depressive symptoms: a randomized controlled trial.
Study Goal
The researchers aimed to compare the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) versus a brief structured group psychoeducation intervention in reducing subsyndromal depressive symptoms and improving cognitive performance in bipolar disorder patients.
Results Summary
The study hypothesized that MBCT would be more effective than psychoeducation in reducing depressive symptoms and improving cognitive performance, with an expected increase in BDNF levels post-intervention. Results were not explicitly stated in the abstract, but the trial design suggests a rigorous comparison.
Population
Patients with bipolar disorder and subclinical or mild depressive symptoms.
Effective Dosage
Not specified
Duration
8 weeks (post-intervention assessment), with a 4-month follow-up.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-Based Cognitive Therapy (MBCT) | decrease | unipolar depression | - | - | has been shown effective | #1 |
MBCT added to psychopharmacological treatment | decrease | subsyndromal depressive symptoms | patients with BD and subclinical or mild depressive symptoms | - | will be more effective in reducing | #2 |
MBCT added to psychopharmacological treatment | increase | cognitive performance | patients with BD and subclinical or mild depressive symptoms | - | will improve | #3 |
MBCT intervention | increase | BDNF levels | - | - | a significant increase will be found after | #4 |
BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02133170. Registered 04/30/2014.