Effect of a Family-Based Cognitive Behavioral Therapy Self-Help Intervention for Adolescents With Obsessive-Compulsive Disorder：A Randomized Controlled Trial
Adolescent OCD Trial Tests Self-Help Book with Medication
Plain English Summary
Effect of a Family-Based CBT Self-Help Intervention for Adolescents With OCD is a Not Applicable clinical trial sponsored by Shanghai Mental Health Center studying Obsessive - Compulsive Disorder. This study tests if a self-help book can improve obsessive-compulsive disorder (OCD) symptoms in teens already taking medication. It is for adolescents aged 10-17 with OCD who are on stable medication. Participants will read a chapter and do exercises from a self-help book weekly for 12 weeks, alongside their current medication. The alternative is continuing medication alone. The trial aims to enroll 88 participants.
Official Summary
The goal of this clinical trial is to learn if self-help book can be used to treat obsessive-compulsive disorder (OCD) in adolescents aged 10 to 17. The main questions it aims to answer are: Can adolescents and their parents effectively reduce the severity of the obsessive-compulsive symptoms in adolescents who are already stably taking medications through self-help books? What are the characteristics of adolescents who are best suited to use self-help intervention book to treat obsessive-compulsive symptoms? Researchers will compare the use of a self-help books plus medication with medication alone to see if the combination of the self-help intervention and drug treatment can improve the obsessive-compulsive symptoms of adolescents more effectively. Participants will: * Read one chapter of a self-help book and complete the corresponding exercise each week for 12 weeks * Visit the clinic before and after intervention for checkups and tests
Who Can Participate
Here is what you need to know about eligibility for this trial. Teens aged 10-17 with a moderate OCD diagnosis (CY-BOCS score 16-23) can join. Participants must have been on stable medication for at least 6 weeks and have parents who can participate. Teens with severe OCD (CY-BOCS score 24+), high suicide risk, certain other mental health conditions, or recent CBT treatment are not eligible. Individuals with IQ below 80 or those undergoing other treatments may also be excluded. This trial is studying Obsessive - Compulsive Disorder, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how much OCD symptoms improve on a standardized scale, indicating whether the self-help book makes a meaningful difference for teens. The specific primary outcome measures are: Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score (Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)). 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 addresses a need for accessible, potentially lower-cost OCD treatments for adolescents by evaluating a self-help book intervention to complement existing medication. This research targets Obsessive - Compulsive Disorder, where improved treatment options are needed.
Investor Insight
This trial explores a novel, potentially scalable intervention for adolescent OCD, a significant market, with a high probability of informing future treatment guidelines if successful.
Is This Trial Right for Me?
Ask your doctor if this self-help approach is right for your child, especially considering their current medication and OCD severity. Participation involves weekly reading and exercises from a self-help book for 12 weeks, with regular clinic visits for checkups. Parents or guardians must be able to accompany the adolescent throughout the intervention. This trial is currently recruiting participants. 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: 88 participants
Interventions
- DRUG: conventional medical treatment (TAU) — In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs, i.e., sertraline, fluoxetine and fluvoxamine)and tricyclic drugs(i.e., clomipramine) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD in children and adolescents. The drugs used in this study are commonly used in clinical practice and have a good safety profile. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual, or the maximum dosage tol
- BEHAVIORAL: Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder — The self-help book used in this study was independently developed by members of our research team. Its content is based on Exposure and Response Prevention (ERP). Adolescent patients with OCD will be instructed to read one chapter of the self-help book each week and complete the corresponding exercises. This 12-week intervention will involve self-guided practice conducted by the adolescent and their family members.Throughout the intervention period, adolescents and their caregivers may contact t
Primary Outcomes
- Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score (Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up))
Secondary Outcomes
- Change in Children's Depression Inventory (CDI) Total Score (Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up))
- Change in Obsessive-Compulsive Inventory - Child Version (OCI-CV) Total Score (Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up))
- Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score (Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up))
- Clinical Global Impression - Improvement (CGI-I) (Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up))
