Overlapping Neural Circuits in Pediatric OCD

NCT02421315 | Completed Results

• 2 other identifiers: 7006R21MH101441
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the brain functioning of children and adolescent with OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.

Conditions

Obsessive Compulsive Disorder

Keywords

OCD; Functional Magnetic Resonance Imaging (fMRI); Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• Brain Activation Associated With the Resolution of Cognitive Conflict

  Task-based functional magnetic resonance imaging (fMRI) will be acquired from children and adolescents diagnosed with OCD and healthy comparison subjects (HCs) during their performance of a Simon Spatial Compatibility Task. In each trial, participants are presented with a leftward or rightward pointing arrow that is either congruent or incongruent with their position (left or right) on the screen. Participants are instructed to respond as quickly and accurately as possible to the direction in which the arrow was pointing by pressing a button on a response box using the index finger for left and the middle finger for right. Brain activation during the resolution of cognitive conflict is computed by contrasting blood-oxygen-level-dependent (BOLD) signal during Incongruent versus Congruent trials. BOLD signal is expressed in arbitrary units (A.U.s).

  single time point: baseline

Secondary Outcomes (3)

• Functional Connectivity

  single time point: Baseline

• Brain Gray Matter Thickness

  Single time point: Baseline

• Structural Connectivity (Streamline Counts)

  Single time point (baseline)

Study Arms (2)

Participants With Obsessive-compulsive Disorder (OCD)

EXPERIMENTAL

Children and adolescents who meet DSM-IV diagnostic criteria for OCD and had clinically significant obsessive-compulsive symptoms (CY-BOCS score\>15). Comorbid anxiety disorders, but no other lifetime psychiatric diagnoses, were permitted in the OCD group as long as OCD was the primary diagnosis. Participants were unmedicated and had not received a full course of CBT with exposure and response prevention for OCD prior to their participation in the study. Following baseline assessment and scan, patients with OCD underwent a course of manualized treatment of CBT with E/RP adapted for pediatric OCD delivered by a licensed clinical psychologist or advanced supervised graduate student in clinical psychology at the NYSPI.

Behavioral: CBT treatment for OCD based on Exposure & Response Prevention (EX/RP) and when indicated medication treatment

Healthy Control (HC) Participants

NO INTERVENTION

Healthy control (HC) participants matched on age and sex with the OCD group. HC participants had no lifetime psychiatric disorders. HC participants were assessed and scanned at baseline and again after 12-16 weeks.

Interventions

CBT treatment for OCD based on Exposure & Response Prevention (EX/RP) and when indicated medication treatment BEHAVIORAL

CBT treatment consisted of 12-16 hour-long sessions. For exceptional cases not showing clinical improvement after six CBT treatment sessions, complementary pharmacological treatment (SSRI) was offered as part of our treatment protocol. CBT for OCD involves gradually exposing patients to anxiety provoking stimuli while having patients refrain from engaging in compulsive rituals and/or avoidance behaviors. There are three major components of CBT treatment for OCD, specifically: (1) exposure to anxiety provoking stimuli, (2) response prevention, and (3) cognitive techniques intended to decrease anxiety during the exposure and response prevention processes.

Participants With Obsessive-compulsive Disorder (OCD)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants must be 5-17 at the time of consent
• Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Diagnosis of OCD as the principal problem
• Not on psychotropic medication and not receiving current psychotherapy for OCD
• Written informed assent by the participants (8 and older) and consent by the parent
• Participants and a parent/guardian must be able to read and understand English

You may not qualify if:

• DSM-IV current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
• DSM-IV lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
• Active suicidal ideation
• Females who are pregnant or nursing
• Major medical or neurological problems
• Presence of metallic device or dental braces
• IQ\<80
• A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
• Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
• Individuals who have received a full course of CBT in the past
• A positive pregnancy test
• Positive urine screen for illicit drugs
• Inability of participant or parent/guardian to read or understand English
• Participants must be 5-17 at the time of consent
• Written informed assent by the participants (8 and older) and consent by the parent

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

NY State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (4)

• Wang Z, Fontaine M, Cyr M, Rynn MA, Simpson HB, Marsh R, Pagliaccio D. Subcortical shape in pediatric and adult obsessive-compulsive disorder. Depress Anxiety. 2022 Jun;39(6):504-514. doi: 10.1002/da.23261. Epub 2022 Apr 29.

  PMID: 35485920 DERIVED

• Lv D, Ou Y, Wang Y, Ma J, Zhan C, Yang R, Chen Y, Shang T, Jia C, Sun L, Zhang G, Sun Z, Li J, Wang X, Guo W, Li P. Altered Functional Connectivity Strength at Rest in Medication-Free Obsessive-Compulsive Disorder. Neural Plast. 2021 Sep 8;2021:3741104. doi: 10.1155/2021/3741104. eCollection 2021.

  PMID: 34539777 DERIVED

• Cyr M, Pagliaccio D, Yanes-Lukin P, Fontaine M, Rynn MA, Marsh R. Altered network connectivity predicts response to cognitive-behavioral therapy in pediatric obsessive-compulsive disorder. Neuropsychopharmacology. 2020 Jun;45(7):1232-1240. doi: 10.1038/s41386-020-0613-3. Epub 2020 Jan 17.

  PMID: 31952071 DERIVED

• Pagliaccio D, Cha J, He X, Cyr M, Yanes-Lukin P, Goldberg P, Fontaine M, Rynn MA, Marsh R. Structural neural markers of response to cognitive behavioral therapy in pediatric obsessive-compulsive disorder. J Child Psychol Psychiatry. 2020 Dec;61(12):1299-1308. doi: 10.1111/jcpp.13191. Epub 2019 Dec 31.

  PMID: 31889307 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Rachel Marsh
• Organization: New York State Psychiatric Institute

rachel.marsh@nyspi.columbia.edu

646-774-5774

Study Officials

• Rachel Marsh, Ph.D.

  New York Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Irving Philips Professor of Medical Psychology (in Child Psychology)

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 20, 2015
• Study Start: October 1, 2014
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)