CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Cognitive Behavioral Therapy, Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder in Children
About this trial
This is an interventional treatment trial for Cognitive Behavioral Therapy
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Baylor College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
Other
Continued SRI
Discontinuation titration to placebo
Open label CBT
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.
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participants, the placebo substitution in an increasing proportion of capsules will be implemented until all drug is withdrawn.
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.