Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2014-10-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
5 Years
17 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Rachel Marsh
Irving Philips Professor of Medical Psychology (in Child Psychology)
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
Countries
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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7006
Identifier Type: -
Identifier Source: org_study_id
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