Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT

Not Applicable

Recruiting

• Conditions: Obsessive Compulsive Disorder (OCD)
• Interventions: Other: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT); Other: Cognitive Behavioral Group Therapy (CBGT); Drug: conventional medical treatment (TAU)

• Registration Number: NCT06659094
• Lead Sponsor: Shanghai Mental Health Center

Brief 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?

Detailed Description

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 Timeline

• Study Start: 2024-08-21
• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-08-21
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication	stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)	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.
stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication	conventional medical treatment (TAU)	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.
Cognitive Behavioral Group Therapy (CBGT) combined with medication	Cognitive Behavioral Group Therapy (CBGT)	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.
Cognitive Behavioral Group Therapy (CBGT) combined with medication	conventional medical treatment (TAU)	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.

Primary Outcome Measures

Name	Time	Method
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)	Change from Baseline at 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change of Florida Obsessive-Compulsive Inventory (FOCI)	Change from Baseline at 6 weeks	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).
Change of Self-rating Depression Scale (SDS)	Change from Baseline at 6 weeks	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.
Change of Self-rating Anxiety Scale (SAS)	Change from Baseline at 6 weeks	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.
The University of Rhode Island Change Assessment	Change from Baseline at 6 weeks	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China