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Obsessive Compulsive Disorder (OCD)NCT05240924

ERP to Improve Functioning in Veterans With OCD

A study testing Exposure and Response Prevention and Stress Management Training in people with Obsessive Compulsive Disorder (OCD) and Comorbid Post-Traumatic Stress Disorder and OCD, run by VA Office of Research and Development at 19 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exposure and Response Prevention and Stress Management Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
19 sitesUnited States
Study dates
3 Oct 2022to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Terri L Fletcher, PhD contact

(713) 440-4400

Terri.Fletcher@va.gov

Matthew G Escamilla, BS contact

(713) 440-4461

matthew.escamilla@va.gov

19 sites in 1 country

United States19 sites, 19 recruiting

  • Asheville VA Medical Center, Asheville, NC

    Asheville, North Carolina, 28805-2576

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

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

  • VA Western New York Healthcare System, Buffalo, NY

    Buffalo, New York, 14215-1129

    Jennifer Schneider, PhD, 347-498-4068, Jennifer.Schneider2@va.gov

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

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

    Charleston, South Carolina, 29401-5703

    Ursula S Myers, PhD, 843-252-3880, ursula.myers@va.gov

    Matthew G Escamilla, BS, 7137948601, matthew.escamilla@va.gov

    Recruiting

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

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

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

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

    East Orange, New Jersey, 07018

    Jennifer Schneider, PhD, 347-498-4068, Jennifer.Schneider2@va.gov

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

  • Fayetteville VA Medical Center, Fayetteville, NC

    Fayetteville, North Carolina, 28301-3856

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

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

  • Hampton VA Medical Center, Hampton, VA

    Hampton, Virginia, 23667

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

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

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

    Houston, Texas, 77030-4211

    Matthew G Escamilla, BS, (713) 440-4461, matthew.escamilla@va.gov

    Terri L. Fletcher, PhD

    Recruiting

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

    Houston, Texas, 77030-4211

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

    Terri L. Fletcher, PhD

    Recruiting

  • VA NY Harbor Healthcare System, New York, NY

    New York, New York, 10010-5011

    Jennifer Schneider, PhD, 347-498-4068, Jennifer.Schneider2@va.gov

    Matthew, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

  • Northport VA Medical Center, Northport, NY

    Northport, New York, 11768-2200

    Jennifer Schneider, PhD, 347-498-4068, Jennifer.Schneider2@va.gov

    Matthew Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001

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

    Matthew Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

  • VA Roseburg Healthcare System, Roseburg, OR

    Roseburg, Oregon, 97471

    Milena S Roussev, PhD, 206-303-8274, Milena.Roussev@va.gov

    Matthew G Escamilla, BS, matthew.escamilla@va.gov

    Recruiting

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia, 24153-6404

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

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

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

    Salisbury, North Carolina, 28144

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

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

  • Spokane VA Medical Center, Spokane, WA

    Spokane, Washington, 99205-6185

    Milena S Roussev, PhD, 206-303-8274, Milena.Roussev@va.gov

    Matthew G Escamilla, BS, matthew.escamilla@va.gov

    Recruiting

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

    The Bronx, New York, 10468-3904

    Jennifer Schneider, PhD, 347-498-4068, Jennifer.Schneider2@va.gov

    Matthew G Escamilla, BS, 8324681668, Matthew.Escamilla@va.gov

    Recruiting

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

    Walla Walla, Washington, 99362-3975

    Milena S Roussev, PhD, 206-303-8274, Milena.Roussev@va.gov

    Matthew G Escamilla, BS, Matthew.Escamilla@va.gov

    Recruiting

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

    White City, Oregon, 97503

    Milena S Roussev, PhD, 206-303-8274, Milena.Roussev@va.gov

    Matthew G Escamilla, BS, Matthew.Escamilla@va.gov

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Exposure and Response Prevention, Stress Management Training
Keywords
Obsessive Compulsive Disorder, OCD, Post-Traumatic Stress Disorder, PTSD, Worry, Compulsion, Stress
Medical subject headings
Obsessive-Compulsive Disorder, Stress Disorders, Post-Traumatic, Compulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure and Response PreventionBehavioural

    Also called ERP

    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 TrainingOther

    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.

Study groups in NCT05240924
Study groupRoleWhat they receive
Exposure and Response Prevention (ERP)ExperimentalERP 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.
Receives: Behavioral: Exposure and Response Prevention
Control ConditionOtherParticipants 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.
Receives: Other: Stress Management Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Work and Social Adjustment Scale (WSAS) - Change

    The WSAS is a 5-item, self-report measure of impairment and functioning across five domains: work, household tasks, relationships, social, and leisure functioning. Respondents rate the impairment due to a specified problem; study participants will be directed to respond regarding impairment caused by OCD. Each item is rated on a 0-8 scale; total scores range from 0 to 40. The WSAS has good internal consistency reliability and validity and has been used to assess changes in functioning in OCD and anxiety disorders in psychotherapy trials. A score of 0-9 (Low impairment), 10-19 (Moderate impairment), and 20-40 (Severe impairment).

    Measured: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

Secondary outcomes (2)

  1. Quality of Life Enjoyment and Satisfaction Questionnaire, short form (QLESQ-SF) - Change

    The QLESQ-SF is a 16-item scale assessing quality of life, enjoyment, and satisfaction across a broad range of domains, including physical health, mood, leisure activities, relationships, and overall sense of well-being. Respondents rate each item on a scale of 1-5. Because the last two items, about medication and overall life enjoyment, are scored separately, scores range from 14 to 70. The QLESQ-SF has good internal consistency reliability and validity and has been used to examine quality of life in OCD and anxiety disorders. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.

    Measured: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

  2. Yale-Brown Obsessive Compulsive Scale, self-report form (Y-BOCS) - Change

    This 10-item questionnaire asks about the frequency and severity of obsessions and compulsions, ability to resist them, and interference from symptoms. Scores can range from 0-40. A score of 8-15 represents mild OCD; 16-23, moderate; 24-31, severe, and above 32, extreme. The self-report Y-BOCS has excellent reliability and validity, and correlates highly with the original clinician-administered interview version. It is frequently used as an outcome measure in randomized controlled trials of ERP. A clinically significant improvement in Y-BOCS score is a 35% reduction.

    Measured: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start3 Oct 2022
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A hybrid type 1 effectiveness-implementation trial evaluating the effectiveness of ERP in Veterans while also assessing the implementation context. This two-arm, participant-level randomized trial will compare ERP to a stress management training control. All participants will receive treatment via video telehealth (VTH). Because one of the primary unanswered questions is whether ERP is effective in individuals with comorbid PTSD, the investigators considered only testing ERP in patients with comorbid PTSD. However, given that the investigators could find no published treatment trials of OCD in Veterans, or trials of OCD delivered via VTH, the investigators believe the effectiveness of ERP in this population must also be tested. Effect sizes in the OCD-only group will serve as comparators for those in the OCD+PTSD group. Implementation context will be evaluated using a mixed-methods formative evaluation guided by the RE-AIM Quest framework.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240924
Sponsor's protocol ID
D3677-R
Status last verified
Jun 2026
First submitted
2 Feb 2022
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ponzini GT, Hundt NE, Christie IC, Chen PV, Ecker AH, Lindsay JA, Teng EJ, Storch EA, Myers US, Roussev MS, Fletcher TL. A protocol for a randomized controlled trial of exposure and response prevention for veterans with obsessive compulsive disorder. Contemp Clin Trials. 2024 Mar;138:107445. doi: 10.1016/j.cct.2024.107445. Epub 2024 Jan 17.

    PubMed 38237674

Questions about this trial

What is this clinical trial studying?

A study testing Exposure and Response Prevention and Stress Management Training in people with Obsessive Compulsive Disorder (OCD) and Comorbid Post-Traumatic Stress Disorder and OCD, run by VA Office of Research and Development at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Terri L Fletcher, PhD ((713) 440-4400, Terri.Fletcher@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Work and Social Adjustment Scale (WSAS) - Change (time frame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05240924, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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