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

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Obsessive - Compulsive Disorder

Treatments: Drug: conventional medical treatment (TAU); Behavioral: Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder

Study type: Interventional

Funder types: Other

Identifiers

NCT06942494

2024-112

Details and patient eligibility

About

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

Enrollment: 88 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Family-Based Self-Help Intervention Group

Experimental group

Description:

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.

Treatment:

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

Treatment-As-Usual Waitlist Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: conventional medical treatment (TAU)