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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06942494
• Lead Sponsor: Shanghai Mental Health Center

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Primary Completion: 2027-08
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment-As-Usual Waitlist Control Group	conventional medical treatment (TAU)	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.
Family-Based Self-Help Intervention Group	Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder	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.

Primary Outcome Measures

Name	Time	Method
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score	Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)	The CY-BOCS is a clinician-rated instrument used to assess the severity of obsessive-compulsive symptoms in children and adolescents, which has good reliability and validity.. The total score ranges from 0 to 40, with higher scores indicating greater severity. The primary outcome is the change in CY-BOCS total score from baseline to each follow-up point.

Secondary Outcome Measures

Name	Time	Method
Change in Children's Depression Inventory (CDI) Total Score	Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)	The CDI is currently one of the most widely used self-assessment tools for evaluating depressive symptoms in children and adolescents. The scale consists of 27 multiple-choice items that assess a range of common depressive symptoms in youth, including sadness, hopelessness, suicidal ideation, and disturbances in sleep and appetite. Each item offers three response options reflecting increasing levels of symptom severity, scored as 0, 1, or 2.Scores range from 0 to 54, with higher scores indicating more severe depressive symptoms.The Chinese version used in the current study has demonstrated good psychometric properties, including a Cronbach's alpha of 0.85, a split-half reliability coefficient of 0.71, and a test-retest reliability coefficient of 0.75.
Change in Obsessive-Compulsive Inventory - Child Version (OCI-CV) Total Score	Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)	The Obsessive-Compulsive Inventory-Child Version (OCI-CV) is a multidimensional self-report scale developed by Foa and colleagues to assess the severity of obsessive-compulsive symptoms in children and adolescents aged 7 to 17. The scale consists of 21 items covering six symptom dimensions: Doubting/Checking, Obsessing, Hoarding, Washing, Ordering, and Neutralizing. Each item is rated on a 3-point Likert scale: 0 = Never, 1 = Sometimes, 2 = Always. The Chinese version of the scale used in current study has demonstrated strong psychometric properties and has been validated in international clinical samples. The internal consistency of the total scale was 0.856, and the internal consistency coefficients for the subscales ranged from 0.462 to 0.747. Test-retest reliability coefficients ranged from 0.532 to 0.758.The outcome is measured by the change in total score from baseline.
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score	Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)	The Screen for Child Anxiety Related Emotional Disorders (SCARED) is a self-report screening tool developed to assess anxiety symptoms in children and adolescents aged 9 to 18. It is widely used in clinical settings, research, and epidemiological studies as a supplemental tool for the diagnosis of anxiety-related disorders. The SCARED scale assesses five factors: somatization, generalized anxiety, separation anxiety, social phobia, and school phobia. Items are rated on a 3-point Likert scale: 0 = not true or hardly ever true, 1 = somewhat true or sometimes true, and 2 = very true or often true.; The psychometric properties of the Chinese version used in the present study include test-retest reliability coefficients ranging from 0.567 to 0.608, split-half reliability of 0.88, and Cronbach's alpha coefficients ranging from 0.43 to 0.89. Item-total correlations ranged from 0.43 to 0.74.
Clinical Global Impression - Improvement (CGI-I)	Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)	The Clinical Global Impression (CGI) scale is a clinician-rated tool commonly used in psychiatric treatment studies to subjectively assess the severity of illness, treatment response, and overall therapeutic efficacy. It was developed by the Early Clinical Drug Evaluation Program (ECDEU) research group for clinical trials sponsored by the National Institute of Mental Health (NIMH). The CGI provides a clinician-based evaluation framework for determining the severity of a patient's symptoms and monitoring treatment progress over time. The CGI-I is used to assess overall improvement relative to baseline, scored from 1 (very much improved) to 7 (very much worse).
Clinical Global Impression - Severity (CGI-S)	Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)	The CGI-S is a clinician-rated measure of the severity of the patient's illness, scored from 1 (normal) to 7 (among the most extremely ill).