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Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD.
Contemp Clin Trials. 2009 Nov; 30(6):513-22.CC

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.

Authors+Show Affiliations

National Center for PTSD - Pacific Islands Division, Department of Veterans Affairs Pacific Islands Healthcare System, Honolulu, HI 96819, USA. Leslie.Morland@va.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

19576299

Citation

Morland, Leslie A., et al. "Issues in the Design of a Randomized Noninferiority Clinical Trial of Telemental Health Psychotherapy for Rural Combat Veterans With PTSD." Contemporary Clinical Trials, vol. 30, no. 6, 2009, pp. 513-22.
Morland LA, Greene CJ, Rosen C, et al. Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD. Contemp Clin Trials. 2009;30(6):513-22.
Morland, L. A., Greene, C. J., Rosen, C., Mauldin, P. D., & Frueh, B. C. (2009). Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD. Contemporary Clinical Trials, 30(6), 513-22. https://doi.org/10.1016/j.cct.2009.06.006
Morland LA, et al. Issues in the Design of a Randomized Noninferiority Clinical Trial of Telemental Health Psychotherapy for Rural Combat Veterans With PTSD. Contemp Clin Trials. 2009;30(6):513-22. PubMed PMID: 19576299.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD. AU - Morland,Leslie A, AU - Greene,Carolyn J, AU - Rosen,Craig, AU - Mauldin,Patrick D, AU - Frueh,B Christopher, Y1 - 2009/07/01/ PY - 2009/03/21/received PY - 2009/06/06/revised PY - 2009/06/18/accepted PY - 2009/7/7/entrez PY - 2009/7/7/pubmed PY - 2010/1/13/medline SP - 513 EP - 22 JF - Contemporary clinical trials JO - Contemp Clin Trials VL - 30 IS - 6 N2 - 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. SN - 1559-2030 UR - https://www.unboundmedicine.com/medline/citation/19576299/Issues_in_the_design_of_a_randomized_noninferiority_clinical_trial_of_telemental_health_psychotherapy_for_rural_combat_veterans_with_PTSD_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1551-7144(09)00111-6 DB - PRIME DP - Unbound Medicine ER -