Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-24

Study Completion Date

2023-06-03

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Obsessive-compulsive Disorders and Symptoms in Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Children ages 6-14 with OCD, obsessive compulsive symptoms, or healthy controls

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Obsessive Compulsive Disorder

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type 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.

Subclinical Obsessive-Compulsive symptoms (OCS)

Group Type OTHER

Community Referral as appropriate

Intervention Type OTHER

Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment

Healthy Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy

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.

Intervention Type BEHAVIORAL

Community Referral as appropriate

Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnosis of OCD as the principal problem
2. Not on psychotropic medication and not receiving current psychotherapy for OCD
3. Written informed assent by the participants and consent by the parent
4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION

1. DSM-5 current diagnosis of major depressive disorder, or substance/alcohol abuse
2. DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
3. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications (stable doses of stimulants or other types of ADHD medications - e.g. Guanfacine - are allowable for OCD subjects with comorbid attention deficit hyperactivity disorder following investigator review of medication; on day of study scan, subjects must be willing to refrain from taking medication until after scan is completed)
4. Active suicidal ideation
5. Females who are pregnant or nursing
6. Major medical or neurological problems
7. Presence of metallic device or dental braces
8. Intelligence Quotient (IQ)\<80
9. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
10. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
11. Individuals who have received a full course of CBT in the past
12. A positive pregnancy test
13. Positive urine screen for illicit drugs

Healthy controls

INCLUSION:

1. Written informed assent by the participants and consent by the parent
2. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

1. Any current or lifetime psychiatric diagnosis
2. Active suicidal ideation
3. Females who are pregnant or nursing
4. Major medical or neurological problems
5. Presence of metallic device or dental braces
6. IQ \<80
7. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
8. A positive pregnancy test
9. Positive urine screen for illicit drugs

Obsessive Compulsive Symptoms

INCLUSION:

1. Presence of obsession(s) and/or compulsion(s) but no current diagnosis of OCD (i.e.,\<1 hour/day, no more than mild interference or distress)
2. Not on psychotropic medication and not receiving current psychotherapy for OCD
3. Written informed assent by the participants and consent by the parent
4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

1. DSM-5 current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
2. DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
3. Active suicidal ideation
4. Females who are pregnant or nursing
5. Major medical or neurological problems
6. Presence of metallic device or dental braces
7. IQ\<80
8. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
9. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
10. Individuals who have received a full course of CBT in the past
11. Positive urine screen for illicit drugs

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes