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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
Yiwen Wu
wuyiwenhsd@163.com
+86 135 8590 0231
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 114
Treatments
Experimental: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication
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.
Active_comparator: Cognitive Behavioral Group Therapy (CBGT) combined with medication
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.
Active_comparator: conventional medical treatment (TAU)
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.
Related Therapeutic Areas
Obsessive-Compulsive Disorder (OCD)
Sponsors
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

Step Down from Maximal Support: Efficacy of Stepped-care Internet-based Cognitive Behavior Therapy for Obsessive-compulsive Disorder

Step Down from Maximal Support: Efficacy of Stepped-care Internet-based Cognitive Behavior Therapy for Obsessive-compulsive Disorder

Enrollment Status: Recruiting
Publish Date: November 12, 2024
Intervention Type: Other, Drug
Study Phase: Not Applicable

Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD

Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD

Enrollment Status: Recruiting
Publish Date: July 20, 2025
Intervention Type: Behavioral
Study Phase: Not Applicable

ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy from Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder

ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy from Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder

Enrollment Status: Recruiting
Publish Date: January 27, 2025
Intervention Type: Behavioral
Study Phase: Not Applicable
View All