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

NCT ID: NCT06942494

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-12-31

Brief 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

Conditions

Obsessive - Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Family-Based Self-Help Intervention Group

Adolescents with OCD in this group will continue their stable pharmacological treatment for at least six weeks prior to enrollment. After baseline assessment, they will receive a 12-week structured cognitive behavioral therapy (CBT)-based self-help intervention, specifically designed for chinese adolescents and involving family participation. After the 12-week intervention, participants will enter a 3-month follow-up phase, during which no new therapeutic components will be introduced, but data on symptom maintenance and treatment adherence will be collected.During the 12-week intervention they will continue with the medications they already have.

Group Type: EXPERIMENTAL

Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder

Intervention Type: BEHAVIORAL

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.

Treatment-As-Usual Waitlist Control Group

Adolescents with OCD in this group will be similarly required to receive at least six weeks of stabilizing medication prior to enrollment. In this group, participants will be treated as usual. Namely, they will continue with the medications they already have with no changes throughout the 12-week intervention period. No psychological intervention will be provided during this phase. After completing the follow-up assessment at week 12, participants will be offered access to the CBT-based self-help book as a delayed intervention.

Group Type: ACTIVE_COMPARATOR

conventional medical treatment (TAU)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Fan, Doctor

Role: STUDY_CHAIR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Xuhui, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yiwen Wu

Role: CONTACT

wuyiwenhsd@163.com

+86 135 8590 0231

Xingyu Liu

Role: CONTACT

xingyu_liu@sjtu.edu.cn

+86 134 5319 0989

Facility Contacts

Qing Fan, Doctor

Role: primary

fanqing_98@vip.sina.com

+86 13916436072

Other Identifiers

2024-112

Identifier Type: -

Identifier Source: org_study_id