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Behavioral Intervention

Cognitive Behavioral Therapy for Pediatric OCD

N/A
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Summary

This trial tests if teens with OCD can discontinue meds after getting extra help via CBT, and still stay symptom-free over 6 months.

Who is the study for?
This trial is for children aged 7-17 in Texas with a primary diagnosis of OCD lasting over 6 months, who are moderately symptomatic despite being on stable SRI medication for at least 12 weeks. Participants must speak English and not be taking certain excluded medications or have specific other mental health diagnoses.
What is being tested?
The study tests if Cognitive Behavioral Therapy (CBT) can help kids with OCD stop taking their Selective Serotonin Reuptake Inhibitor (SRI) meds without their symptoms coming back. The test lasts for half a year to see if the benefits last.
What are the potential side effects?
Since this trial focuses on CBT, which is a type of talk therapy, there aren't typical drug side effects. However, discussing distressing thoughts or feelings during therapy could potentially cause temporary discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Secondary study objectives
Clinical Global Impression-Improvement

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937
8%
irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
MESH

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Open label CBTExperimental Treatment1 Intervention
During Phase I, all participants will receive open label cognitive-behavioral therapy. Only those who achieve significant benefit will be able to most on to the post-phase I assessment, and then to the random assignment to Continued SRI or Discontinuation titration to placebo arms.
Group II: Continued SRIActive Control1 Intervention
After post-phase I assessment, participants who are eligible will be randomized to 1) Continued SRI. For these participants, the medication (SRI) will be provided at a consistent dosage.
Group III: Discontinuation titration to placeboPlacebo Group1 Intervention
After post-phase I assessment, participants who are eligible will be randomized to 2) Discontinuation titration to placebo. For these participants, the placebo substitution in an increasing proportion of capsules will be implemented until all drug is withdrawn.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,229 Total Patients Enrolled
14 Trials studying Obsessive-Compulsive Disorder
562 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

CBT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05609916 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Continued SRI, Discontinuation titration to placebo, Open label CBT
Obsessive-Compulsive Disorder Clinical Trial 2023: CBT Highlights & Side Effects. Trial Name: NCT05609916 — N/A
CBT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05609916 — N/A
~81 spots leftby Dec 2025
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