- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06470893
Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study
August 13, 2025 updated by: Kiara Timpano, University of Miami
The overarching goal of this protocol is to investigate mechanisms that influence symptom outcomes of exposure and response prevention (ERP) therapy for OCD.
Mechanisms may include affective processes, learning factors, cognitive factors, or other constructs that could influence treatment outcomes.
The study team will conduct this research within the context of an effective online treatment for OCD called OCD-NET.
OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33146
- University of Miami
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- English-speaking
- Located within the United States
- 18-90 years old
- Able to provide consent
- Current diagnosis of OCD as assessed by clinical interview
Exclusion Criteria:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Participants currently located outside of the United States
- Prisoners
- Participants with hoarding as the primary OCD symptom
- Severe mental illness (e.g. schizophrenia, substance abuse); organic brain syndrome; or serious, current suicidal/homicidal ideation (based on phone screening or initial assessment)
- Concurrent enrollment in another psychotherapy treatment
Participants taking psychotropic medication may be excluded if:
- They have started a brand new psychotropic medication within the last 12 weeks
- They have changed the dose of their psychotropic medication within the last 4 weeks
- They anticipate that they cannot maintain the current dose of their psychotropic medication for the duration of the study
- Participants may be excluded if they have any cognitive or physical impairments that would interfere with their participation (e.g., significant head injury, cognitive disability, dementia).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OCD-NET Group
Participants will receive the OCD-NET intervention for up to 12 months.
|
OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD.
OCD-NET is a self-paced intervention that participants complete entirely online with the support of an assigned individual therapist.
Most participants complete this treatment in up to twelve weeks.
On average, participants are expected to spend between one to five hours per week during the first half of treatment.
In the second half of treatment when participants begin regular exposure and response prevention (ERP) exercises, participants are expected to spend about one hour per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in OCD Symptoms Measured by Yale-Brown Obsessive Compulsive Scale-Second Edition (YBOCS-II)
Time Frame: Baseline, up to 12 months (end of treatment)
|
YBOCS-II scores range from 0-50, and higher scores indicate more severe illness
|
Baseline, up to 12 months (end of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kiara Timpano, PhD, University of Miami
- Principal Investigator: Amelia Dev, MS, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2024
Primary Completion (Actual)
July 8, 2025
Study Completion (Actual)
July 23, 2025
Study Registration Dates
First Submitted
June 17, 2024
First Submitted That Met QC Criteria
June 17, 2024
First Posted (Actual)
June 24, 2024
Study Record Updates
Last Update Posted (Actual)
August 19, 2025
Last Update Submitted That Met QC Criteria
August 13, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20240483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on OCD-NET
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Rush University Medical CenterNational Institutes of Health (NIH); National Center for Advancing Translational...WithdrawnSubstance-Related Disorders | Substance Use | Substance Use Disorders | Psychological Trauma | Trauma and Stress Related DisordersUnited States
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University of KonstanzGerman Research FoundationUnknown