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

NCT03179839 | Completed

• 1 other identifier: MBCT2017
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Mindfulness-Based Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale

  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.

  Change from baseline up to week 34

Secondary Outcomes (2)

• Hamilton Anxiety Scale

  Change from baseline up to week 34

• Hamilton Depression Scale-24

  Change from baseline up to week 34

Study Arms (3)

Mindfulness-based Cognitive Therapy

EXPERIMENTAL

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

Psycho-education Program

PLACEBO COMPARATOR

The program is consists of the information and principle of treatment for OCD, group sharing, supporting and discussion.

Behavioral: Psycho-education Program

SSRIs Therapy

ACTIVE COMPARATOR

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

Interventions

Mindfulness-based Cognitive Therapy BEHAVIORAL

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.

Mindfulness-based Cognitive Therapy

Psycho-education Program BEHAVIORAL

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.

Psycho-education Program

sertraline, fluvoxamine DRUG

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.

SSRIs Therapy

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants should suffer from clinically OCD symptoms and have a DSM-IV Axis Ⅰ diagnosis of OCD (M.I.N.I.)
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Clinical psychiatrist

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Mindfulness-Based Cognitive Therapy; Sertraline; Fluvoxamine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Oximes; Hydroxylamines

Study Officials

• Yifeng Shen, Senior

  Shanghai Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: June 7, 2017
• Study Start: January 20, 2017
• Primary Completion: November 20, 2018
• Study Completion: July 20, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)