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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

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.

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

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

irritability

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,012 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

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 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

Recent research and studies

clinicaltrials.govStudy

CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Eric A Storch 2022. "CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05609916.

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