Overlapping Neural Circuits in Pediatric OCD

NCT ID: NCT02421315

Last Updated: 2023-08-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive control) and the capacity to anticipate, respond to, and learn from reward (reward processing) are key processes for human behavior. Dysfunction in these processes has been hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. The investigators will use multimodal imaging to investigate neural circuits that support cognitive control and reward processing, using pediatric OCD as a model system. The short-term goal is to clarify how circuit-based abnormalities contribute to repetitive thoughts/behaviors; these data will inform future trans-diagnostic studies. The long-term goal is to identify control and reward circuit-abnormalities as targets for new trans-diagnostic treatments.

Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Participants With Obsessive-compulsive Disorder (OCD)

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Healthy Control (HC) Participants

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* Participants must be 5-17 at the time of consent
* 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

Exclusion Criteria

* 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


* Any current or lifetime psychiatric diagnosis
* 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)
* A positive pregnancy test
* Positive urine screen for illicit drugs
* Inability of participant or parent/guardian to read or understand English
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Rachel Marsh

Irving Philips Professor of Medical Psychology (in Child Psychology)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Marsh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York Psychiatric Institute

Locations

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NY State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35485920 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34539777 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31952071 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31889307 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R21MH101441

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7006

Identifier Type: -

Identifier Source: org_study_id

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