RecruitingNot ApplicableNCT05240924

ERP to Improve Functioning in Veterans With OCD

Exposure and Response Prevention to Improve Functioning in Veterans With Obsessive Compulsive Disorder


Sponsor

VA Office of Research and Development

Enrollment

160 participants

Start Date

Oct 3, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

Interventions

BEHAVIORALExposure and Response Prevention

ERP is a specialized cognitive behavioral intervention conducted over the course of 8-16 therapy sessions. ERP is based upon exposure principles and the idea that people can habituate to the distress caused by OCD triggers and learn to cope with anxiety about feared consequences without engaging in compulsive behaviors to 'neutralize' the obsession. ERP begins with psychoeducation about OCD and exposure, followed by construction of a hierarchy, or list, of situations that are feared, avoided, or trigger OCD rituals such as washing or checking. Then, the therapist and client begin in-session exposures to hierarchy items utilizing response or ritual prevention techniques to avoid reinforcing the ritual. Exposures can be in vivo, such as touching a contaminated item, or imaginal, such as visualizing a feared consequence happening.

OTHERStress Management Training

The stress management training intervention will be based on that delivered by Simpson in an ERP trial. It will be delivered by PhD and Master's level therapists from each site's clinics. The stress management training intervention will begin with an introductory session providing psychoeducation about OCD, followed by 15 sessions covering stress management skills such as deep breathing progressive muscle relaxation, positive imagery, assertiveness training, and problem solving. Each session will contain an extended practice of the selected skill and will end with homework assignments to practice the stress management skills and monitor symptoms.


Locations(18)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, United States

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, United States

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Northport VA Medical Center, Northport, NY

Northport, New York, United States

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Fayetteville VA Medical Center, Fayetteville, NC

Fayetteville, North Carolina, United States

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

Salisbury, North Carolina, United States

VA Roseburg Healthcare System, Roseburg, OR

Roseburg, Oregon, United States

VA Southern Oregon Rehabilitation Center and Clinics, White City, OR

White City, Oregon, United States

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

Salem VA Medical Center, Salem, VA

Salem, Virginia, United States

Spokane VA Medical Center, Spokane, WA

Spokane, Washington, United States

Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA

Walla Walla, Washington, United States

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NCT05240924


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