Precision Analytic Research Methods in OCD

Mount Sinai Health System

Status: Enrolling

Conditions: Obsessive Compulsive Disorder

Treatments: Behavioral: Exposure and Response Prevention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07011901

STUDY-24-01125

K23MH133997 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Psychiatric disorders characterized by compulsivity, such as obsessive-compulsive disorder (OCD), result in considerable functional impairment and many individuals do not respond to gold-standard treatments. Compulsivity has long been thought to occur due to exaggerated habits and reduced goal-directed control, although more recently, this conceptualization of compulsivity as an imbalance of two cognitive systems has been challenged as overly narrow. This study will recruit 100 individuals (50 adults diagnosed with OCD, 50 healthy controls) and leverage the measurement precision offered by theory-driven computational modeling in combination with electroencephalogram (EEG) to go beyond this binary theory of compulsivity, revealing how more complex interactions of neurocognitive subcomponents contribute to compulsivity-information that could ultimately lead to improved treatment personalization and clinical outcomes.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Participants must be:

• between the ages 18-55 years old
• English-speaking
• right-handed
• able to provide consent

Exclusion criteria

Individuals diagnosed with OCD will be excluded if:

• they meet diagnostic criteria for certain other psychiatric disorders
• are taking psychiatric medication or have received behavioral treatment for OCD within a certain timeframe
• if it is unsafe for them to participate in research

Healthy control participants will be excluded if:

• they have a current psychiatric disorder
• a lifetime history of certain psychiatric disorders
• are taking psychiatric medication or have in the past
• have a parent or sibling who has been diagnosed with OCD
• if it is unsafe for them to participate in research

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Participants diagnosed with OCD

Experimental group

Description:

All participants diagnosed with Obsessive Compulsive Disorder (OCD) who enroll in this study will receive 17 sessions of exposure and response prevention, a specialized cognitive behavioral therapy for OCD, over the course of 10 weeks.

Treatment:

Behavioral: Exposure and Response Prevention

Healthy controls

No Intervention group

Description:

Individuals who do not have a current or lifetime psychiatric diagnosis will not receive any treatment.