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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
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.
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.
Shanghai Mental Health Center
Xuhui, Shanghai Municipality, China
RECRUITINGChange in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score
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.
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Change in Children's Depression Inventory (CDI) Total Score
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.
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
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.
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
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.
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)
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).
Time frame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Clinical Global Impression - Severity (CGI-S)
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).
Time frame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
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