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

Morland, Leslie A.; Greene, Carolyn J.; Rosen, Craig; Mauldin, Patrick D.; Frueh, B. Christopher

doi:10.1016/j.cct.2009.06.006

Cited by 47Telemedicine and Telehealth ImplementationPosttraumatic Stress Disorder ResearchStatistical Methods in Clinical Trials

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

Morland, Leslie A., Greene, Carolyn J., Rosen, Craig, Mauldin, Patrick D., Frueh, B. Christopher·2009·Contemporary Clinical Trials

DOI 10.1016/j.cct.2009.06.006

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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.

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An on-site clinical navigator may help personalize televideo care, guide patients through encounters, and prevent undue emotional escalation.
“an on-site clinical navigator may help make the experience more personal,47 help patients navigate clinical encounters,48 and safeguard against undue emotional escalations.49”
From Task-sharing approaches to improve mental health care in rural and other low-resource settings: a systematic review (2018) · cites this paper as [49]

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TELEMEDICINE VERSUS IN-PERSON DELIVERY OF COGNITIVE PROCESSING THERAPY FOR WOMEN WITH POSTTRAUMATIC STRESS DISORDER: A RANDOMIZED NONINFERIORITY TRIAL: Research Article: Telemental Health<i>for</i>Women<i>with PTSD</i>
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Self-citation

Authors: Morland, L. A., Greene, C. J., Rosen, C., Mauldin, P. D., & Frueh, B. C.
Affiliations: National Center for PTSD (US)
VA Palo Alto Health Care System (US)
Medical University of South Carolina (US)
Baylor College of Medicine (US)
Corresponding author: Morland, Leslie A.
ORCID: Morland, Leslie A.
Greene, Carolyn J.
Rosen, Craig
Mauldin, Patrick D.
Frueh, B. Christopher
Venue: Contemporary Clinical Trials
Publisher: Elsevier BV
Published: 2009-11
Volume: 30
Issue: 6
Pages: 513-522
ISSN: 1551-7144 (ISSN-L)
DOI: 10.1016/j.cct.2009.06.006
OpenAlex: W2076952499
Cited by: 47
References: 57
Citations by year: 2026: 1 · 2023: 1 · 2022: 2 · 2021: 1 · 2020: 4 · 2019: 3 · 2017: 2 · 2016: 4 · 2015: 5 · 2014: 3 · 2013: 10 · 2012: 6
FWCI: 3.69
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Contemporary Clinical Trials (publishedVersion)
PubMed (publishedVersion)
Funders: Office of Research and Development
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: telemental health, post-traumatic stress disorder, combat veterans, cognitive processing therapy, videoconferencing, cost analysis, group therapy
MeSH terms: Hawaii, Humans, Mental Health Services, Prospective Studies, Psychotherapy, Research Design, Stress Disorders, Post-Traumatic, Veterans, Telemedicine, Rural Health Services

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

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