Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD

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Abstract

This methodological article provides a description of the design, methods, and rationale of the first prospective, noninferiority designed randomized clinical trial evaluating the clinical and cost implications of delivering an evidence-based cognitive-behavioral group intervention specifically treating posttraumatic stress disorder (PTSD) with a trauma-focused intervention via video teleconferencing (VTC). PTSD is a prevalent mental health problem found among returning Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) military populations. These returning military personnel often live in rural areas and therefore have limited access to care and specialized psychological treatments. In the field of mental health, telemental health (TMH) technology has introduced a potential solution to the persistent problem of access to care in remote areas. This study is enrolling approximately 126 returning veterans with current combat-related PTSD who are receiving services through the Veteran Administration (VA) mental health care clinics on 4 Hawaiian Islands. Cognitive Processing Therapy (CPT), an empirically supported manualized treatment for PTSD, is being delivered across 9 cohorts. Participants are assigned to either the experimental VTC condition or the in-person control condition. Assessments measuring clinical, process, and cost outcomes are being conducted at baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment. The study employs a noninferiority design to determine if the group treatment delivered via VTC is as good as the traditional in-person modality. In addition, a cost analysis will be performed in order to compare the cost of the 2 modalities. Novel aspects of this trial and specific challenges are discussed.

Introduction

Posttraumatic Stress Disorder (PTSD) is a serious mental health problem facing military populations across the nation. Estimate rates of PTSD in military populations vary greatly but have been shown to be as high as 70% in some combat theater veteran samples [1]. An estimated 19% of returning Operation Iraqi Freedom (OIF) veterans reported a mental health problem with approximately half of these screening positive for PTSD [2]. Since the Vietnam War, cognitive-behavioral treatments (CBT) have been established as effective in the treatment of PTSD [3], [4]. The Veteran's Affairs (VA) has recently mandated that all veterans, active duty Reserves and National Guardsmen with PTSD be provided access to either of the 2 evidence-based CBT therapies for PTSD, exposure therapy [5] or Cognitive Processing Therapy (CPT) [6]. CPT is a manualized therapy that has demonstrated efficaciousness for both sexual assault victims and veteran populations in VA treatment settings [7], [8] and has been recommended in the Veteran's Health Administration's Clinical Practice Guidelines for PTSD.

Military populations living in rural areas may experience disparities in health status and access to care [9], [10], which have been shown to be a critical barrier to specialty care for many veteran populations [11], [12]. CPT and exposure therapy both require specialized training to deliver; however VA clinics in rural areas are often under-staffed and lack providers who are trained, skilled and comfortable in delivering these treatments. Recent findings suggest that this problem will intensify with over 40% of returning OIF/OEF troops coming from the rural communities [13].

Telehealth is the use of electronic communications and information technology to provide and support health care when distance separates the provider from the patient [14]. Telehealth that is specific to mental health, often referred to as telemental health (TMH), typically includes the provision of psychological services, cognitive testing and general psychiatry. A potential solution to the persistent problem of access to care in remote areas is the use of TMH technologies, such as video teleconferencing (VTC), to deliver care [15], [16], [17]. Several studies have demonstrated the general feasibility and reliability of TMH for both civilians [16], [18] and veterans [19]. However, most TMH applications have involved remote assessment, consultation [20], or psychoeducation [21], [22]; few have examined the provision of psychotherapy or rigorously evaluated whether psychotherapy via VTC produces outcomes that are comparable (noninferior) to those from face-to-face care [19], [21], [23].

Our prior randomized VTC studies with veterans diagnosed with PTSD have used interventions that focused on social skill training and anger management [23], [24] rather than trauma-focused interventions. One of these studies was a small pilot study that was not powered for a noninferiority design [23]. Thus, to date no large, carefully controlled study has examined the use of VTC to conduct an evidence-based PTSD-focused group psychotherapy with a trauma-focused intervention using a rigorous noninferiority design. We have recently launched just such a trial. The aim of this paper is to describe the design, methods, and operational aspects of this novel endeavor that is underway. This paper does not focus on results, but rather we specifically focus on the methodological and procedural issues involved with launching such a study. We delineate the rationale, specific research aims, research design, and analytic approach of an ongoing 4-year randomized clinical trial comparing the effectiveness of a group CPT delivered via VTC to in-person service delivery with a sample of rural combat veterans with PTSD. We focus on four novel features of this trial: 1) methodological issues in testing remote VTC delivery of group psychotherapy; 2) use of a noninferiority design; 3) cost analysis; and 4) selecting a trauma-focused PTSD psychotherapy that is efficacious and likely to be safe and well tolerated.

Section snippets

Study design

This project is a prospective, randomized designed study evaluating the effectiveness of a psychotherapy intervention, CPT, delivered via 2 different modalities (see Fig. 1). The design and methodology of this study allow for a rigorous comparison of the VTC and in-person modalities and a sophisticated analysis of equivalency (noninferiority) between the clinical outcome domains. A noninferiority design is being utilized in order to rigorously assess the equivalency of the 2 treatment

Discussion

The current study examines the efficacy of delivering CPT in a group format through VTC in order to overcome some of the recognized barriers to widespread usage among veterans diagnosed with PTSD; especially among veterans in rural communities. The primary hypothesis is that a novel mode of service delivery, using VTC, will be as effective as the traditional mode of service delivery (in-person) for providing CPT for PTSD on clinical outcomes (symptom severity) and process outcomes

Closing comments

The provision of empirically supported treatments for returning military with PTSD residing in rural locations is a significant challenge to DOD and VA clinicians treating this population. While the VA and DOD have improved their ability to detect and treat the psychiatric disorders that result from combat exposure, it is now time that they take the necessary step to ensure that evidence-based treatments are accessible to all military populations in need of services, regardless of location. In

Acknowledgements

This work is partially supported by Grant PT074516 from the Department of Defense. This work is also supported by the Office of Research and Development, Medical Research Service, Department of Veterans Affairs. All views and opinions expressed herein are those of the authors and do not necessarily reflect those of our respective institutions or the Department of Veterans Affairs.

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