Clinical trial NCT06942494: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obsessive - Compulsive Disorder
Keywords: Obsessive - Compulsive Disorder
Adolescents
Bibliotherapy
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 88
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Secondary outcomes:
measure: Change in Children's Depression Inventory (CDI) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Change in Obsessive-Compulsive Inventory - Child Version (OCI-CV) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Other outcomes:
measure: Change in Family Accommodation Scale - Self-Rated Version (FAS-SR) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Change in Children's Obsessive-Compulsive Impact Scale - Revised (COIS-R) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Change in Parenting Stress Index - Short Form (PSI-SF) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Change in Family Quality of Life Questionnaire (FAMQOL) Total Score
timeFrame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
measure: Cost-effectiveness analysis
timeFrame: From Baseline to Week 12(post-treatment)
measure: Dropout rate
timeFrame: From Baseline to Week 12(post-treatment)
measure: Homework completion
timeFrame: From Baseline to Week 12(post-treatment)
measure: Subjective satisfaction with treatment
timeFrame: From Baseline to Week 12(post-treatment)
measure: Treatment safety
timeFrame: From Baseline to Week 12(post-treatment)
measure: The University of Rhode Island Change Assessment(URICA)
timeFrame: Change from Baseline at Week12(post-treatment)
measure: Short-Form 6-Dimension Health Survey Version 2 (SF-6Dv2)
timeFrame: From Baseline to Week 12(post-treatment)
measure: Cost-utility analysis
timeFrame: From Baseline to Week 12(post-treatment)
measure: Change in Neuroelectrophysiological Indicators
timeFrame: Drug-free phase（before baseline and prior to starting medication）, Baseline at enrollment(Week 0), Post-Treatment(Week 12)
measure: Change in Neuroimaging Indicators
timeFrame: Drug-free phase（before baseline and prior to starting medication）, Baseline at enrollment(Week 0), Post-Treatment(Week 12)
Locations:
Study officials:
affiliation: Shanghai Mental Health Center
name: Qing Fan, Doctor
role: STUDY_CHAIR
References: