ERP to Improve Functioning in Veterans With OCD

Not Applicable

Recruiting

• Conditions: Obsessive Compulsive Disorder (OCD); Comorbid Post-Traumatic Stress Disorder and OCD

• Registration Number: NCT05240924
• Lead Sponsor: VA Office of Research and Development

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.

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.

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Study Start: 2022-10-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-10-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Work and Social Adjustment Scale (WSAS) - Change	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life Enjoyment and Satisfaction Questionnaire, short form (QLESQ-SF) - Change	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment	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.
Yale-Brown Obsessive Compulsive Scale, self-report form (Y-BOCS) - Change	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment	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.

Trial Locations

Locations (18)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ; 🇺🇸 East Orange, New Jersey, United States

James J. Peters VA Medical Center, Bronx, NY; 🇺🇸 Bronx, New York, 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

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

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