Recruiting

CBT Augmentation

Sponsor:

Baylor College of Medicine

Code:

NCT05609916

Conditions

Cognitive Behavioral Therapy

Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder in Children

Obsessive-Compulsive Disorder in Adolescence

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy

Study Details

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.

Conditions

Cognitive Behavioral Therapy

Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder in Children

Obsessive-Compulsive Disorder in Adolescence

Study ID

NCT05609916

Start date

Nov 30, 2022

Status verified date

Aug, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Continued SRI

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.

placebo comparator: Discontinuation titration to placebo

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.

other: Open label CBT

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.

Interventions

Cognitive 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.

Primary outcome measure

  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Eric A Storch, Ph.D.

713-798-3080eric.storch@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Alyssa Hertz

alyssa.hertz@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-08-04.