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

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ClinicalTrials.gov Identifier: NCT03179839
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief 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.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Mindfulness-based Cognitive Therapy Behavioral: Psycho-education Program Drug: sertraline, fluvoxamine Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Study of Mindfulness Based Cognitive Therapy and Obsessive-Compulsive Disorder
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness-based Cognitive Therapy
MBCT group is a treatment group used mindfulness-based cognitive therapy, and guided by two therapists for 10 sessions. Every collection of about 6-8 patients is a closed structural group. Each session lasts 2.5 hours once a week, and has daily homework assignments.
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.


Placebo Comparator: Psycho-education Program
The program is consists of the information and principle of treatment for OCD, group sharing, supporting and discussion.
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.

Active Comparator: SSRIs Therapy
This is a control group that can choose to use SSRI drugs which the SFDA approved for the treatment of OCD (Sertraline, Fluvoxamine, initial dose of 50 mg).
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.




Primary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Scale [ Time Frame: Change from baseline up to week 34 ]
    Yale-Brown Obsessive-Compulsive Scale is a medical semi-structured questionnaire with a total of 10 items that measure the severity of Obsessive thinking and compulsive behavior on a scale of 0 = None; 1 = Sub-threshold; 2 =Mild; 3 =Moderate; and 4 = Severe. The total score is to be got by adding every score of all the items. And the higher the score is, the more severe OC symptoms are.


Secondary Outcome Measures :
  1. Hamilton Anxiety Scale [ Time Frame: Change from baseline up to week 34 ]
    Hamilton Anxiety Scale is the most common other-rating scale for clinical assessment of anxiety status and suitable for adults with anxiety symptoms. There are 14 items with each symptom rated on a five-point Scale.

  2. Hamilton Depression Scale-24 [ Time Frame: Change from baseline up to week 34 ]
    Hamilton Depression Scale-24 is the most common other-rating scale for clinically assessing the state of depression and suitable for adults with depressive symptoms. There are 24 items rated to each symptom and most of the items used 0 to 4 points.



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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants should suffer from clinically OCD symptoms and have a DSM-IV Axis Ⅰ diagnosis of OCD (M.I.N.I.)
  • 12≤ Y-BOCS score ≤25
  • Male or female, 18 years old to 54 years of age
  • Junior middle school education or above
  • Have not yet accepted psychiatric medication, or had received irregular medication treatment and have been discontinued 8 weeks
  • Have enough visual and acoustic ability to complete the inspection required for the study
  • Each patient and his guardian must understand the nature of this study and sign the informed consent form

Exclusion Criteria:

  • meet DSM-IV Axis Ⅰ diagnostic criteria for other psychiatric disorders
  • persons with severe physical disease or central nervous system disease
  • have a strong negative concept or a high risk of suicide
  • substance abuse, pregnancy or the preparation of recently pregnant women and lactating women
  • severe obsessive compulsive symptoms, so that patients can not complete the required assessment and treatment intervention
  • at the same time to accept MECT or other psychological therapy
  • patients had previously received treatment of mindfulness-based intervention, and no significant effect

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179839


Contacts
Contact: Yifeng Shen, Senior 13611890930 shenyifeng@yahoo.com

Locations
China, Shanghai
Clinical psychiatrist Recruiting
Shanghai, Shanghai, China, 200030
Contact: Haiyin Zhang, Senior    18017311201    haiyinz2001@126.com   
Contact: Qing Fan, Senior    18017311322    fanqing_98@sina.com   
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Study Director: Yifeng Shen, Senior Shanghai Mental Health Center

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03179839     History of Changes
Other Study ID Numbers: MBCT2017
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Mental Health Center:
Mindfulness-Based Cognitive Therapy

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Sertraline
Fluvoxamine
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors