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Individual Versus Group Exposure With Response Prevention (ERP) for the Treatment of Obsessive Compulsive Disorder (OCD)

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ClinicalTrials.gov Identifier: NCT03926546
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth McIngvale, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
OCD Behavioral: ERP for Individuals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individual Versus Group Exposure and Response Prevention Therapy for the Treatment of Obsessive-Compulsive Disorder
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individual ERP
Individual Exposure and Response Prevention for OCD
Behavioral: ERP for Individuals
Comparing Group vs. Individual ERP for OCD
Other Name: ERP for Groups

Experimental: Group ERP
Group Exposure and Response Prevention for OCD
Behavioral: ERP for Individuals
Comparing Group vs. Individual ERP for OCD
Other Name: ERP for Groups




Primary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Scale [ Time Frame: Post-treatment, 6 weeks after baseline ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926546


Contacts
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Contact: Elizabeth McIngvale, Ph.D. 713-798-3080 elizabeth.mcingvale@bcm.edu
Contact: Cali Roper 713-798-3080 cali.roper@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Jamail Building Enrolling by invitation
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Elizabeth McIngvale, Ph.D. Baylor College of Medicine

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Responsible Party: Elizabeth McIngvale, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03926546     History of Changes
Other Study ID Numbers: H-44611
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders