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

Official title

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

Overview

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

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 outcome measures

• Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score [Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)]

Secondary outcome measures (5)

• Change in Children's Depression Inventory (CDI) Total Score [Time frame: 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 [Time frame: 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 [Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)]
• Clinical Global Impression - Improvement (CGI-I) [Time frame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)]
• Clinical Global Impression - Severity (CGI-S) [Time frame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)]

Eligibility criteria

Inclusion criteria

• Age between 10 and 17 years
• Satisfied with the diagnostic criteria for OCD in DSM-5
• 16≤CY-BOCS score ≤23
• Taking medication stably for 6 weeks
• Education level ⩾6 years
• At least one parent can accompany the patients throughout the entire intervention process
• The patient and the participating parent have sufficient reading and writing skills to complete the treatment intervention
• 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

• Obsessive-compulsive symptoms were too severe to participate in the experiment(CY-BOCS score ≥24)
• High risk of suicide
• 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
• Completed a Cognitive Behavioral Therapy (CBT) course for OCD within the past 12 months.
• An IQ lower than 80
• Currently undergoing other psychological/physical treatments
• Uncooperative or unable to complete treatment
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Mental Health Center — Xuhui

Identifiers

NCT: NCT06942494 · 2024-112

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