The Study of Mindfulness Based Cognitive Therapy and Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The primary objective of the study is to evaluate the clinical curative effect of MBCT to
      reduce obsessive and compulsive symptoms. Moreover, the investigators will also explore a
      MBCT manual for Chinese patients with OCD, which can be widely applied to the clinical
      practice.

      There are two parts of the study. The first part is a qualitative research with two pilot
      MBCT groups. The second part of this study is a single-blind randomized controlled trial with
      three study arms: one - third of participants receive group mindfulness-based cognitive
      therapy led by trained MBCT psychotherapists or psychiatrists in addition to medication, one
      - third of participants receive group psycho-education program and one - third of
      participants receive drug therapy as usual. All participants have 10 sessions intervention
      and assessments.
    

Detailed description: 
      The qualitative research will use grounded theory path to interview therapists and patients
      for 60 minutes in the baseline, after 5 weeks treatments and after the 10 weeks treatments.
      The subjective experience of the therapists and patients in two pilot MBCT groups will be
      described and explained. And the entire process of treatments will be participatory observed.

      In the second part of the study, all patients will take blood test and functional magnetic
      resonance imaging (fMRI) scan in the baseline and after 10 weeks, to gather data in genetics
      and imaging features, which can help the study to discover biological indicators of the
      curative effect. And after the patients and their custodians signed the consent form, all of
      participants will be blindly assigned to three groups by a predetermined random table which
      is generated by Microsoft Excel 2010 for ensuring randomly fair distribution across
      conditions. The investigators will not decode these numbers until the intervention group is
      assigned.

      As the research tools, a range of self-rating scales, other-rating scales and behavioral and
      physiological measures will be mainly applied to assess clinical symptoms of participants at
      baseline (week 0), mid-treatment (week 4), at the end of acute treatment (week 10), and
      during the maintenance phase (week 14, 22 and 34).

      After 10 sessions, all the participants including the non-responders and the responders (ie,
      decrease in Yale-Brown Obsessive Compulsive Scale [YBOCS] scores ≥ 25%) will enter the
      maintenance phase for 6 months. The participants in MBCT group will continue MBCT treatments
      at home. The participants in drug therapy group will continue on their treatment program
      without changing the type and dosage of medication they have been using. By comparing
      clinical symptoms, such as obsessive and compulsive symptoms, anxiety, depression, quality of
      life and other clinical symptoms and behavior, the study will describe the short-term and
      long-term effects of MBCT in patients with DSM-IV obsessive-compulsive disorder (OCD).
    

Intervention name(s): Mindfulness-based Cognitive Therapy; Psycho-education Program; sertraline, fluvoxamine
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): The intervention will be carried out according to the handbook of the Dr. Didonna. There is a Session Agenda from Dr. Didonna for the use of the Instructor and session handouts for the participants. Some records of mindfulness practices will be given to participants for facilitating practice between sessions. Before each session, the instructor needs to review the session agenda and prepare copies of handouts for participants.
MBCT instructors were experienced psychotherapists and psychiatrists with several years' expertise in OCD treatment. They had been trained by one of the founders of MBCT, Mark Williams and the founder of MBCT for OCD, Fabrizio Didonna. Supervision will be provided by Dr.Didonna.; As a widely used placebo control condition, the Psycho-Education Program can play an active role through the psychological suggestion and forward thinking mostly. It is designed to be similar with MBCT in level of structure, setting and other non-specific effects of psychological intervention. All instructors will be qualified graduate students who major in clinical psychology with training in cognitive behavioral therapy and psychodynamic therapy.; The participants can be adjustable once a week dose and the maximum dose does not exceed the maximum amount of instructions. And benzodiazepine drugs also can be used by the OCD patients with sleep disorders, but not be used continuously for more than two weeks. Besides this, other psychotropic drugs are not allowed to use. The use of drugs in this study are commonly used drugs with good safety, and its common adverse reactions include dry mouth, constipation, nausea, indigestion, dizziness, fatigue, sweating and so on.
Intervention MeSH terms: Fluvoxamine; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Mindfulness-Based Cognitive Therapy