Recruiting

ERP

Sponsor:

VA Office of Research and Development

Code:

NCT05240924

Conditions

Obsessive Compulsive Disorder (OCD)

Comorbid Post-Traumatic Stress Disorder and OCD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exposure and Response Prevention

Stress Management Training

Study Details

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.

Conditions

Obsessive Compulsive Disorder (OCD)

Comorbid Post-Traumatic Stress Disorder and OCD

Study ID

NCT05240924

Start date

Oct 3, 2022

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exposure and Response Prevention (ERP)

ERP will be based upon the Treatments That Work series, which contains both a provider manual and client workbook. Sessions will last 90 minutes and occur weekly for 16 sessions. All ERP treatment will be delivered via VTH. Participants will receive instructions on accessing the VTH platform and take part in a brief practice run connecting to the VTH appointment with guidance from an RA. ERP treatment content includes psychoeducation about OCD, assessment of OCD symptoms, the rationale for treatment, construction of a hierarchy or a list of feared or avoided situations, and in-session in-vivo and imaginal exposures. Weekly homework assignments will include self-monitoring, reading chapters about the treatment, and practicing exposures daily. All therapy sessions will be audio-recorded. Although sessions are expected to occur weekly, accounting for delays due to scheduling, holidays, and missed appointments, the investigators will allow up to 6 months to complete the treatment.

other: Control Condition

Participants randomized to the control condition will receive 16 weekly sessions of stress management training via video telehealth. This control condition was chosen because it is expected to provide the therapeutic alliance and common factors associated with therapy generally and some specific effects in anxiety reduction.

Interventions

Exposure 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.

Stress 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.

Primary outcome measure

  • Work and Social Adjustment Scale (WSAS) - Change [ Time Frame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment ]

Central Contacts and Locations

Central contacts

Terri L Fletcher, PhD

(713) 440-4400Terri.Fletcher@va.gov

Matthew G Escamilla, BS

(713) 440-4461matthew.escamilla@va.gov

Locations

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

Recruiting

East Orange, New Jersey, United States, 07018

Contacts

Jennifer Schneider, PhD

347-498-4068Jennifer.Schneider2@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

VA Western New York Healthcare System, Buffalo, NY

Recruiting

Buffalo, New York, United States, 14215-1129

Contacts

Jennifer Schneider, PhD

347-498-4068Jennifer.Schneider2@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

VA NY Harbor Healthcare System, New York, NY

Recruiting

New York, New York, United States, 10010-5011

Contacts

Jennifer Schneider, PhD

347-498-4068Jennifer.Schneider2@va.gov

Matthew, BS

8324681668Matthew.Escamilla@va.gov

Northport VA Medical Center, Northport, NY

Recruiting

Northport, New York, United States, 11768-2200

Contacts

Jennifer Schneider, PhD

347-498-4068Jennifer.Schneider2@va.gov

Matthew Escamilla, BS

8324681668Matthew.Escamilla@va.gov

James J. Peters VA Medical Center, Bronx, NY

Recruiting

The Bronx, New York, United States, 10468-3904

Contacts

Jennifer Schneider, PhD

347-498-4068Jennifer.Schneider2@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

Asheville VA Medical Center, Asheville, NC

Recruiting

Asheville, North Carolina, United States, 28805-2576

Contacts

Holly Hunley, PhD

708-473-1203Holly.Hunley@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Holly Hunley, PhD

708-473-1203Holly.Hunley@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

Fayetteville VA Medical Center, Fayetteville, NC

Recruiting

Fayetteville, North Carolina, United States, 28301-3856

Contacts

Holly Hunley, PhD

708-473-1203Holly.Hunley@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

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

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Holly Hunley, PhD

708-473-1203Holly.Hunley@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

VA Roseburg Healthcare System, Roseburg, OR

Recruiting

Roseburg, Oregon, United States, 97471

Contacts

Milena S Roussev, PhD

206-303-8274Milena.Roussev@va.gov

Matthew G Escamilla, BS

matthew.escamilla@va.gov

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

Recruiting

White City, Oregon, United States, 97503

Contacts

Milena S Roussev, PhD

206-303-8274Milena.Roussev@va.gov

Matthew G Escamilla, BS

Matthew.Escamilla@va.gov

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Ursula S Myers, PhD

843-252-3880ursula.myers@va.gov

Matthew G Escamilla, BS

7137948601matthew.escamilla@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Matthew G Escamilla, BS

(713) 440-4461matthew.escamilla@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Terri L Fletcher, PhD

(713) 440-4400Terri.Fletcher@va.gov

Principal Investigator:

Terri L. Fletcher, PhD

Hampton VA Medical Center, Hampton, VA

Recruiting

Hampton, Virginia, United States, 23667

Contacts

Holly Hunley, PhD

708-473-1203Holly.Hunley@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249-0001

Contacts

Holly Hunley, PhD

708-473-1203Holly.Hunley@va.gov

Matthew Escamilla, BS

8324681668Matthew.Escamilla@va.gov

Salem VA Medical Center, Salem, VA

Recruiting

Salem, Virginia, United States, 24153-6404

Contacts

Holly Hunley, PhD

708-473-1203Holly.Hunley@va.gov

Matthew G Escamilla, BS

8324681668Matthew.Escamilla@va.gov

Spokane VA Medical Center, Spokane, WA

Recruiting

Spokane, Washington, United States, 99205-6185

Contacts

Milena S Roussev, PhD

206-303-8274Milena.Roussev@va.gov

Matthew G Escamilla, BS

matthew.escamilla@va.gov

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

Recruiting

Walla Walla, Washington, United States, 99362-3975

Contacts

Milena S Roussev, PhD

206-303-8274Milena.Roussev@va.gov

Matthew G Escamilla, BS

Matthew.Escamilla@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Obsessive Compulsive Disorder
  • OCD
  • Post-Traumatic Stress Disorder
  • PTSD
  • Worry
  • Compulsion
  • Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-08.