Actively Recruiting

Phase Not Applicable
Age: 10Years - 17Years
All Genders
Healthy Volunteers
ID06942494

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

Led by Shanghai Mental Health Center · Updated on 2025-07-30

88

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying if a self-help book, combined with medication, can help reduce obsessive-compulsive disorder (OCD) symptoms in adolescents aged 10 to 17. The trial aims to find out whether this combination improves symptom severity better than medication alone and to identify which adolescents benefit most from the self-help approach. It is a randomized controlled trial led by Shanghai Mental Health Center focusing on family-based cognitive behavioral therapy (CBT) intervention. Participants will be randomly assigned to one of two groups. One group will continue stable medication and follow a 12-week CBT-based self-help book designed for Chinese adolescents, involving family participation. They will read one chapter weekly and complete exercises, with therapist support via WeChat messages. After this, a 3-month follow-up phase will collect data on symptom maintenance and treatment adherence without new therapies. The control group will continue medication alone for 12 weeks, then receive access to the self-help book as delayed intervention. Throughout the study, participants will attend clinic visits before and after the intervention to check symptoms and perform assessments. Researchers will measure changes in OCD severity using the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and other related scales at multiple points including post-intervention and follow-ups at 1 and 3 months. The study also tracks depression, anxiety, and clinical global impressions to monitor progress and safety over the course of about six months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 10 and 17 years
  • Diagnosis of obsessive-compulsive disorder (OCD) according to DSM-5
  • Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score between 16 and 23
  • Stable medication use for at least 6 weeks
  • Education level of 6 years or more
  • At least one parent available to support throughout the intervention
  • Both patient and parent have sufficient reading and writing skills
  • Both patient and parent have adequate hearing and vision to complete study examinations
  • Right-handed (for participants undergoing fMRI only)
  • Informed consent signed by participant and guardian
Not Eligible

You will not qualify if you...

  • CY-BOCS score 24 or higher (too severe symptoms)
  • High risk of suicide
  • Comorbid brain organic diseases, severe physical illnesses, learning disabilities, autism spectrum disorder, schizophrenia spectrum or other psychotic disorders, bipolar disorder, severe eating disorders, or substance abuse
  • Completed cognitive behavioral therapy (CBT) for OCD within the past 12 months
  • IQ lower than 80
  • Currently receiving other psychological or physical treatments
  • Uncooperative or unable to complete treatment
  • Metal implants in the body (for participants undergoing fMRI only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive either a 12-week family-based cognitive behavioral therapy (CBT) self-help intervention alongside stable medication or continue their stable medication without psychological intervention.

Weekly contact via WeChat with therapist available for up to 30 minutes per week for questions and guidance; medication continues as usual

Follow-up

Duration - 3 months

Participants are monitored for symptom maintenance and treatment adherence for 3 months after the intervention with no new therapeutic components introduced.

3 follow-up visits at Week 16 (1 month post-intervention) and Week 24 (3 months post-intervention)

Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Xuhui, Shanghai Municipality, China, 20030

Actively Recruiting

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Research Team

Y

Yiwen Wu

X

Xingyu Liu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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