Actively Recruiting
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Led by Baylor College of Medicine · Updated on 2025-07-20
200
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether children and adolescents aged 7 to 17 with obsessive-compulsive disorder (OCD) who improve with cognitive-behavioral therapy (CBT) added to serotonin reuptake inhibitor (SRI) medication can successfully stop their medication without relapsing over a 24-week period. OCD is a chronic psychiatric condition, and while SRIs help some youth, adding CBT may improve outcomes. The study also plans to collect genetic samples to explore future risk factors. The study has two phases. In Phase I, all participants receive web-based CBT for 12 to 18 weeks. Those who reach wellness criteria based on symptom reduction will proceed to Phase II, where they are randomly assigned to either continue their SRI medication or gradually switch to a placebo. During Phase II, participants continue CBT maintenance sessions and attend medication visits for 24 weeks. A follow-up assessment occurs 12 months after Phase II ends. Participants will engage in therapy sessions, medication visits, and assessments including the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) to measure symptom changes. Clinical evaluations and questionnaires will be conducted via telepsychiatry every two weeks initially, then monthly. Researchers will monitor symptom stability, relapse, and overall improvement throughout the study and follow-up, supporting careful tracking of medication discontinuation effects over time.
CONDITIONS
Brief Title
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is between 7 and 17 years old at enrollment
- Primary diagnosis of OCD lasting more than 6 months with a CY-BOCS score of 16 or higher
- Currently on a stable, maximally tolerated SRI medication (excluding paroxetine) for at least 12 weeks
- Both child and parent are English speaking
- Both child and parent reside in Texas
You will not qualify if you...
- Diagnosis of lifetime bipolar disorder, psychotic disorder, or intellectual disability
- Severe suicidal or homicidal thoughts or self-injury requiring medical intervention
- Currently receiving psychotherapy for OCD
- Started a psychotropic medication less than 4 weeks before enrollment or stimulant/psychoactive medication less than 2 weeks before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 to 18 weeks
Participants receive web-based cognitive-behavioral therapy (CBT) for 12 to 18 weeks to assess treatment response.
Duration - 24 weeks
Participants who benefit from CBT are randomized to either continue their SRI medication or undergo medication discontinuation with placebo substitution. They continue CBT maintenance sessions and medication visits via telepsychiatry.
Telepsychiatry medication visits every 2 weeks; CBT maintenance sessions every 2 weeks for the first 4 weeks, then every 4 weeks
Duration - 12 months after treatment phase
Participants complete a follow-up assessment 12 months after the end of the treatment phase to evaluate long-term outcomes.
1 follow-up assessment visit
Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eric A Storch, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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