Massed versus standard prolonged exposure for posttraumatic stress disorder in Australian military and veteran populations (RESTORE trial): Study protocol for a non-inferiority randomized controlled trial

Contemporary Clinical Trials - Tập 107 - Trang 106478 - 2021
Lisa Dell1, Alyssa M. Sbisa1, Meaghan O'Donnell1, Peter W. Tuerk2, Richard Bryant3, Stephanie Hodson4, David Morton5, Malcolm Battersby6, Andrew Forbes7, David Forbes1
1Phoenix Australia Centre for Posttraumatic Mental Health, Department of Psychiatry, The University of Melbourne, Carlton, VIC, Australia
2Sheila C. Jonson Centre for Clinical Services, Department of Human Services, University of Virginia, Charlottesville, VA, USA
3School of Psychology, University of New South Wales, Sydney, NSW, Australia
4Department of Veteran's Affairs, Canberra, ACT, Australia
5Department of Defence, Canberra, ACT, Australia
6College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia
7School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia

Tài liệu tham khảo

Richardson, 2010, Prevalence estimates of combat-related post-traumatic stress disorder: critical review, Aust. N. Z. J. Psychiatry, 44, 4, 10.3109/00048670903393597 Gates, 2012, Posttraumatic stress disorder in veterans and military personnel: epidemiology, screening, and case recognition, Psychol. Serv., 9, 361, 10.1037/a0027649 Forbes, 2003, Comorbidity as a predictor of symptom change after treatment in combat-related posttraumatic stress disorder, J. Nerv. Ment. Dis., 191, 93, 10.1097/01.NMD.0000051903.60517.98 O’Donnell, 2004, Psychiatric morbidity following injury, Am. J. Psychiatr., 161, 507, 10.1176/appi.ajp.161.3.507 Australian Centre for Posttraumatic Mental Health, 2013 American Psychiatric Association, 2004 National Institute for Health and Clinical Excellence, 2005 Foa, 2007 Department of Veterans Affairs/Department of Defense, 2010 Institute of Medicine, 2007 Brown, 2019, Mechanisms of change in prolonged exposure therapy for PTSD: implications for clinical practice, J. Psychother. Integr., 29, 6, 10.1037/int0000109 Cooper, 2017, An empirical review of potential mediators and mechanisms of prolonged exposure therapy, Clin. Psychol. Rev., 56, 106, 10.1016/j.cpr.2017.07.003 Haagen, 2015, The efficacy of recommended treatments for veterans with PTSD: a metaregression analysis, Clin. Psychol. Rev., 40, 184, 10.1016/j.cpr.2015.06.008 Forbes, 2018 Fikretoglu, 2008, Twelve month use of mental health services in a nationally representative, active military sample, Med. Care, 46, 217, 10.1097/MLR.0b013e31815b979a Ramchand, 2015, Prevalence of, risk factors for, and consequences of posttraumatic stress disorder and other Mental Health Problems in Military Populations Deployed to Iraq and Afghanistan, Curr. Psychiatry Rep., 17(5) Sharp, 2015, Stigma as a barrier to seeking health care among military personnel with mental health problems, Epidemiol. Rev., 37, 144, 10.1093/epirev/mxu012 Hall-Clark, 2019, Military culture considerations in prolonged exposure therapy with active-duty military service members, Cogn. Behav. Pract., 26, 335, 10.1016/j.cbpra.2018.07.009 Telch, 2014, Exposure therapy, 717 Blount, 2014, Intensive outpatient prolonged exposure for combat-related PTSD: a case study, Cogn. Behav. Pract., 21, 89, 10.1016/j.cbpra.2013.05.004 Yasinski, 2017, Intensive outpatient prolonged exposure for PTSD in post-9/11 veterans and service-members: program structure and preliminary outcomes of the Emory Healthcare Veterans Program, Trauma Psychol. News, 12 Foa, 2018, Effect of prolonged exposure therapy delivered over 2 weeks vs 8 weeks vs present-centered therapy on PTSD symptom severity in military personnel: a randomized clinical trial, JAMA, 319, 354, 10.1001/jama.2017.21242 Schumi, 2011, Through the looking glass: understanding non-inferiority, Trials, 12, 106, 10.1186/1745-6215-12-106 Chan, 2013, SPIRIT 2013 statement: defining standard protocol items for clinical trials, Ann. Intern. Med., 158, 200, 10.7326/0003-4819-158-3-201302050-00583 Weathers, 2013 Sheehan, 2015 Wade, 2012, Examination of the latent factor structure of the Alcohol Use Disorders Identification Test in two independent trauma patient groups using confirmatory factor analysis, J. Subst. Abus. Treat., 43, 123, 10.1016/j.jsat.2011.10.023 Monson, 2006, Cognitive processing therapy for veterans with military-related posttraumatic stress disorder, J. Consult. Clin. Psychol., 74, 898, 10.1037/0022-006X.74.5.898 Sloan, 2016, Brief treatment for PTSD: a non-inferiority trial, Contemp Clin Trials, 48, 76, 10.1016/j.cct.2016.04.003 Weathers, 2013 Weathers Zigmond, 1983, The hospital anxiety and depression scale, Acta Psychiatr. Scand., 67, 361, 10.1111/j.1600-0447.1983.tb09716.x Forbes, 2014, Utility of the dimensions of anger reactions – 5 (DAR-5) scale as a brief anger measure, Depress. Anxiety, 31, 166, 10.1002/da.22148 Babor, 2001 Bush, 