The Study of the Pathogenesis and Cognitive Behavioral Group Therapy in Obsessive-Compulsive Disorder

NCT02739061 | Completed

• 1 other identifier: HYZhang
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to explore the pathogenesis of obsessive-compulsive disorder(OCD) by using biological technologies such as genetics and imaging, and to evaluate the efficacy of group cognitive behavioural therapy in OCD among the Chinese people. We also prepare to explore the synergistic effect of the pharmacological treatment combined with group cognitive behavioural therapy in OCD, and to find the biological and psychological index which can predict curative effect. This research includes case control study and randomized controlled single-blind study. At baseline, we compare the dimensions of clinical symptoms, genetics and imaging between OCD patients and healthy controls. The OCD patients are randomly assigned into pharmacological treatment, psychological treatment or pharmacological combined with psychological treatment for a 12-week treatment. After a 12-week treatment, the OCD patients will be divided into valid and invalid groups according to the results of our randomized controlled study by researchers: to our valid group, patients will continue the current treatment, and to the invalid psychological or pharmacological treatment group, patients will have a 12-week combined treatment. From the baseline, we will have a 9-month follow up for both OCD patients and healthy controls.

Conditions

Obsessive-Compulsive Disorder

Keywords

pathogenesis; cognitive behavioral group therapy

Outcome Measures

Primary Outcomes (1)

• Y-BOCS (The Yale-Brown Obsessive Compulsive Scale)

  up to 6 months after treatment

Study Arms (3)

cognitive behavioral group therapy

ACTIVE COMPARATOR

cognitive behavioral group therapy

Behavioral: cognitive behavioral group therapy

drug therapy

ACTIVE COMPARATOR

drug therapy

Drug: sertraline, fluvoxamine

The combination therapy

ACTIVE COMPARATOR

cognitive behavioral group therapy and drug therapy

Other: cognitive behavioral group therapy and drug therapy

Interventions

cognitive behavioral group therapy BEHAVIORAL

Establish closed every collection of six or so patients structured group. Each group patients were treated for 12 times, once a week, 120 minutes at a time. Treatment for 1 to 3 times to obsessive-compulsive disorder and cognitive behavioral therapy as the theme of psychological education; 4 to 6, 8 to 10 times exposed step by step and reaction treatment and prevention of training;7 and 11 times invite patients family members or other caregivers, make education about obsessive-compulsive disorder cognitive behavioural therapy, to promote patients exposed response prevention homework completion and social support; The 12th time treatment is self assessment and treatment guidelines for a long time.

cognitive behavioral group therapy

sertraline, fluvoxamine DRUG

Select specified drugs (sertraline, fluvoxamine)

drug therapy

cognitive behavioral group therapy and drug therapy OTHER

Select specified drugs (sertraline, fluvoxamine) and start group cognitive behavior therapy for 12 weeks at the same time

The combination therapy

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• OCD patients： Among 18 to 54 years old, males or females； See a doctor because of OCD recently，conform to DSM-Ⅳ(Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria of OCD; The scores of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is not less than 16 points; Has not yet accepted psychiatric medication or have received irregular medication treatments and discontinuation for at least eight weeks; A junior high school and above level of education; Has enough of seeing and hearing level to complete the necessary checks; Right-handed (this standard is limited to magnetic resonance imaging (MRI) detection); The Han nationality (this standard is limited to genetic testing); Willing to participate in this study..
• Healthy controls： 1:1 match with the OCD group in age, gender and level of education; Never appear symptoms of OCD, not comply with obsessive compulsive disorder, or other mental disorders DSM-Ⅳ diagnostic criteria; There is no history of psychiatric medication; No two lines three generations of history of mental disorder; Has enough of seeing and hearing level to complete the necessary checks; Right-handed (this standard is limited to magnetic resonance imaging (MRI) detection); The Han nationality (this standard is limited to genetic testing); Willing to participate in this study.

You may not qualify if:

• OCD patients： Conform to the DSM-Ⅳ other axis I except obsessive-compulsive disorder diagnosis (M.I.N.I evaluation screening); Patients will not be able to complete the required assessment check and cognitive behavioural therapy because of the severe OCD symptoms; There is negative or a higher risk of suicide; Currently suffering from serious physical disease or central nervous system disease, substance abuse; Pregnant woman or woman who is ready to be pregnant, and lactating women; Used to have received a full course of cognitive behavioral therapy, and no significant curative effect; In presence of metallic implants: install pacemaker, intracranial silver clip, metal false teeth, stents, artery clamp, joints, metal fixed, or other metal implants in (this standard is limited to magnetic resonance imaging (MRI) detection).
• Healthy controls： There is negative or a higher risk of suicide; Currently suffering from serious physical disease or central nervous system disease, substance abuse; Pregnant woman or woman who is ready to be pregnant, and lactating women; In presence of metallic implants: install pacemaker, intracranial silver clip, metal false teeth, stents, artery clamp, joints, metal fixed, or other metal implants in (this standard is limited to magnetic resonance imaging (MRI) detection).

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

Sertraline; Fluvoxamine; Drug Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Oximes; Hydroxylamines; Therapeutics

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: April 12, 2016
• First Posted: April 14, 2016
• Study Start: June 12, 2014
• Primary Completion: March 8, 2017
• Study Completion: July 24, 2017
• Last Updated: January 7, 2020

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)