Neural Correlates of Compulsivity

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05195476

Collaborator

International OCD Foundation (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to collect data from individuals with OCD and healthy controls in order to clarify how learning strategies are employed differently by individuals with compulsive psychopathology and healthy individuals, and how these processes change over time and are related to treatment outcomes. Behavioral and EEG data will be collected during two experimental reinforcement learning tasks from participants diagnosed with OCD (n = 30) and healthy controls (n = 30). Computational modeling, an advanced data analytic approach that can directly link neural measures with behavior, will be used to quantify learning processes. These parameters then will be related to measures of neural events obtained using EEG, a neuroimaging method that has high temporal resolution, to test for evidence of neurocognitive alterations.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Behavioral: Exposure and Response Prevention (Ex/RP)	N/A

Detailed Description

This study will be conducted over the course of eight weeks. First, the participant will meet with the study psychologist to determine eligibility for the study. This includes an assessment of psychiatric and medical history. Eligible participants will then complete an in-person study session which includes completing questionnaires and playing computerized games while an electroencephalogram (EEG) is recorded. Participants will repeat these questionnaires and the EEG task battery eight weeks later. Individuals who have been diagnosed with OCD will receive exposure and response prevention (Ex/RP), the gold-standard behavioral treatment for OCD, during the eight week period.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants with OCD will receive exposure and response prevention (Ex/RP), the gold-standard behavioral treatment for OCD. Healthy controls will not receive treatment.Participants with OCD will receive exposure and response prevention (Ex/RP), the gold-standard behavioral treatment for OCD. Healthy controls will not receive treatment.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Neural Correlates of Compulsivity

Actual Study Start Date :

Dec 17, 2021

Anticipated Primary Completion Date :

Dec 17, 2022

Anticipated Study Completion Date :

Dec 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral Treatment Participants diagnosed with OCD will receive 16 sessions (1 hour long) of exposure and response prevention (Ex/RP) delivered twice weekly over the course of eight weeks.	Behavioral: Exposure and Response Prevention (Ex/RP) Ex/RP involves exposure to feared situations, which is expected (and intended for therapeutic benefit) to produce initial moderate anxiety.

Arm

Intervention/Treatment

Experimental: Behavioral Treatment

Participants diagnosed with OCD will receive 16 sessions (1 hour long) of exposure and response prevention (Ex/RP) delivered twice weekly over the course of eight weeks.

Behavioral: Exposure and Response Prevention (Ex/RP)

Ex/RP involves exposure to feared situations, which is expected (and intended for therapeutic benefit) to produce initial moderate anxiety.

Outcome Measures

Primary Outcome Measures

Neural Activity [8 weeks]
EEG will be recorded while participants complete computerized reinforcement learning tasks at two study sessions conducted eight weeks apart.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Between 18-50 years of age
English-speaking
Capacity to provide informed consent
Primary diagnosis of OCD with at least moderate severity

Exclusion Criteria:

Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation
History of any significant medical condition that may increase the risk of participation
Alcohol or substance use disorder in the past year
Exposure and response prevention for OCD within the last six weeks
Currently taking psychotropic medication