1998, The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking, Arch. Intern. Med., 158, 1789, 10.1001/archinte.158.16.1789 Üstün, 2010 Maxwell, 2016, Deriving population norms for the AQoL-6D and AQoL-8D multi-attribute utility instruments from web-based data, Qual. Life Res., 25, 3209, 10.1007/s11136-016-1337-z Cox, 2000 Devilly, 2000, Psychometric properties of the credibility/expectancy questionnaire, J. Behav. Ther. Exp. Psychiatry, 31, 73, 10.1016/S0005-7916(00)00012-4 Weathers, 2018, The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): development and initial psychometric evaluation in military veterans, Psychol. Assess., 30, 383, 10.1037/pas0000486 Blevins, 2015, The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): development and initial psychometric evaluation, J. Trauma. Stress., 28, 489, 10.1002/jts.22059 Bovin, 2015, Psychometric properties of the PTSD checklist for diagnostic and statistical manual of mental disorders-fifth edition (PCL-5) in veterans, Psychol. Assess., 28, 1379, 10.1037/pas0000254 Wortmann, 2016, Psychometric analysis of the PTSD Checklist-5 (PCL-5) among treatment-seeking military service members, Psychol. Assess., 28, 1392, 10.1037/pas0000260 Bjelland, 2002, Review: the validity of the hospital anxiety and depression scale. An updated literature review, J. Psychosom. Res., 52, 69, 10.1016/S0022-3999(01)00296-3 Forbes, 2014, Evaluation of the Dimensions of Anger Reactions-5 (DAR-5) scale in combat veterans with posttraumatic stress disorder, J. Anxiety Disord., 28, 830, 10.1016/j.janxdis.2014.09.015 Allen, 2013, Construct validity of the Assessment of Quality of Life – 6D (AQoL-6D) in community samples, Health Qual. Life Outcomes, 11, 1, 10.1186/1477-7525-11-61 Marx, 2015, Using the WHODAS 2.0 to assess functioning among veterans seeking compensation for Posttraumatic Stress Disorder, Psychiatr. Serv., 66, 1312, 10.1176/appi.ps.201400400 Bradley, 2007, AUDIT-C as a brief screen for alcohol misuse in primary care, Alcohol. Clin. Exp. Res., 31, 1208, 10.1111/j.1530-0277.2007.00403.x Bradley, 2003, Two brief alcohol-screening tests from the alcohol use disorders identification test (AUDIT): validation in a female veterans affairs patient population, Arch. Intern. Med., 163, 821, 10.1001/archinte.163.7.821 PTSD, P.N.C.f Gray, 2004, Psychometric properties of the life events checklist, Assessment, 11, 330, 10.1177/1073191104269954 Dobson, 2012 Van Hooff, 2018 Brugha, 1985, The list of threatening experiences: a subset of 12 life event categories with considerable long-term contextual threat, Psychol. Med., 15, 189, 10.1017/S003329170002105X Brugha, 1990, The list of threatening experiences: the reliability and validity of a brief life events questionnaire, Acta Psychiatr. Scand., 82, 77, 10.1111/j.1600-0447.1990.tb01360.x Horvath, 1989, Development and validation of the working Alliance inventory, J. Couns. Psychol., 36, 223, 10.1037/0022-0167.36.2.223 Tracey, 1989, Factor structure of the working Alliance inventory, Psychol. Assess., 1, 207, 10.1037/1040-3590.1.3.207 Pole, 2007, The psychophysiology of posttraumatic stress disorder: a meta-analysis, Psychol. Bull., 133, 725, 10.1037/0033-2909.133.5.725 Wahbeh, 2013, Skin conductance response during laboratory stress in combat veterans with posttraumatic stress disorder, Journal Of Trauma & Treatment, 2, 10.4172/2167-1222.1000167 Wangelin, 2015, Taking the pulse of prolonged exposure therapy: physiological reactivity to trauma imagery as an objective measure of treatment response, Depression And Anxiety, 32, 927, 10.1002/da.22449 Hörmann, 2016, Fine-grained prediction of cognitive workload in a modern working environment by utilizing short-term physiological parameters D’Agostino, 2003, Non-inferiority trials: design concepts and issues – the encounters of academic consultants in statistics, Stat. Med., 22, 169, 10.1002/sim.1425 Smith, 2013, Two-group randomised, parallel trial of cognitive and exposure therapies for problem gambling: a research protocol, BMJ Open, 3 Ellenberg, 2002, Data Monitoring Committees in clinical Trials: A Practical Perspective Steenkamp, 2015, Psychotherapy for military-related PTSD: a review of randomized clinical trials, Jama, 314, 489, 10.1001/jama.2015.8370 Ehlers, 2014, A randomized controlled trial of 7-day intensive and standard weekly cognitive therapy for PTSD and emotion-focused supportive therapy, Am. J. Psychiatr., 171, 294, 10.1176/appi.ajp.2013.13040552 Ehlers, 2010, Intensive cognitive therapy for PTSD: a feasibility study, Behav. Cogn. Psychother., 38, 383, 10.1017/S1352465810000214 Zoellner, 2011, Teaching trauma-focused exposure therapy for PTSD: critical clinical lessons for novice exposure therapists, Psychol. Trauma Theory Res. Pract. Policy, 3, 300, 10.1037/a0024642 Forbes, 2012, A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder., J. Anxiety Disord., 23, 442, 10.1016/j.janxdis.2012.01.006