ERP to Improve Functioning in Veterans With OCD

Last updated: March 7, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Obsessive-compulsive Disorder

Treatment

Exposure and Response Prevention

Stress Management Training

Clinical Study ID

NCT05240924
D3677-R
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Veterans having a primary diagnosis of Obsessive Compulsive Disorder (OCD)(50% ofsample) 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) inHouston, TX; the Ralph H. Johnson VA Medical Center in Charleston, SC; the VISN 20Clinical Resource Hub which provides telehealth services to Washington, Oregon, andAlaska: the VISN 2 Clinical Resource Hub which provides telehealth services to NewJersey, New York, and northern Pennsylvania, and the VISN 6 Clinical Resource Hubwhich provides telehealth services to North Carolina and Virginia.

  • Willingness to participate in Exposure and Response Prevention(ERP)

Exclusion

Exclusion Criteria:

  • Significant cognitive impairment or conditions that threaten safety (currentpsychosis, mania, imminent suicidality including plan or intent, andtreatment-interfering moderate to severe substance use).

  • Potential participants taking psychotropic medications must be on a stable dose ofthese medications for at least 6 weeks prior to study enrollment.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Exposure and Response Prevention
Phase:
Study Start date:
October 03, 2022
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

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

    East Orange, New Jersey 07018
    United States

    Active - Recruiting

  • James J. Peters VA Medical Center, Bronx, NY

    Bronx, New York 10468-3904
    United States

    Active - Recruiting

  • VA Western New York Healthcare System, Buffalo, NY

    Buffalo, New York 14215-1129
    United States

    Active - Recruiting

  • VA NY Harbor Healthcare System, New York, NY

    New York, New York 10010-5011
    United States

    Active - Recruiting

  • Northport VA Medical Center, Northport, NY

    Northport, New York 11768-2200
    United States

    Active - Recruiting

  • Asheville VA Medical Center, Asheville, NC

    Asheville, North Carolina 28805-2576
    United States

    Active - Recruiting

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina 27705-3875
    United States

    Active - Recruiting

  • Fayetteville VA Medical Center, Fayetteville, NC

    Fayetteville, North Carolina 28301-3856
    United States

    Active - Recruiting

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

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • VA Roseburg Healthcare System, Roseburg, OR

    Roseburg, Oregon 97471
    United States

    Active - Recruiting

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

    White City, Oregon 97503
    United States

    Active - Recruiting

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina 29401-5703
    United States

    Active - Recruiting

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas 77030-4211
    United States

    Active - Recruiting

  • Hampton VA Medical Center, Hampton, VA

    Hampton, Virginia 23667
    United States

    Active - Recruiting

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia 23249-0001
    United States

    Active - Recruiting

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia 24153-6404
    United States

    Active - Recruiting

  • Spokane VA Medical Center, Spokane, WA

    Spokane, Washington 99205-6185
    United States

    Active - Recruiting

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

    Walla Walla, Washington 99362-3975
    United States

    Active - Recruiting

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