A protocol for a randomized controlled trial of exposure and response prevention for veterans with obsessive compulsive disorder

Gabriella T Ponzini; Natalie E Hundt; Israel C Christie; Patricia V Chen; Anthony H Ecker; Jan A Lindsay; Ellen J Teng; Eric A Storch; Ursula S Myers; Milena S Roussev; Terri L Fletcher

doi:10.1016/j.cct.2024.107445

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.

Authors

Affiliations

¹ Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Health Care System, 411 W. Chapel Hill St., Durham, NC 27701, USA. Electronic address: Gabriella.Ponzini@va.gov.
² VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030, USA; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA; VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX (a virtual center), USA. Electronic address: Natalie.Hundt@bcm.edu.
³ VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030, USA; Department of Medicine, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA. Electronic address: Israel.Christie@bcm.edu.
⁴ VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030, USA; Department of Medicine, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA. Electronic address: patricic@bcm.edu.
⁵ VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030, USA; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA; VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX (a virtual center), USA. Electronic address: Anthony.Ecker@bcm.edu.
⁶ VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030, USA; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA; VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX (a virtual center), USA. Electronic address: jalindsa@nbcm.edu.
⁷ Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA; Mental Health Care Line, Michael E. DeBakey VA Medical Center, 2002 Holcombe Blvd., Houston, TX 77030, USA. Electronic address: Ellen.Teng@va.gov.
⁸ Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA. Electronic address: Eric.Storch@bcm.edu.
⁹ Charleston Health Equity and Rural Outreach Innovation Center and Mental Health Service Line, Ralph H. Johnson Health Care System, Charleston, SC, USA; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 109 Bee St., Charleston, SC 29401, USA. Electronic address: Ursula.Myers@va.gov.
¹⁰ VISN 20 Clinical Resource Hub, 500 W. Fort St., Boise, ID 83702, USA. Electronic address: Milena.Roussev@va.gov.
¹¹ VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030, USA; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA; VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX (a virtual center), USA. Electronic address: terrif@bcm.edu.

PMID: 38237674
DOI: 10.1016/j.cct.2024.107445

Abstract

Background: Obsessive compulsive disorder (OCD) is effectively treated with exposure and response prevention (ERP), yet very few veterans receive ERP for OCD within the Veterans Health Administration (VHA). Veterans are a clinically complex population, and no prior research has evaluated the effectiveness of ERP in veterans with OCD or comorbid OCD and posttraumatic stress disorder (PTSD). Given the limited accessibility of ERP-trained providers within VHA, assessment of video telehealth (VTH) delivery of ERP is warranted.

Methods: A sample of 160 veterans with OCD (80 diagnosed with comorbid PTSD) will be randomly assigned to receive up to 16 sessions of ERP or a stress management training control delivered via VTH. Assessments will occur at baseline, posttreatment, and 6-month follow-up. The primary outcome will evaluate the impact of ERP on participants' functioning, and secondary outcomes will include quality of life and OCD symptoms. At posttreatment, qualitative interviews with veterans, clinicians, and administrators will explore barriers and facilitators to treatment delivery, and the implementation potential of ERP.

Conclusions: Results will provide direction for the treatment of OCD and comorbid PTSD in veterans, as well as guidance for future implementation efforts for ERP within VHA.

Clinicaltrials: gov Identifier:NCT05240924.

Keywords: Exposure and response prevention; OCD; Randomized-controlled trial; Veterans.

Published by Elsevier Inc.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Implosive Therapy* / methods
Obsessive-Compulsive Disorder* / epidemiology
Obsessive-Compulsive Disorder* / therapy
Quality of Life
Randomized Controlled Trials as Topic
Treatment Outcome
Veterans*

Associated data

ClinicalTrials.gov/NCT05240924