RecruitingNot ApplicableNCT05609916

CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD


Sponsor

Baylor College of Medicine

Enrollment

200 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.


Eligibility

Min Age: 7 YearsMax Age: 17 Years

Inclusion Criteria4

  • The child is between the ages of 7 to 17 at enrollment with a primary diagnosis of OCD of \> 6 months duration based on the Kiddie Schedule for Affective Disorders and Schizophrenia Lifetime Version for DSM-5 (KSADS-PL) and have a CY-BOCS ≥ 16.
  • 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.
  • Both the child and parent participating in the study are English speaking.
  • Both the child and their parent participating in the study reside in Texas.

Exclusion Criteria4

  • The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
  • The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
  • The child is receiving concurrent psychotherapy for OCD.
  • Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.

Interventions

BEHAVIORALCognitive Behavioral Therapy

During Phase I, participants will receive open label (no blinding) CBT during their study participation for 12 to 18 weeks. During Phase II, participants will continue receiving CBT maintenance sessions every two weeks for the first 4 weeks, followed by sessions every four weeks. They will also meet with the study physician every 2 weeks via telepsychiatry appointments for clinical and scalar assessment.


Locations(1)

Baylor College of Medicine

Houston, Texas, United States

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NCT05609916


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