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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
The child is on stable and maximally tolerated SRI medication (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, citalopram, escitalopram) for ≥12 weeks given that they are persistently and moderately symptomatic. Paroxetine is exclusionary due to safety concerns.
Be younger than 18 years old
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up7 days
Awards & highlights

Study 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.

Eligible Conditions
  • Obsessive-Compulsive Disorder
  • Cognitive Behavioral Therapy

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Secondary outcome measures
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
982 Previous Clinical Trials
5,995,794 Total Patients Enrolled
14 Trials studying Obsessive-Compulsive Disorder
799 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this scientific investigation admitting elderly individuals?

"As indicated in the study's inclusion criteria, prospective patients should be between the ages of 7 to 17. There are 259 studies for participants aged below 18 and 668 for those above 65 years old."

Answered by AI

How many individuals have enrolled in the clinical trial thus far?

"Affirmative. Clinicaltrials.gov contains information that this clinical trial is currently soliciting patients, the initiation date being November 1st 2022 and most recently edited on November 2nd 2022. 200 individuals are sought from a single medical site for participation in this experiment."

Answered by AI

Who is eligible to participate in this clinical trial?

"This trial seeks out two-hundred children between the ages of 7 and 17 who are diagnosed with obsessive compulsive disorder (OCD). Essential criteria for enrolment include: a KSADS score indicating OCD diagnosis lasting more than 6 months, symptom severity indicated by CY-BOCS ≥20, stable and maximally tolerated Selective Serotonin Reuptake Inhibitor (SSRI) medication usage for at least 12 weeks, Wechsler Abbreviated Scale for Intelligence (WASI) IQ of 85 or higher , English fluency from both child and parent participants, Texas (OCD). Essential criteria for enrolment include: a KSADS score indicating OCD diagnosis lasting more than 6 months, symptom severity indicated by CY-BOCS ≥20, stable and maximally tolerated Selective Serotonin Reuptake Inhibitor (SSRI) medication usage for at least 12 weeks, Wechsler Abbreviated Scale for Intelligence (WASI) IQ of 85 or higher , English fluency from both child and parent participants, Texas residence from those same individuals, meeting all"

Answered by AI

Is it feasible to enrol in this experiment at present?

"Data on clinicaltrials.gov affirms that this research is seeking participants, with the original post being uploaded on November 1st 2022 and the last update occurring a day later."

Answered by AI
~120 spots leftby May 2025