Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial
Key facts
- Who runs it
- Shanghai Mental Health Center
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 46 people enrolled
- Started
- 1 Sept 2022
- Ended
- 31 Mar 2024
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)
- Cognitive Behavioral Group Therapy (CBGT)
- conventional medical treatment (TAU)
- Record updated
- 21 January 2026
- Why it stopped
- Main trial terminated after pilot trial: full randomization proved infeasible for nonlocal participants; baseline symptom-based allocation added confounding variable; comparison with CBGT alone was deemed sufficient to assess SC-ICBT effectiveness
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age between 18 and 50 years
- Satisfied with the diagnostic criteria for OCD in DSM-5
- 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
Who cannot take part
- 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)
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD
- Severe central system or physical disease
- Obsessive-compulsive symptoms were too severe to participate in the experiment
- High risk of suicide
- Pregnant women or women that getting ready for being pregnant and lactating
- Other treatments being performed
- Uncooperative or unable to complete treatment
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medicationTreatment being tested
In the main study, 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. In the pilot study, 23 OCD patients will be assigned to SC-ICBT group based on their autonomous will. They will begin with self-guided ICBT, followed by an assessment of their treatment outcomes at week 3, with non-responders being escalated to a higher intensity of treatment, and additional therapist-guided ICBT in the following three weeks. During the 6-week treatment they will continue with the medications they already have.
Treatment: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) and conventional medical treatment (TAU)
- Cognitive Behavioral Group Therapy (CBGT) combined with medicationExisting treatment, for comparison
In the main study, OCD patients will be provided with therapist-guided offline Cognitive Behavioral Group Therapy while they will continue with the medications they already have. In the pilot study, 23 OCD patients will be assigned to CBGT group based on their autonomous will. They will receive the same CBGT intervention as in the main study while they will continue with the medications they already have.
Treatment: Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (TAU)
- conventional medical treatment (TAU)Existing treatment, for comparison
In the main study, OCD patients will be treated as usual. Namely, they will continue with the medications they already have. This group is not present in the pilot study, as both SC-ICBT group and CBGT group combines medications. We suppose that the mere use of SC-ICBT group compared to CBGT group (a commonly used psychotherapy in Chinese clinical practice) is sufficient to draw conclusions about the feasibility of SC-ICBT in in adults with OCD in China. However, in order to further validate the economic benefits of SC-ICBT, we chose to set TAU group in the main study.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Stepped Care in Internet-Based Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder：A Three-Arm Randomized Controlled Trial
- Record updated
- 21 January 2026