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

Obsessive-Compulsive Disorder Clinical Trial

Official title: Shanghai Mental Health Center in China

Status Completed

Clinical Trial 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.

Clinical Trial Description

1. Case control study: At baseline, comparing the dimensions of clinical symptoms, genetics and imaging between OCD patients and healthy controls who were chosen into our study.

2. Randomized controlled single-blind study: The OCD patients are randomly assigned into pharmacological treatment, psychological treatment or pharmacological combined with psychological treatment. Psychological treatment: every six or so patients can establish a closed structured group. Each group will be treated for 12 sessions, for once a week, 120 minutes at a time. The 1-3 session will be psychological education on the topic of OCD and cognitive behavioral therapy; The 4-6 and 8-10 session will do step by step exposure and response prevention(ERP) training; the 7th an 11th session will invite family members or other caregivers of OCD patients for a education about OCD cognitive behavioral therapy to facilitate patients to complete ERP homework and give them some social supports; the final session will be self treatment evaluation and long-term treatment guidance. Pharmacological treatment: This study choose the SSRIs(Selective Serotonin Reuptake Inhibitor:sertraline, fluvoxamine, initial dose of 50 mg, the dose can be adjusted once a week, and the maximum dose should under the instruments ) approved by SFDA(China Food and Drug Administration) for OCD treatment which will last 12 weeks. Patients with sleep disorder can combined with Benzodiazepines less than two consecutive weeks; combination with other psychotropic drugs are forbidden. Pharmacological combined with psychological treatment: every six or so patients can establish a closed structured group which is same as the psychological treatment group; patients start to take medicine at the same time, use of the medicine is same as the pharmacological treatment group.

3. Follow-up study: After finishing the 12-week treatment, the OCD patients will be into a 6-month follow-up. Patients who are satisfied with pharmacological and/or psychological treatment will continue the current treatment, while others' follow-up treatment and specific treatment ways will be decided by researchers through the results of of our randomized controlled study. Our randomized controlled study results will be divided into valid and invalid groups. To the invalid psychological or pharmacological treatment group, patients will have a 12-week combined treatment which means invalid pharmacological treatment need to combine with psychological treatment and invalid psychological treatment need to combine with pharmacological treatment. Invalid pharmacological combined with psychological treatment should adjust the medicine (change with sertraline/fluvoxamine) and go on the psychological treatment. After the baseline assessment, OCD patients will have a follow-up evaluation at the 16th, 24th, and 36th week, while the healthy control will have a follow-up evaluation at the 12th and 36th week. ;

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

• NCT number: NCT02739061
• Study type: Interventional
• Source: Shanghai Mental Health Center
• Status: Completed
• Phase: N/A
• Start date: June 12, 2014
• Completion date: July 24, 2017