CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Not Applicable

Recruiting

• Conditions: Cognitive Behavioral Therapy; Obsessive-Compulsive Disorder; Obsessive-Compulsive Disorder in Children; Obsessive-Compulsive Disorder in Adolescence
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT05609916
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed Description

Pediatric obsessive-compulsive disorder (OCD) is a common, chronic, and severe psychiatric disorder. Currently, many youth with OCD are treated with medication, such as a serotonin reuptake inhibitor (SRI); however, only a subset of them responds to SRI. Data show that the addition of cognitive-behavioral therapy (CBT) to SRI partial responders is effective although extended SRI use with CBT can attenuate combined treatment outcomes. This placebo-controlled study will enroll pediatric OCD patients to examine if those who benefit from CBT augmentation can discontinue their SRI successfully without relapse over 24-weeks. This study will also bank genomic samples for future analysis when polygenic risk scores for OCD may become available.

This study will be conducted in two phases. In Phase I, all participants will receive a web-based CBT for 12 to 18 weeks. At the end of Phase I, those who achieve wellness indicated by CY-BOCS ≤ 12 and ≥ 50% reduction since baseline for 3 consecutive weeks, will go on to the next phase. In Phase II, participants will be randomized into two groups: 1) Continued SRI and 2) Discontinuation titration to placebo. In this phase, all participants will receive web-based CBT maintenance sessions and attend medication visits for 24 weeks. At 12 months after the end of Phase II, all participants will complete a follow-up assessment.

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Study Start: 2022-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-12-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continued SRI	Cognitive Behavioral Therapy	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.
Discontinuation titration to placebo	Cognitive Behavioral Therapy	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.
Open label CBT	Cognitive Behavioral Therapy	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.

Primary Outcome Measures

Name	Time	Method
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	7 days	Clinician-rated child OCD symptoms and severity throughout the past week. The scale has a checklist of obsessions and compulsions, followed by severity items each scored on a 0 to 4 scale.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Improvement	7 days	Clinician-rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved).

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States