Back to Trials
NCT05240924NARecruiting

ERP to Improve Functioning in Veterans With OCD

VA Office of Research and Development

Start Date

10/3/2022

Completion Date

5/31/2027

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.

Detailed Description

The proposed 4-year multisite RCT will compare outcomes of VTH-delivered ERP to those of a stress management training control condition among 160 Veterans with OCD. Half of the sample with have comorbid PTSD. The primary aim will examine whether participants' functioning, quality of life, and OCD symptoms differ as a function of the intervention (ERP vs. control). The secondary aim will examine these outcomes among the half of the sample with comorbid 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. Eligible Veteran participants will be randomized to ERP or to the control condition. Veterans randomized to ERP will receive 16 weekly ERP sessions delivered via VTH. Control participants will receive 16 weekly sessions of a stress management training intervention delivered via VTH. Participants in both conditions will complete assessments at post-treatment and 6 months after completing treatment. Participants in the ERP condition will also complete an assessment of treatment satisfaction and a qualitative exit interview assessing the Veterans' perceptions of the impact of treatment on multiple domains of functioning, including the impact on PTSD symptoms. Providers and VA administrators will participate in qualitative interviews regarding the implementation potential of ERP in VA.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BEHAVIORAL

Exposure and Response Prevention

OTHER

Stress Management Training

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Obsessive Compulsive Disorder (OCD)Comorbid Post-Traumatic Stress Disorder and OCD

Locations

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

East Orange, New Jersey 07018

United States

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York 14215-1129

United States

VA NY Harbor Healthcare System, New York, NY

New York, New York 10010-5011

United States

Northport VA Medical Center, Northport, NY

Northport, New York 11768-2200

United States

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York 10468-3904

United States

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina 28805-2576

United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina 27705-3875

United States

Fayetteville VA Medical Center, Fayetteville, NC

Fayetteville, North Carolina 28301-3856

United States

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

Salisbury, North Carolina 28144

United States

VA Roseburg Healthcare System, Roseburg, OR

Roseburg, Oregon 97471

United States

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

White City, Oregon 97503

United States

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina 29401-5703

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas 77030-4211

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas 77030-4211

United States

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia 23667

United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia 23249-0001

United States

Salem VA Medical Center, Salem, VA

Salem, Virginia 24153-6404

United States

Spokane VA Medical Center, Spokane, WA

Spokane, Washington 99205-6185

United States

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

Walla Walla, Washington 99362-3975

United States