Obsessive Compulsive Disorder (OCD)NCT06659094
Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT
A study testing stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (TAU) in people with Obsessive Compulsive Disorder (OCD), run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
- Obsessive-compulsive symptoms were too severe to participate in the experiment.
- High risk of suicide.
- Severe central system or physical disease
- Pregnant women or women that getting ready for being pregnant and lactating.
- Other treatments being performed.
- Uncooperative or unable to complete treatment
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Step Down From Maximal Support: Efficacy of Stepped-care Internet-based Cognitive Behavior Therapy for Obsessive-compulsive Disorder
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:
- 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)?
- Does SC-ICBT for obsessive-compulsive disorder offer better health economic benefits compared to CBGT?
- 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?
Read the 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.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT), conventional medical treatment (TAU)
- Keywords
- Obsessive Compulsive Disorder, Reduced-intensity stepped-care Internet-based Cognitive Behavioral Therapy, Randomized Controlled Trial, Cost effectiveness, Clinical Predictor
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)Other
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.
Cognitive Behavioral Group Therapy (CBGT)Other
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.
conventional medical treatment (TAU)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication | Experimental | 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. Receives: Other: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT); Drug: conventional medical treatment (TAU) |
| Cognitive Behavioral Group Therapy (CBGT) combined with medication | Active comparator | 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. Receives: Other: Cognitive Behavioral Group Therapy (CBGT); Drug: conventional medical treatment (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 6 weeks
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start21 Aug 2023
- Primary completion21 Aug 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Fan, Doctor, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659094
- Sponsor's protocol ID
- 2024-TX-004
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Down From Maximal Support: Efficacy of Stepped-care Internet-based Cognitive Behavior Therapy for Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT06659094
- Acronym / sponsor ID
- 2024-TX-004
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Obsessive Compulsive Disorder, Reduced-intensity stepped-care Internet-based Cognitive Behavioral Therapy, Randomized Controlled Trial, Cost effectiveness, Clinical Predictor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- Does SC-ICBT for obsessive-compulsive disorder offer better health economic benefits compared to CBGT?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication | Experimental | Other: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Drug: 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 | Active comparator | Other: Cognitive Behavioral Group Therapy (CBGT), Drug: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
- Obsessive-compulsive symptoms were too severe to participate in the experiment.
- High risk of suicide.
- Severe central system or physical disease
- Pregnant women or women that getting ready for being pregnant and lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)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. | Other | stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication |
| Cognitive Behavioral Group Therapy (CBGT)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. | Other | Cognitive Behavioral Group Therapy (CBGT) combined with medication |
| conventional medical treatment (TAU)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. | Drug | Cognitive Behavioral Group Therapy (CBGT) combined with medication, stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication |
Primary outcome
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time frame: 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.
4 secondary outcomes
Change of Florida Obsessive-Compulsive Inventory (FOCI)
Time frame: Change from Baseline at 6 weeks
Change of Self-rating Depression Scale (SDS)
Time frame: Change from Baseline at 6 weeks
Change of Self-rating Anxiety Scale (SAS)
Time frame: Change from Baseline at 6 weeks
The University of Rhode Island Change Assessment
Time frame: Change from Baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Fan, Doctor study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (TAU) in people with Obsessive Compulsive Disorder (OCD), run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS) (time frame: Change from Baseline at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.