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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06407648
Other study ID # IRB00406231
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 3, 2024
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source Johns Hopkins University
Contact Alexandra Chang
Phone 443-300-8836
Email coach@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents. The investigators will also examine whether personalized cognitive-behavioral therapy (CBT) that is informed by personalized OCD assessments yields better clinical outcomes when compared to standard CBT for youth with OCD


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria: 1. be 8-17 years of age; 2. meet diagnostic criteria for a primary diagnosis of OCD on a structured clinical interview; 3. have moderate OCD severity as evidenced by a CY-BOCS total score of =16; 4. medication free and/or on a stable dose of medication 8 weeks prior to study participation; 5. be English speaking. Exclusion Criteria: 1. the presence of psychotic disorder, bipolar disorder, or autism spectrum disorders; 2. significant suicidal ideation that warrants medical intervention; 3. concurrent psychotherapy for OCD; 4. inability to complete scales, or attend visits.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Personalized Assessments
Personalized CBT will use individualized OCD symptom networks to guide CBT strategies to target central symptom nodes in contemporaneous networks.
Standard of Care
The standard CBT condition will use standard-of-care approaches to guide CBT strategies to target OCD symptoms.

Locations

Country Name City State
United States Johns Hopkins University School of Medicine Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score A clinician-rated measure of OCD symptom severity in the past week. This 10-item measure is rated on a 0 to 5 scale with a total score ranging from 0 to 50. A higher total score is reflective of greater OCD symptom severity. Screen, Baseline (Week 0), Week 4, Week 8, and Week 12
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