Online therapy for obsessive-compulsive disorder with reduced support

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

This study is testing whether an online therapy program for obsessive-compulsive disorder with less support can be as effective and cost-efficient as traditional group therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06659094 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and cost-efficiency of stepped-care internet-based cognitive behavioral therapy (sc-ICBT) with reduced support compared to traditional cognitive-behavioral group therapy (CBGT) for patients with obsessive-compulsive disorder (OCD). Participants will be randomly assigned to either an online therapy group or an in-person group therapy group, with treatment intensity adjusted based on symptom improvement. The study aims to identify optimal transition points for treatment and clinical indicators that predict the effectiveness of CBT interventions. The approach combines therapist guidance with self-directed practices to enhance accessibility and reduce costs.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 50 with OCD symptoms that meet DSM-5 criteria and specific YBOCS score ranges.

Not a fit: Patients with other mental disorders or those not meeting the specific OCD criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and cost-efficient treatment option for patients with OCD.

How similar studies have performed: Other studies have shown promise with internet-based CBT approaches, but this specific stepped-care model is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Individuals aged between 18 and 50 years, inclusive of both genders;
2. Presenting primarily with compulsive symptoms that meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Obsessive-Compulsive Disorder (OCD);
3. Yale-Brown Obsessive Compulsive Scale (YBOCS) scores ranging from 16 to 31, inclusive;
4. Have been on a stable regimen of standard anti-compulsive pharmacotherapy for a period of 8 weeks;
5. Possess a minimum educational level of junior high school;
6. Demonstrate adequate auditory and visual acuity to perform the assessments required by the study;
7. The participant and their legal guardian have comprehended the nature of the study and have provided informed consent;
8. Right-handedness (this criterion applies exclusively to participants undergoing magnetic resonance imaging).

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)

Where this trial is running

Shanghai, Shanghai

• Shanghai Mental Health Center — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Yuhan Yang

Conditions: Obsessive Compulsive Disorder, Reduced-intensity stepped-care Internet-based Cognitive Behavioral Therapy, Randomized Controlled Trial, Cost effectiveness, Clinical Predictor