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?
SC-ICBT is a therapy combining therapist-guided and semi-self-directed ICBT, with treatment plans adjusted based on patient symptoms. While it aims to be minimally restrictive and low-cost, research shows that low-intensity treatment may miss the mark for patients with severe symptoms or low motivation. High dropout rates and safety concerns are also noted. To address this, the investigators propose starting with high-intensity one-on-one support, reassessing symptoms in the third week, and switching to low-intensity self-guided practice if improvement is seen, otherwise continuing high-intensity support. In our study, the investigators will conduct a stepped-care Internet-based Cognitive Behavioral Therapy (ICBT) intervention trial with reduced support intensity: Following baseline symptom assessment (Week 0), participants will be allocated to either an online therapy group or an in-person group therapy group. Considering practicality, the study will employ a partially randomized allocation method: for participants who are convenient for both treatment modalities, the investigators will use random numbers to randomly assign them to either the online therapy group or the in-person group therapy group; if participants can only attend one of the treatment groups, the investigators will allocate them based on their preference. The group assignment will be blinded to the assessors. The study will feature two groups for a controlled trial: the experimental group, stepped-care ICBT combined with medication; the control group, cognitive-behavioral group therapy combined with medication. This study is conducted to explore the efficacy and cost-effectiveness of sc-ICBT with reduced support compared to CBGT in China. The investigators plan to recruit 80 patients and assign them to the SC-ICBT group and the CBGT group for a 6-week intervention, with a follow-up period of 3 months post-intervention. During this period, the investigators will employ questionnaires, scales, functional magnetic resonance imaging (fMRI), and other experimental methods to assess participants' obsessive-compulsive symptoms and treatment outcomes. Concurrently, the investigators will collect data on patients' economic burden and self-reported health status to evaluate the cost effect of SC-ICBT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
95
Using a WeChat mini-program, we offer personalized OCD SC-ICBT remote services. Training is customized based on individual assessments, focusing on psychological education and homework to simulate CBT therapy. If a patient's YBOCS score drop from baseline isn't 25% after four therapist sessions (one week of theory, two sessions/week), they get three more weeks of online guidance. The program includes four structured lessons over six weeks: Lesson 1: Psychological Health Education on OCD and related disorders. Lesson 2: ERP theory, exposure item lists, and related info. Lesson 3: Daily ERP practice for about an hour, followed by two weeks of therapist guidance. Lesson 4: Retrospection and relapse prevention.
The CBGT group will receive cognitive-behavioral group therapy for 6 weeks, twice a week, each session lasting 2 hours, at the Shanghai Mental Health Center. The CBGT program follows a structured process for treating OCD. During the prep phase, therapists assess patients for 50 minutes, collect data, and set CBGT groundwork. In Session 1, families join to understand CBGT, with goals reinforced and OCD education provided. Session 2 reviews homework and develops ERP strategies. Session 3 initiates ERP practice. Sessions 4-11 continue homework review and group ERP practice. The final session involves families in a review, discussing challenges, celebrating achievements, and focusing on relapse prevention.
Drug therapy, managed by a deputy chief psychiatrist unaware of patient groupings, utilizes China Food and Drug Administration (CFDA)-approved SSRIs for OCD. These include fluoxetine, paroxetine, sertraline, fluvoxamine, and others, with tricyclic drugs like clomipramine and SNRIs such as venlafaxine. The maximum dosage adheres to the instructions. Benzodiazepines may assist with sleep, but usage is capped at two weeks; no other psychotropics are co-administered. Common side effects comprise dry mouth, constipation, nausea, indigestion, dizziness, fatigue, and sweating. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)
YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity. Scores below 16 are considered mild or subclinical, 16 to 23 points indicate moderate severity, 24 to 31 points indicate severe severity, and scores above 31 indicate extremely severe.
Time frame: Change from Baseline at 6 weeks
Change of Florida Obsessive-Compulsive Inventory (FOCI)
FOCI, a self-rating scale, is used to assess the severity of obsessive-compulsive symptoms within one month, which contains 20 items. The first 15 items are evaluated the symptoms by yes and no, and the last 5 items are evaluated the severity of symptoms on 0-4 five-point scale. The Chinese version of the FOCI severity scale ≥8 is considered positive (i.e., indicative of obsessive-compulsive disorder).
Time frame: Change from Baseline at 6 weeks
Change of Self-rating Depression Scale (SDS)
The Self-Rating Depression Scale (SDS) was developed by William W. K. Zung from the Duke University School of Medicine in 1965 and is one of the most widely used self-assessment scales for depression. It is used to measure the severity of depressive states and their changes during treatment. According to the Chinese norm results, the cutoff value for the SDS standard score is 53 points, with 53-62 points indicating mild depression, 63-72 points indicating moderate depression, and above 73 points indicating severe depression. The normal upper limit for the SDS total raw score is 41 points, with lower scores indicating a better state. The standard score is the integer part obtained by multiplying the total raw score by 1.25. In China, a SDS standard score ≥50 is considered to have depressive symptoms.
Time frame: Change from Baseline at 6 weeks
Change of Self-rating Anxiety Scale (SAS)
The Self-rating Anxiety Scale (SAS) is very similar to the Self-rating Depression Scale (SDS) from the scale construction to the evaluation method. It is a very simple clinical tool to analyze the subjective anxiety symptoms of patients. It is suitable for adults with anxiety symptoms and has a wide range of application.According to the Chinese norm results, the cut-off value for SAS standard deviation is 50 points, with 50-59 points indicating mild anxiety, 60-69 points indicating moderate anxiety, and above 69 points indicating severe anxiety.
Time frame: Change from Baseline at 6 weeks
The University of Rhode Island Change Assessment
The University of Rhode Island Change Assessment (URICA) is a self-report measurement method developed by McConnaughy, DiClemente, Prochaska, and Velicer . The 24-item version consists of four dimensions: Precontemplation (Cronbach's α = 0.79), Contemplation (Cronbach's α = 0.84), Action (Cronbach's α = 0.84), and Maintenance (Cronbach's α = 0.82). URICA is commonly used to study motivation related to the treatment of behavioral health issues, and few studies have explored the specific relationship between the URICA scales and Cognitive Behavioral Therapy (CBT) for obsessive-compulsive disorder.For the general population, the following cut-off scores may be appropriate: 8 or lower classified as People in Precontemplation 8-11 classified as People in Contemplation 11-14 classified as People in Preparation or Action For intensive service populations, it may be more appropriate to use only score in the range of 12-14 to classify those in preparation and action.
Time frame: Change from Baseline at 6 weeks
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