The Study of Mindfulness Based Cognitive Therapy and Obsessive-Compulsive Disorder

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

BEHAVIORAL

Mindfulness-based Cognitive Therapy

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.

BEHAVIORAL

Psycho-education Program

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.

DRUG

sertraline, fluvoxamine

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.

Sponsors & Collaborators

• Shanghai Mental Health Center

  lead OTHER

Principal Investigators

• Yifeng Shen, Senior · Shanghai Mental Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

54 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-20

Primary Completion

2018-11-20

Completion

2019-07-20

Countries

• China

Study Locations