NCT02221518

Brief Summary

The purpose of this study is to examine the brain functioning of OCD patients and healthy controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3.7 years

First QC Date

August 18, 2014

Last Update Submit

March 12, 2019

Conditions

Obsessive-Compulsive Disorder

Keywords

OCDFunctional Magnetic Resonance Imaging (fMRI)

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy

    Baseline & approximately 10 weeks later

Secondary Outcomes (1)

  • Change in reaction times and correct responses on Stop signal reaction time task

    Baseline and approximately 10 weeks later, at second scan

Study Arms (1)

Patients with OCD

EXPERIMENTAL

Behavioral: Exposure \& Response Prevention (EX/RP)

Behavioral: Exposure & Response Prevention (EX/RP)

Interventions

Exposure & Response Prevention (EX/RP)BEHAVIORAL

Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.

Patients with OCD

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and females with OCD aged 18-55
  • Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD
  • Not on psychotropic medication

You may not qualify if:

  • Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging
  • Comorbid psychiatric conditions that significantly elevate the risk of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality)
  • Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure)
  • Use of psychotropic medication
  • Females who are pregnant or post-menopausal
  • \- Male and females aged 18-55
  • Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging
  • Any psychiatric diagnosis
  • Use of psychotropic medication
  • Diagnosis of OCD in a first degree relative
  • Females who are pregnant or post-menopausal
  • Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NY State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (3)

  • Wheaton MG, Kalanthroff E, Mandel M, Marsh R, Simpson HB. Neurocognitive performance in obsessive-compulsive disorder before and after treatment with cognitive behavioral therapy. J Behav Ther Exp Psychiatry. 2025 Jun;87:102019. doi: 10.1016/j.jbtep.2025.102019. Epub 2025 Jan 20.

    PMID: 39879875DERIVED

  • Shi TC, Pagliaccio D, Cyr M, Simpson HB, Marsh R. Network-based functional connectivity predicts response to exposure therapy in unmedicated adults with obsessive-compulsive disorder. Neuropsychopharmacology. 2021 Apr;46(5):1035-1044. doi: 10.1038/s41386-020-00929-9. Epub 2021 Jan 14.

    PMID: 33446895DERIVED

  • Pagliaccio D, Middleton R, Hezel D, Steinman S, Snorrason I, Gershkovich M, Campeas R, Pinto A, Van Meter P, Simpson HB, Marsh R. Task-based fMRI predicts response and remission to exposure therapy in obsessive-compulsive disorder. Proc Natl Acad Sci U S A. 2019 Oct 8;116(41):20346-20353. doi: 10.1073/pnas.1909199116. Epub 2019 Sep 23.

    PMID: 31548396DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Blair Simpson, MD, Ph.D

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry-Columbia University Medical Center, Columbia University; Director of Anxiety Disorders Clinic & Center for OCD and Related Disorders

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

US(1)