ERP to Improve Functioning in Veterans With OCD
- Conditions
- Obsessive Compulsive Disorder (OCD)Comorbid Post-Traumatic Stress Disorder and OCD
- Interventions
- Behavioral: Exposure and Response PreventionOther: Stress Management Training
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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)
- 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
- Arm && Interventions
Group Intervention Description Exposure and Response Prevention (ERP) Exposure and Response Prevention 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. Control Condition Stress Management Training 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.
- 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
VA Southern Oregon Rehabilitation Center and Clinics, White City, OR
🇺🇸White City, Oregon, United States
Ralph H. Johnson VA Medical Center, Charleston, SC
🇺🇸Charleston, South Carolina, United States
Michael E. DeBakey VA Medical Center, Houston, TX
🇺🇸Houston, Texas, United States
Hampton VA Medical Center, Hampton, VA
🇺🇸Hampton, Virginia, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
🇺🇸Richmond, Virginia, United States
Salem VA Medical Center, Salem, VA
🇺🇸Salem, Virginia, United States
Spokane VA Medical Center, Spokane, WA
🇺🇸Spokane, Washington, United States
Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA
🇺🇸Walla Walla, Washington, United States