Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial

Study Overview
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Brief Summary
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This study aims to investigate the efficacy and cost-effectiveness of SC-ICBT related to CBGT and TAU for adults with OCD in China.

Detailed Description
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Internet-based cognitive Behavioral therapy (ICBT) integrates the Internet and cognitive behavioral therapy, which enables patients to participate in different treatment modules online. ICBT has been proved to be an effective way to improve the symptoms of OCD patients with lower cost. In the study, the investigators plan to develop an intervention pattern of stepped care in Internet-Based cognitive behavioral therapy (SC-ICBT): After individualized assessment（0 week and 3 week separately）, OCD patients will be provided with self-guided ICBT or therapist-guided ICBT through the severity of their symptoms flexibly. This study will be a randomized, controlled, assessor-blinded trial of three groups in the obsessive-compulsive disorder: Stepped Care in Internet-based Cognitive Behavioral Therapy (SC-ICBT) combined with medication, Cognitive Behavioral Group Therapy (CBGT) combined with medication, and conventional medical treatment (TAU). The study aims to investigate the efficacy and cost-effectiveness of SC-ICBT related to CBGT and TAU for adults with OCD in China. The investigators plan to recruit 114 OCD patients and randomly assigns them to the SC-ICBT group, CBGT group, and TAU group for treatment of 6 weeks and follow-up of 3 months in the study. Questionnaires, scales, behavior experiments and other experimental materials will be used to evaluate the intervention effect of 6-week SC-ICBT on obsessive and compulsive symptoms, cognitive function and quality of life of OCD patients as well as patients' and therapists' cost.

Official Title
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Effect of Stepped Care in Internet-Based Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder：A Three-Arm Randomized Controlled Trial

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Other: stepped care in Internet-based cognitive Behavioral therapy(SC-ICBT)
* Other: Cognitive Behavioral Group Therapy (CBGT)
* Drug: conventional medical treatment (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 50 years Satisfied with the diagnostic criteria for OCD in DSM-V. 16≤YBOCS score ≤31 Taking medication stably for 8 weeks Education level ⩾6 years Has sufficient audiovisual skills to complete the necessary examinations for the study. Right-handed (this criterion is for fMRI subjects only) Subjects and their guardians understood the study and signed informed consent. Exclusion Criteria: Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD. Obsessive-compulsive symptoms were too severe to participate in the experiment. High risk of suicide. Severe central system or physical disease Pregnant women or women that getting ready for being pregnant and lactating. Other treatments being performed. Uncooperative or unable to complete treatment With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stepped care in Internet-based cognitive Behavioral therapy(SC-ICBT) combined with medication<br>After individualized assessment（0 week and 3 week separately）, OCD patients will be provided with self-guided ICBT or therapist-guided ICBT through the severity of their symptoms flexibly while they will continue with the medications they already have. | Other: stepped care in Internet-based cognitive Behavioral therapy(SC-ICBT)<br>* OCD patients will take part in four structured online lessons for 6 weeks. Lesson one: Psychological Health Education, including the knowledge about OCD, SUDs and other related information. Lesson two: Exposure and Response Prevention (ERP), including the knowledge about ERP, exposure item list and other related information. Lesson three: Practice of Exposure and Response Prevention. Patients are asked to perform ERP practice based on what they have learned previously: practise at least once a day, a day about one hour all together. On this basis, patients with severe obsessive and compulsive symptoms(Y-BOCS≥24) will be provided with extra therapist-guided ICBT: twice a week, about an hour one time. Lesson four: Practice retrospection and relapse prevention.<br>Drug: conventional medical treatment (TAU)<br>* In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline, and fluvoxamine). The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.<br>|
| Active Comparator: Cognitive Behavioral Group Therapy (CBGT) combined with medication<br>OCD patients will be provided with therapist-guided offline Cognitive Behavioral Group Therapy while they will continue with the medications they already have. | Other: Cognitive Behavioral Group Therapy (CBGT)<br>* OCD patients will be asked to come to Shanghai Mental Health Center to take part in the offline CBT group. Each group will be treated for 6 weeks, twice a week for 2 hours each time. The treatment was supervised by an experienced CBGT therapist.<br>Drug: conventional medical treatment (TAU)<br>* In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline, and fluvoxamine). The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.<br>|
| Active Comparator: conventional medical treatment (TAU)<br>OCD patients will be treated as usual. Namely, they will continue with the medications they already have. | Drug: conventional medical treatment (TAU)<br>* In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline, and fluvoxamine). The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS) | YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity. | Change from Baseline at 6weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Florida Obsessive-Compulsive Inventory (FOCI) | FOCI, a self-rating scale, is used to assess the severity of obsessive-compulsive symptoms within one month, which contains 20 items. The first 15 items are evaluated the symptoms by yes and no, and the last 5 items are evaluated the severity of symptoms on 0-4 five-point scale. | Change from Baseline at 6weeks | 
| Change of Self-rating Depression Scale (SDS) | Self-rating Depression Scale (SDS) was developed by William W. K. Zung of Duke University Medical School in 1965. It is one of the most widely used self-rating depression scales. It is used to measure the severity of depression and its change in treatment. | Change from Baseline at 6weeks | 
| Change of Self-rating Anxiety Scale (SAS) | The Self-rating Anxiety Scale (SAS) is very similar to the Self-rating Depression Scale (SDS) from the scale construction to the evaluation method. It is a very simple clinical tool to analyze the subjective anxiety symptoms of patients. It is suitable for adults with anxiety symptoms and has a wide range of application. | Change from Baseline at 6weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-Compulsive Disorder, Stepped Care in Internet-based Cognitive Behavioral Therapy, Cost-effectiveness, Randomized Controlled Trial