The Study of the Pathogenesis and Cognitive Behavioral Group Therapy in Obsessive-Compulsive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02739061|
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : May 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Behavioral: cognitive behavioral group therapy Drug: sertraline, fluvoxamine Other: cognitive behavioral group therapy and drug therapy||Not Applicable|
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Shanghai Mental Health Center in China|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
Active Comparator: cognitive behavioral group therapy
cognitive behavioral group therapy
Behavioral: cognitive behavioral group therapy
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.
Active Comparator: drug therapy
Drug: sertraline, fluvoxamine
Select specified drugs (sertraline, fluvoxamine)
Active Comparator: The combination therapy
cognitive behavioral group therapy and drug therapy
Other: cognitive behavioral group therapy and drug therapy
Select specified drugs (sertraline, fluvoxamine) and start group cognitive behavior therapy for 12 weeks at the same time
- Y-BOCS (The Yale-Brown Obsessive Compulsive Scale) [ Time Frame: up to 6 months after treatment ]
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): NCT02739061
|Contact: Yifeng Shen, Seniorfirstname.lastname@example.org|
|Shanghai, Shanghai, China, 200030|
|Contact: Haiyin Zhang, Senior 18017311201 email@example.com|
|Contact: Qing Fan, Senior 18017311322 firstname.lastname@example.org|
|Study Director:||Yifeng Shen, Senior||Shanghai Mental Health Center|