Mindfulness-based cognitive therapy in obsessive-compulsive disorder: protocol of a randomized controlled trial

Abstract

Background: 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.

Discussion: 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.

Trial registration: German Clinical Trials Register DRKS00004525 . Registered 19 March 2013.

Figure 1

Study design and measurement time points (CONSORT chart). AQ-10 = autism spectrum quotient short version; AAT = approach avoidance task; BDI = Beck Depression Inventory II; BSI = Brief Symptom Inventory; KIMS = Kentucky Inventory of Mindfulness Skills; MBCT = Mindfulness Based Cognitive Therapy; MCQ-30 = Metacognitions Questionnaire with 30 Items; WST = Test of Word Power; OBQ = Obsessive Beliefs Questionnaire; OCD-EP = Obsessive Compulsive Disorder Education Program; OCI-R = Obsessive-Compulsive Inventory; SBQ-R = Suicidal Behaviors Questionnaire-Revised; M.I.N.I Mini-International Neuropsychiatric Interview; INEP = Inventory of negative effects of psychotherapy; WHOQOL-BREF = World Health Organization Quality of Life-BREF; Y-BOCS = Yale Brown Obsessive Compulsive Scale.