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

NCT06942494 | Recruiting DMC

• 1 other identifier: 2024-112
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Obsessive - Compulsive Disorder

Keywords

Obsessive - Compulsive Disorder; Adolescents; Bibliotherapy

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)

Secondary Outcomes (5)

• 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)

• 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)

• 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)

• Clinical Global Impression - Improvement (CGI-I)

  Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)

• Clinical Global Impression - Severity (CGI-S)

  Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)

Other Outcomes (14)

• Change in Family Accommodation Scale - Self-Rated Version (FAS-SR) Total Score

  Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)

• Change in Children's Obsessive-Compulsive Impact Scale - Revised (COIS-R) Total Score

  Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)

• Change in Parenting Stress Index - Short Form (PSI-SF) Total Score

  Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)

Study Arms (2)

Family-Based Self-Help Intervention Group

EXPERIMENTAL

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.

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

Treatment-As-Usual Waitlist Control Group

ACTIVE COMPARATOR

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.

Drug: conventional medical treatment (TAU)

Interventions

conventional medical treatment (TAU) DRUG

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.

Treatment-As-Usual Waitlist Control Group

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

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.

Family-Based Self-Help Intervention Group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 10 and 17 years
• Satisfied with the diagnostic criteria for OCD in DSM-5
• ≤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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Xuhui, Shanghai Municipality, 20030, China

RECRUITING

MeSH Terms

Conditions

Compulsive Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Qing Fan, Doctor

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Yiwen Wu

CONTACT

+86 135 8590 0231; wuyiwenhsd@163.com

Xingyu Liu

CONTACT

+86 134 5319 0989; xingyu_liu@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 24, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-04

Locations

CN (1)