RECRUITINGINTERVENTIONAL

Effect of a Family-Based CBT Self-Help Intervention for Adolescents With OCD

Effect of a Family-Based Cognitive Behavioral Therapy Self-Help Intervention for Adolescents With Obsessive-Compulsive Disorder：A Randomized Controlled Trial

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

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 tolerated by the patients.

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 the therapist via WeChat to ask questions and upload records of their completed exercises. The therapist will respond to any questions within 48 hours by sending written messages via WeChat, with each family receiving no more than 30 minutes of such written guidance per week. All therapists will be required to keep a weekly log of the time spent providing guidance to each participating family.If a participating family does not initiate contact, the therapist will not provide proactive guidance.

Locations (1)

Shanghai Mental Health Center

Xuhui, Shanghai Municipality, China