NCT03926546

Brief Summary

The primary objective is to examine the efficacy of implementing evidence based Exposure and Response Prevention (ERP) within group therapy versus individual therapy by monitoring reduction of Obsessive-Compulsive Disorder (OCD) symptomology.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

January 9, 2019

Last Update Submit

May 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive-Compulsive Scale

    Participant OCD severity is measured with Yale-Brown Obsessive-Compulsive Scale over the course of their time in the study. Severity is measured at baseline (week 1), mid (week 3), and post (week 6) participation in ERP over the course of 6 weeks. Severity on the scale is measured based on a score range of 0-40. Participants with scores of 0-13 are considered to have mild symptoms. Scores of 14-25 are considered moderate. 26-34 are considered to be moderate-severe. 35-40 are considered to be very severe.

    Post-treatment, 6 weeks after baseline

Study Arms (2)

Individual ERP

EXPERIMENTAL

Individual Exposure and Response Prevention for OCD

Behavioral: ERP for Individuals

Group ERP

EXPERIMENTAL

Group Exposure and Response Prevention for OCD

Behavioral: ERP for Individuals

Interventions

Comparing Group vs. Individual ERP for OCD

Also known as: ERP for Groups
Group ERPIndividual ERP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be adults 18 years or older.
  • Participants must have the capacity and ability to give informed consent.
  • Participants have been given an assessment and received a diagnosis of OCD.
  • Participants must speak English.
  • Participants must be able to physically attend treatment.

You may not qualify if:

  • Prisoners or any other high-risk population group.
  • experiencing active psychosis
  • experiencing active substance abuse disorder
  • experiencing active suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine Jamail Building

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Elizabeth McIngvale, Ph.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Psychiatry Research

Study Record Dates

First Submitted

January 9, 2019

First Posted

April 24, 2019

Study Start

May 1, 2020

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations