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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH114958-01A1 | U.S. NIH Grant/Contract | View source | |
| R01MH115024-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Columbia University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This study will use magnetic resonance imaging (MRI) to assess the function and structure of overlapping task control circuits in children with a range of Obsessive-Compulsive symptoms (OCS). The functioning of task control circuits will be assessed using the well-validated Multisource interference task (MSIT). This study will also assess functional and anatomical connectivity within task control circuits in the same children, and determine whether disturbances in these overlapping circuits are associated with Obsessive-Compulsive Disorder (OCD) symptom severity. Behavioral measures will be administered to further assess regulatory, learning and memory functions. Children with OCD will then be offered a standard course of up to 12 cognitive behavioral therapy (CBT), either via remote video conference sessions or in person visits when clinically indicated, before scanning (along with age-and gender-matched control participants) in order to assess how these circuits may change with treatment. Children with subclinical OC symptoms will be offered referral for treatment on an as-needed basis. In addition, de-identified data may be used in the future to conduct secondary data analyses. As more about OC symptoms and neurobiological mechanisms of interest in the current study are understood, data may be used to answer questions beyond those described in this protocol. All study procedures will be conducted on-site at Columbia University/the New York State Psychiatric Institute (New York, NY) and the University of Michigan's outpatient Child and Adolescent Psychiatry (Ann Arbor, Michigan).
Recruitment is complete. U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume analysis of results from its two sites for results reporting after OHRP and the IRB has approved the resumption of research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obsessive Compulsive Disorder | Experimental |
| |
| Subclinical Obsessive-Compulsive symptoms (OCS) | Other |
| |
| Healthy Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | The treatment team will offer a course of up to 12 cognitive behavioral therapy (CBT) (45 minute sessions for 12 to 16 weeks), augmented by medication treatment when clinically indicated based on the clinical treatment standards. Due to Covid, therapy sessions are offered via remote video conference (in clinic sessions made available if clinically indicated). Cognitive-behavioral therapy (CBT) is a treatment based on learning and cognitive theories. CBT for Obsessive-Compulsive Disorder (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task | up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits | up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 10 minutes | |
| Child Yale-Brown Obsessive Compulsive Scale | Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) is scored on a scale of 0 to 40, with 40 being the most severe. |
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Obsessive-Compulsive Disorder (OCD) patient group
INCLUSION:
EXCLUSION
Healthy controls
INCLUSION:
EXCLUSION:
Obsessive Compulsive Symptoms
INCLUSION:
EXCLUSION:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| New York State Psychiatric Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35485920 | Derived | 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. |
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Participant data will be shared between sites at the University of Michigan and Columbia. A DUA will also be established per University guidelines as required. Coded, de-identified IPD will be shared with the NIMH data repository, RDoCdb.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2023 | Aug 11, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Children ages 6-14 with OCD, obsessive compulsive symptoms, or healthy controls
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| Community Referral as appropriate | Other | Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment |
|
| up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour |
| Obsessive Compulsive Inventory - Child Version (OCI-CV) | Self-report assessment of obsessive compulsive symptoms, non-clinical to clinical range. | baseline assessment of all participants (OCD, subclinical OCS and HC) |
| New York |
| New York |
| 10032 |
| United States |