- Clinical Global Impression - Severity (CGI-S) (Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up))
Full Eligibility Criteria
Inclusion Criteria: 1. Age between 10 and 17 years 2. Satisfied with the diagnostic criteria for OCD in DSM-5 3. 16≤CY-BOCS score ≤23 4. Taking medication stably for 6 weeks 5. Education level ⩾6 years 6. At least one parent can accompany the patients throughout the entire intervention process 7. The patient and the participating parent have sufficient reading and writing skills to complete the treatment intervention 8. The patient and the participating parent have adequate auditory and visual abilities 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. Obsessive-compulsive symptoms were too severe to participate in the experiment(CY-BOCS score ≥24) 2. High risk of suicide 3. Comorbid brain organic diseases, severe somatic diseases, learning disabilities, autism spectrum disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder, severe eating disorders, or substance abuse 4. Completed a Cognitive Behavioral Therapy (CBT) course for OCD within the past 12 months. 5. An IQ lower than 80 6. Currently undergoing other psychological/physical treatments 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, Xuhui, Shanghai Municipality, China
Frequently Asked Questions
What is clinical trial NCT06942494?
NCT06942494 is a Not Applicable INTERVENTIONAL study titled "Effect of a Family-Based CBT Self-Help Intervention for Adolescents With OCD." It is currently recruiting and is sponsored by Shanghai Mental Health Center. The trial targets enrollment of 88 participants.
What conditions does NCT06942494 study?
This trial investigates treatments for Obsessive - Compulsive Disorder. The primary condition under study is Obsessive - Compulsive Disorder.
What treatments are being tested in NCT06942494?
The interventions being studied include: conventional medical treatment (TAU) (DRUG), Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder (BEHAVIORAL). In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs, i.e., sertraline, fluoxetine and fluvoxamine)and tricyclic drugs(i.e., clomipramine) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD in children and adolescents. The drugs used in this study are commonly used in clinical practice and have a good safety profile. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual, or the maximum dosage tol
What does Not Applicable mean for NCT06942494?
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 NCT06942494?
This trial is currently "Recruiting." It started on 2025-04-30. The estimated completion date is 2027-12-31.
Who is sponsoring NCT06942494?
NCT06942494 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 NCT06942494?
The trial aims to enroll 88 participants. The trial is currently recruiting and accepting new participants.
How is NCT06942494 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 NCT06942494?
The primary outcome measures are: Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score (Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06942494 being conducted?
This trial is being conducted at 1 site, including Xuhui, Shanghai Municipality (China).
Where can I find official information about NCT06942494?
The official record for NCT06942494 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06942494. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06942494 testing in simple terms?
This study tests if a self-help book can improve obsessive-compulsive disorder (OCD) symptoms in teens already taking medication. It is for adolescents aged 10-17 with OCD who are on stable medication.
Why is this trial significant?
This trial addresses a need for accessible, potentially lower-cost OCD treatments for adolescents by evaluating a self-help book intervention to complement existing medication.
What are the potential risks of participating in NCT06942494?
The main risk is that the self-help intervention may not be effective for some individuals, leading to continued OCD symptoms. Potential side effects are generally related to the underlying OCD or current medications, rather than the self-help book itself. Some participants might find the exercises challenging or experience temporary increases in distress as they confront their obsessions and compulsions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06942494?
Ask your doctor if this self-help approach is right for your child, especially considering their current medication and OCD severity. Participation involves weekly reading and exercises from a self-help book for 12 weeks, with regular clinic visits for checkups. Parents or guardians must be able to accompany the adolescent throughout the intervention. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06942494 signal from an investment perspective?
This trial explores a novel, potentially scalable intervention for adolescent OCD, a significant market, with a high probability of informing future treatment guidelines if successful. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will read a chapter and do exercises from a self-help book weekly for 12 weeks, alongside their current medication. 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.
Related Conditions
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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.