Clinical trial NCT05240924: ERP to Improve Functioning in Veterans With OCD
Official title: Exposure and Response Prevention to Improve Functioning in Veterans With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive Compulsive Disorder (OCD)
Comorbid Post-Traumatic Stress Disorder and OCD
Keywords: Obsessive Compulsive Disorder
OCD
Post-Traumatic Stress Disorder
PTSD
Worry
Compulsion
Stress
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-02-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Work and Social Adjustment Scale (WSAS) - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Secondary outcomes:
measure: Quality of Life Enjoyment and Satisfaction Questionnaire, short form (QLESQ-SF) - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
measure: Yale-Brown Obsessive Compulsive Scale, self-report form (Y-BOCS) - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Other outcomes:
measure: Obsessive-Compulsive Inventory, Revised (OCI-R) - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
measure: Adult OCD Impact Scale (AOIS) - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
measure: Patient Health Questionnaire (PHQ-9) - Depression - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
measure: Quality of Life and Functional Status (SF-12V) - Change
timeFrame: Baseline, Post Treatment (4-6 months after randomization), 6 Months Post Treatment
measure: PTSD Checklist (PCL-5) - PTSD Symptoms - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
measure: Generalized Anxiety Disorder-7 scale (GAD-7) - Anxiety Symptoms - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
measure: Columbia Suicide Severity Rating Scale (C-SSRS) - Suicidality - Change
timeFrame: Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Locations:
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
city: Northport
country: United States
facility: Northport VA Medical Center, Northport, NY
state: New York
city: Asheville
country: United States
facility: Asheville VA Medical Center, Asheville, NC
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Fayetteville
country: United States
facility: Fayetteville VA Medical Center, Fayetteville, NC
state: North Carolina
city: Salisbury
country: United States
facility: Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
state: North Carolina
city: Roseburg
country: United States
facility: VA Roseburg Healthcare System, Roseburg, OR
state: Oregon
city: White City
country: United States
facility: VA Southern Oregon Rehabilitation Center and Clinics, White City, OR
state: Oregon
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: Hampton
country: United States
facility: Hampton VA Medical Center, Hampton, VA
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center, Salem, VA
state: Virginia
city: Spokane
country: United States
facility: Spokane VA Medical Center, Spokane, WA
state: Washington
city: Walla Walla
country: United States
facility: Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA
state: Washington
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Terri L. Fletcher, PhD
role: PRINCIPAL_INVESTIGATOR
References: