Effect of Stepped Care in Internet-Based Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder：A Three-Arm Randomized Controlled Trial
Trial testing online therapy for adults with OCD terminated.
Plain English Summary
Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial is a Not Applicable clinical trial sponsored by Shanghai Mental Health Center studying Obsessive-Compulsive Disorder. This trial tested an online therapy program (SC-ICBT) against group therapy and standard care for adults with Obsessive-Compulsive Disorder (OCD). It was designed for adults in China aged 18-50 who have been diagnosed with OCD and have stable medication for at least 8 weeks. Participants received one of three treatments for 6 weeks: online therapy, group therapy, or standard medical care. The trial was terminated early, so results on effectiveness and cost-effectiveness are not available. The trial aims to enroll 46 participants.
Official Summary
The goal of this clinical trial is to learn about the efficacy and cost-effectiveness of stepped-care Internet-based cognitive behavioral therapy (SC-ICBT) compared with Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (treatment as usual, TAU) in adults with obsessive-compulsive disorder (OCD) in China. The main questions it aims to answer are: question 1: Whether the efficacy of SC-ICBT is noninferior to CBGT and TAU for OCD? question 2: Whether SC-ICBT is more cost-effective than CBGT and TAU for OCD? Participants will receive treatment (SC-ICBT or CBGT or TAU) for 6 weeks. Prior to the main study, we conduct a non-randomized pilot study to explore the efficacy and cost-effectiveness of SC-ICBT related to CBGT for adults with OCD in China.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 to 50 years old. Individuals diagnosed with Obsessive-Compulsive Disorder (OCD) with a specific symptom severity score. People who have been taking their current medication for OCD stably for at least 8 weeks. Individuals with at least 6 years of education and the ability to use audiovisual equipment. This trial is studying Obsessive-Compulsive Disorder, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measured how much participants' OCD symptoms improved on a standard scale after 6 weeks of treatment, indicating the treatment's effectiveness. The specific primary outcome measures are: Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS) (Change from Baseline at 6weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aimed to find a potentially more accessible and cost-effective online treatment option for adults with OCD, addressing a gap in readily available mental health services. This research targets Obsessive-Compulsive Disorder, where improved treatment options are needed.
Investor Insight
The trial's termination suggests potential challenges in recruitment or execution, which could impact investor confidence in this specific approach or sponsor's trial management capabilities.
Is This Trial Right for Me?
Ask your doctor if online therapy is a suitable option for your specific OCD symptoms and if it's safe to switch or adjust your current treatment. Understand that participation involved receiving one of three treatments for 6 weeks, which could include online lessons, in-person group sessions, or standard medical care. Be aware that the trial was terminated early, meaning the planned comparisons between treatments were not fully completed. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 46 participants
Interventions
- OTHER: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) — OCD patients will take part in four structured online lessons for 6 weeks. Lesson one: Psychological Health Education, including the knowledge about OCD, SUDs and other related information. Lesson two: Exposure and Response Prevention (ERP), including the knowledge about ERP, exposure item list and other related information. Lesson three: Practice of Exposure and Response Prevention. Patients are asked to perform ERP practice based on what they have learned previously: practice at least once a
- OTHER: Cognitive Behavioral Group Therapy (CBGT) — OCD patients will be asked to come to Shanghai Mental Health Center to take part in the offline CBT group. Each group will be treated for 6 weeks, twice a week for 2 hours each time. The treatment was supervised by an experienced CBGT therapist. The structure of the course basically corresponds with the SC-ICBT group.
- DRUG: conventional medical treatment (TAU) — In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline and fluvoxamine) as well as citalopram and escitalopram. The second-generation atypical antipsychotics may also be combined as a potentiator if the patient requires. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.
Primary Outcomes
- Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS) (Change from Baseline at 6weeks)
Secondary Outcomes
- Change of Florida Obsessive-Compulsive Inventory (FOCI) (Change from Baseline at 6weeks)
- Change of Self-rating Depression Scale (SDS) (Change from Baseline at 6weeks)
- Change of Self-rating Anxiety Scale (SAS) (Change from Baseline at 6weeks)
Full Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 50 years 2. Satisfied with the diagnostic criteria for OCD in DSM-5. 3. 16≤YBOCS score ≤31 4. Taking medication stably for 8 weeks 5. Education level ⩾6 years 6. Has sufficient audiovisual skills to complete the necessary examinations for the study. 7. Right-handed (this criterion is for fMRI subjects only) 8. Subjects and their guardians understood the study and signed informed consent. 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)
Trial Locations
- Shanghai Mental Health Center, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
What is clinical trial NCT05528224?
NCT05528224 is a Not Applicable INTERVENTIONAL study titled "Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial." It is currently terminated and is sponsored by Shanghai Mental Health Center. The trial targets enrollment of 46 participants.
What conditions does NCT05528224 study?
This trial investigates treatments for Obsessive-Compulsive Disorder. The primary condition under study is Obsessive-Compulsive Disorder.
What treatments are being tested in NCT05528224?
The interventions being studied include: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) (OTHER), Cognitive Behavioral Group Therapy (CBGT) (OTHER), conventional medical treatment (TAU) (DRUG). OCD patients will take part in four structured online lessons for 6 weeks. Lesson one: Psychological Health Education, including the knowledge about OCD, SUDs and other related information. Lesson two: Exposure and Response Prevention (ERP), including the knowledge about ERP, exposure item list and other related information. Lesson three: Practice of Exposure and Response Prevention. Patients are asked to perform ERP practice based on what they have learned previously: practice at least once a
What does Not Applicable mean for NCT05528224?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05528224?
This trial is currently "Terminated." It started on 2022-09-01. The estimated completion date is 2024-03-31.
Who is sponsoring NCT05528224?
NCT05528224 is sponsored by Shanghai Mental Health Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05528224?
The trial aims to enroll 46 participants. The trial status is terminated.
How is NCT05528224 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05528224?
The primary outcome measures are: Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS) (Change from Baseline at 6weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05528224 being conducted?
This trial is being conducted at 1 site, including Shanghai, Shanghai Municipality (China).
Where can I find official information about NCT05528224?
The official record for NCT05528224 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05528224. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05528224 testing in simple terms?
This trial tested an online therapy program (SC-ICBT) against group therapy and standard care for adults with Obsessive-Compulsive Disorder (OCD). It was designed for adults in China aged 18-50 who have been diagnosed with OCD and have stable medication for at least 8 weeks.
Why is this trial significant?
This trial aimed to find a potentially more accessible and cost-effective online treatment option for adults with OCD, addressing a gap in readily available mental health services.
What are the potential risks of participating in NCT05528224?
Potential side effects of online therapy could include frustration with technology or difficulty engaging with the material without in-person support. Standard treatments like SSRIs can have side effects such as nausea, insomnia, or sexual dysfunction. Group therapy might involve discomfort sharing personal experiences in a group setting. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05528224?
Ask your doctor if online therapy is a suitable option for your specific OCD symptoms and if it's safe to switch or adjust your current treatment. Understand that participation involved receiving one of three treatments for 6 weeks, which could include online lessons, in-person group sessions, or standard medical care. Be aware that the trial was terminated early, meaning the planned comparisons between treatments were not fully completed. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05528224 signal from an investment perspective?
The trial's termination suggests potential challenges in recruitment or execution, which could impact investor confidence in this specific approach or sponsor's trial management capabilities. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants received one of three treatments for 6 weeks: online therapy, group therapy, or standard medical care. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.