Back to resultsOpen/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Primary Purpose
OCD
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Pharmacotherapy
Sponsored by
About this trial
This is an interventional treatment trial for OCD focused on measuring treatment, psychotherapy, pharmacotherapy
Eligibility Criteria
Inclusion Criteria:
- Ability to speak and understand English
- Capacity to consent (e.g. as determined by assessing the patient's understanding of the risks, benefits, and procedures of the study)
- Completed an active study protocol at the Rodriguez Lab at Stanford University
Exclusion Criteria:
- Children younger than 18
- Active suicidality
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Psychotherapy
Pharmacotherapy
Arm Description
Participants will receive evidenced based psychotherapy by a trained psychologist
Participants will receive pharmacotherapy by a psychiatrist
Outcomes
Primary Outcome Measures
Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03511534
Brief Title
Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Official Title
Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to provide participants diagnosed with obsessive compulsive disorder (OCD) and completed one of the active study protocols at the Rodriguez Lab, with open/aftercare treatment.
Detailed Description
After completing one of the active clinical studies participants have the option to enroll in this protocol that offers open treatment.
The goal is to compare two forms of current standard treatments, psychotherapy vs pharmacotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OCD
Keywords
treatment, psychotherapy, pharmacotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will choose to enter the psychotherapy or pharmacotherapy arm.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psychotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive evidenced based psychotherapy by a trained psychologist
Arm Title
Pharmacotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive pharmacotherapy by a psychiatrist
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Evidenced based psychotherapy by a trained psychologist
Intervention Type
Other
Intervention Name(s)
Pharmacotherapy
Intervention Description
Pharmacotherapy by a psychiatrist
Primary Outcome Measure Information:
Title
Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Description
Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.
Time Frame
Up to 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to speak and understand English
Capacity to consent (e.g. as determined by assessing the patient's understanding of the risks, benefits, and procedures of the study)
Completed an active study protocol at the Rodriguez Lab at Stanford University
Exclusion Criteria:
Children younger than 18
Active suicidality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Varias, MSHS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Filippou-Frye, MD, MBS
Phone
650-723-4095
Email
mariafilippoufrye@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Rodriguez, MD, PhD
Organizational Affiliation
Assistant Professor, Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Varias, MSHS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name & Degree
Maria Filippou-Frye, MD, MBS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
12. IPD Sharing Statement
Learn more about this trial
Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
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