Külz Anne Katrin, Landmann Sarah, Cludius Barbara, Hottenrott Birgit, Rose Nina, Heidenreich Thomas, Hertenstein Elisabeth, Voderholzer Ulrich, Moritz Steffen
Clinic of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMC Psychiatry. 2014 Nov 18;14:314. doi: 10.1186/s12888-014-0314-8.
Obsessive-compulsive disorder (OCD) is a very disabling condition with a chronic course, if left untreated. Though cognitive behavioral treatment (CBT) with or without selective serotonin reuptake inhibitors (SSRI) is the method of choice, up to one third of individuals with obsessive-compulsive disorder (OCD) do not respond to treatment in terms of at least 35% improvement of symptoms. Mindfulness based cognitive therapy (MBCT) is an 8-week group program that could help OCD patients with no or only partial response to CBT to reduce OC symptoms and develop a helpful attitude towards obsessions and compulsive urges.
METHODS/DESIGN: This study is a prospective, bicentric, assessor-blinded, randomized, actively-controlled clinical trial. 128 patients with primary diagnosis of OCD according to DSM-IV and no or only partial response to CBT will be recruited from in- and outpatient services as well as online forums and the media. Patients will be randomized to either an MBCT intervention group or to a psycho-educative coaching group (OCD-EP) as an active control condition. All participants will undergo eight weekly sessions with a length of 120 minutes each of a structured group program. We hypothesize that MBCT will be superior to OCD-EP in reducing obsessive-compulsive symptoms as measured by the Yale-Brown-Obsessive-Compulsive Scale (Y-BOCS) following the intervention and at 6- and 12-months-follow-up. Secondary outcome measures include depressive symptoms, quality of life, metacognitive beliefs, self-compassion, mindful awareness and approach-avoidance tendencies as measured by an approach avoidance task.
The results of this study will elucidate the benefits of MBCT for OCD patients who did not sufficiently benefit from CBT. To our knowledge, this is the first randomized controlled study assessing the effects of MBCT on symptom severity and associated parameters in OCD.
German Clinical Trials Register DRKS00004525 . Registered 19 March 2013.
强迫症(OCD)是一种慢性致残性疾病,若不治疗,病情会持续发展。虽然认知行为疗法(CBT)无论是否联合选择性5-羟色胺再摄取抑制剂(SSRI)都是首选治疗方法,但高达三分之一的强迫症患者在症状改善至少35%方面对治疗无反应。基于正念的认知疗法(MBCT)是一个为期8周的团体项目,可帮助对CBT无反应或仅有部分反应的强迫症患者减轻强迫症状,并培养对强迫观念和强迫冲动的有益态度。
方法/设计:本研究是一项前瞻性、双中心、评估者盲法、随机、积极对照的临床试验。将从门诊和住院服务以及在线论坛和媒体中招募128例根据《精神疾病诊断与统计手册》第四版(DSM-IV)初步诊断为强迫症且对CBT无反应或仅有部分反应的患者。患者将被随机分为MBCT干预组或心理教育指导组(OCD-EP)作为积极对照。所有参与者将参加为期八周、每周一次、每次120分钟的结构化团体项目。我们假设,干预后以及6个月和12个月随访时,通过耶鲁-布朗强迫症量表(Y-BOCS)测量,MBCT在减轻强迫症状方面将优于OCD-EP。次要结局指标包括通过趋近-回避任务测量的抑郁症状、生活质量、元认知信念、自我同情、正念意识和趋近-回避倾向。
本研究结果将阐明MBCT对未从CBT中充分获益的强迫症患者的益处。据我们所知,这是第一项评估MBCT对强迫症症状严重程度及相关参数影响的随机对照研究。
德国临床试验注册中心DRKS00004525。2013年3月19日注册。