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

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

This study is conducted to explore the efficacy and cost-effectiveness of stepped-care internet-based cognitive behavior therapy (sc-ICBT) with reduced support compared to cognitive-behavioral group therapy(CBGT), to identify the optimal transition points for shorter effective stepped treatments, to find clinical indicators that can predict the effectiveness of CBT interventions, and to investigate predictive outcomes. The main questions the investigators aim to answer are: 1. Is the reduction in YBOCS scores following stepped-care Internet-based cognitive-behavioral therapy (SC-ICBT) with reduced support non-inferior to that observed in traditional cognitive-behavioral group therapy (CBGT)? 2. Does SC-ICBT for obsessive-compulsive disorder offer better health economic benefits compared to CBGT? 3. What is the optimal time point for transitioning to shorter effective stepped care, and what clinical indicators can predict the efficacy of CBT interventions post-treatment?

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

• Individuals aged between 18 and 50 years, inclusive of both genders;

• 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);

• Yale-Brown Obsessive Compulsive Scale (YBOCS) scores ranging from 16 to 31, inclusive;

• Have been on a stable regimen of standard anti-compulsive pharmacotherapy for a period of 8 weeks;

• Possess a minimum educational level of junior high school;

• Demonstrate adequate auditory and visual acuity to perform the assessments required by the study;

• The participant and their legal guardian have comprehended the nature of the study and have provided informed consent;

• Right-handedness (this criterion applies exclusively to participants undergoing magnetic resonance imaging).

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
Yuhan Yang
tina_yyh2001@163.com
+86 18059856706
Time Frame
Start Date: 2024-08-21
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 80
Treatments
Experimental: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication
Patients' OCD severity is initially assessed with the Yale-Brown Obsessive Compulsive Scale (YBOCS). After enrollment, patients receive health education, observe symptoms, learn ERP theory, and create exposure lists on a WeChat mini-program for pre-treatment. They perform daily 1-hour ERP exercises for a week, with online status collection by coordinators. After a week, patients receive twice-weekly online ERP guidance from therapists for two weeks.~After two and four therapy sessions, YBOCS re-evaluations occur via Tencent Meeting. Based on scores, the next three weeks involve either self-guided ERP or a mix of self-guided and therapist-guided ERP. If patients show over a 25% reduction, therapist guidance is suspended, and they switch to self-guided ICBT for the final three weeks.
Active_comparator: Cognitive Behavioral Group Therapy (CBGT) combined with medication
OCD patients will be provided with therapist-guided offline Cognitive Behavioral Group Therapy while they will continue with the medications they already have.~A nationally registered psychotherapist, who has undergone systematic professional training, is in charge of a homogeneous closed group and records the sessions live. The treatment takes place in the group psychotherapy room at the Shanghai Mental Health Center, with a group of 6 people, for 6 weeks, twice a week, each session lasting 2 hours. A senior domestic group cognitive therapist supervises the treatment.
Sponsors
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov