基于正念的认知疗法与心理教育干预对伴有阈下抑郁症状的双相情感障碍门诊患者的疗效比较：一项随机对照试验
Mindfulness-based cognitive therapy versus psychoeducational intervention in bipolar outpatients with sub-threshold depressive symptoms: a randomized controlled trial.
作者信息
Lahera Guillermo, Bayón Carmen, Fe Bravo-Ortiz Maria, Rodríguez-Vega Beatriz, Barbeito Sara, Sáenz Margarita, Avedillo Caridad, Villanueva Rosa, Ugarte Amaia, González-Pinto Ana, de Dios Consuelo
机构信息
University Hospital La Paz, IDIPAZ, Madrid, Spain.
出版信息
BMC Psychiatry. 2014 Aug 15;14:215. doi: 10.1186/s12888-014-0215-x.
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.
背景
双相情感障碍（BD）中存在抑郁亚综合征症状（SS）会增加情感复发风险，并使社会、认知功能及生活质量恶化。然而，关于如何优化双相情感障碍阈下抑郁症状的治疗的数据有限。基于正念的认知疗法（MBCT）是一种心理治疗干预措施，已被证明对单相抑郁有效。需要评估其在双相情感障碍伴亚综合征抑郁症状及药物治疗患者中的临床疗效及其对生物标志物的影响。
方法/设计：提出一项随机、多中心、前瞻性、与活性对照比较、评估者盲法的临床试验。双相情感障碍伴亚临床或轻度抑郁症状的患者将被随机分配至：1）在药物治疗基础上加用MBCT；2）在药物治疗基础上加用简短的结构化团体心理教育干预；3）标准临床管理，包括药物治疗。将在筛查、基线、干预后（8周）及干预后4个月随访时进行评估。目的是比较MBCT干预与简短的结构化团体心理教育。我们的假设是，MBCT在减轻亚综合征抑郁症状方面将更有效，并且在改善认知表现方面将比心理教育治疗达到更高程度。还假设在MBCT干预后将发现脑源性神经营养因子（BDNF）水平显著升高。
讨论
这是第一项评估MBCT与活性对照组相比对双相情感障碍患者阈下抑郁症状影响的随机对照试验。
试验注册
ClinicalTrials.gov：NCT02133170。于2014年4月30日注册。
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