Clinical trial
Effect of Stepped Care in Internet-Based Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder：A Three-Arm Randomized Controlled Trial
Name
OCDICBT2022-36
Description
The goal of this clinical trial is to learn about the efficacy and cost-effectiveness of stepped-care Internet-based cognitive behavioral therapy (SC-ICBT) compared with Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (treatment as usual, TAU) in adults with obsessive-compulsive disorder (OCD) in China.
The main questions it aims to answer are:
question 1: Whether the efficacy of SC-ICBT is noninferior to CBGT and TAU for OCD?
question 2: Whether SC-ICBT is more cost-effective than CBGT and TAU for OCD?
Participants will receive treatment (SC-ICBT or CBGT or TAU) for 6 weeks.
Prior to the main study, we conduct a non-randomized pilot study to explore the efficacy and cost-effectiveness of SC-ICBT related to CBGT for adults with OCD in China.
Trial arms
Trial start
2022-09-01
Estimated PCD
2025-01-30
Trial end
2025-06-30
Status
Recruiting
Treatment
stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)
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: practice at least once a day, a day about one hour all together. On this basis, in the main study, 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. While in the pilot study, non-responders at week 3(YBOCS score reduction rate\<25%) will be provided with extra therapist-guided ICBT.
Lesson four: Practice retrospection and relapse prevention.
Arms:
stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication
Cognitive Behavioral Group Therapy (CBGT)
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. The structure of the course basically corresponds with the SC-ICBT group.
Arms:
Cognitive Behavioral Group Therapy (CBGT) combined with medication
conventional medical treatment (TAU)
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) as well as citalopram and escitalopram. The second-generation atypical antipsychotics may also be combined as a potentiator if the patient requires.
The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.
Arms:
Cognitive Behavioral Group Therapy (CBGT) combined with medication, conventional medical treatment (TAU), stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication
Size
114
Primary endpoint
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Change from Baseline at 6weeks
Eligibility criteria
Inclusion Criteria:
1. Age between 18 and 50 years
2. Satisfied with the diagnostic criteria for OCD in DSM-5.
3. 16≤YBOCS score ≤31
4. Taking medication stably for 8 weeks
5. Education level ⩾6 years
6. Has sufficient audiovisual skills to complete the necessary examinations for the study.
7. Right-handed (this criterion is for fMRI subjects only)
8. Subjects and their guardians understood the study and signed informed consent.
Exclusion Criteria:
1. Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
2. Obsessive-compulsive symptoms were too severe to participate in the experiment.
3. High risk of suicide.
4. Severe central system or physical disease
5. Pregnant women or women that getting ready for being pregnant and lactating.
6. Other treatments being performed.
7. Uncooperative or unable to complete treatment
8. 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 114, 'type': 'ESTIMATED'}}
Updated at
2024-01-23
1 organization
1 product
1 indication
Organization
Shanghai Mental Health CenterIndication
Obsessive-Compulsive Disorder