ERP to Improve Functioning in Veterans With OCD

Official title

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

Overview

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.

Interventions

• Behavioral 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
• Other 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 wil

Primary outcome measures

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

Secondary outcome measures (2)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 19 centers

• East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ — East Orange
• VA Western New York Healthcare System, Buffalo, NY — Buffalo
• VA NY Harbor Healthcare System, New York, NY — New York
• Northport VA Medical Center, Northport, NY — Northport
• James J. Peters VA Medical Center, Bronx, NY — The Bronx
• Asheville VA Medical Center, Asheville, NC — Asheville
• Durham VA Medical Center, Durham, NC — Durham
• Fayetteville VA Medical Center, Fayetteville, NC — Fayetteville
• … and 11 more centers

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. PMID 38237674

Identifiers

NCT: NCT05240924 · D3677-R

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