NCT05240924 ERP to Improve Functioning in Veterans With OCD
| NCT ID | NCT05240924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Obsessive Compulsive Disorder (OCD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-10-03 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-10-03 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Obsessive compulsive disorder (OCD) is a debilitating psychiatric illness impacting work, social, and family functioning. Exposure and Response Prevention (ERP) is the sole evidence-based psychotherapy for OCD; however, no randomized controlled trials (RCTs) have examined the effectiveness of ERP among Veterans or individuals with both OCD and posttraumatic stress disorder (PTSD). This 4-year Hybrid Type I trial will compare outcomes of ERP to those of a control condition among Veterans with OCD. Primary and secondary aims will examine whether Veterans' functioning, quality of life, and OCD symptoms differ between the ERP and control in the full sample of Veterans with OCD, and in the half of the sample with both OCD and PTSD. The tertiary aim is to conduct a mixed-methods formative evaluation of the implementation potential of ERP in VA mental health settings.
Eligibility Criteria
Inclusion Criteria: * Veterans having a primary diagnosis of Obsessive Compulsive Disorder (OCD)(50% of sample) and comorbid OCD and Post-traumatic stress disorder (PTSD) (50% of sample) who are receiving care from the Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, TX; the Ralph H. Johnson VA Medical Center in Charleston, SC; the VISN 20 Clinical Resource Hub which provides telehealth services to Washington, Oregon, and Alaska: the VISN 2 Clinical Resource Hub which provides telehealth services to New Jersey, New York, and northern Pennsylvania, and the VISN 6 Clinical Resource Hub which provides telehealth services to North Carolina and Virginia. * Willingness to participate in Exposure and Response Prevention(ERP) Exclusion Criteria: * Significant cognitive impairment or conditions that threaten safety (current psychosis, mania, imminent suicidality including plan or intent, and treatment-interfering moderate to severe substance use). * Potential participants taking psychotropic medications must be on a stable dose of these medications for at least 6 weeks prior to study enrollment.
Contact & Investigator
Terri L. Fletcher, PhD
PRINCIPAL INVESTIGATOR
Michael E. DeBakey VA Medical Center, Houston, TX
Frequently Asked Questions
Who can join the NCT05240924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obsessive Compulsive Disorder (OCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05240924 currently recruiting?
Yes, NCT05240924 is actively recruiting participants. Contact the research team at matthew.escamilla@va.gov for enrollment information.
Where is the NCT05240924 trial being conducted?
This trial is being conducted at East Orange, United States, Buffalo, United States, New York, United States, Northport, United States and 11 additional locations.
Who is sponsoring the NCT05240924 clinical trial?
NCT05240924 is sponsored by VA Office of Research and Development. The principal investigator is Terri L. Fletcher, PhD at Michael E. DeBakey VA Medical Center, Houston, TX. The trial plans to enroll 160 participants.