International Journal of Clinical Trials | July-September 2021 | Vol 8 | Issue 3 Page 202 International Journal of Clinical Trials Brinkman HR et al. Int J Clin Trials. 2021 Aug;8(3):202-210 http://www.ijclinicaltrials.com pISSN 2349-3240 | eISSN 2349-3259 Protocol Internet-based cognitive behavioral therapy versus internet-based modified present-centered therapy for world trade center responders and survivors with posttraumatic stress disorder: rationale and design of a randomized controlled trial Hannah R. Brinkman 1,2 *, Mary L. Kowalchyk 1 , Leah Cahn 1 , Cindy J. Aaronson 1 , Maria Böttche 3,4 , Candice Presseau 5,6 , John C. Markowitz 7 , Brett T. Litz 5,8,9 , Laura Huckins 1,6,10-13 , Rachel Yehuda 1,6,14 , Christine Knaevelsrud 3 , Robert H. Pietrzak 15,16 , Adriana Feder 1 1 Department of Psychiatry, 10 Department of Genetics and Genomic Sciences, 11 Pamela Sklar Division of Psychiatric Genomics, 12 Icahn Institute for Genomics and Multiscale Biology, 13 Seaver Autism Center for Research and Treatment, 14 Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA 2 Department of Psychology, Rutgers, The State University of New Jersey, New Brunswick, NJ, USA 3 Department of Clinical Psychological Intervention, Freie Universität Berlin, Germany 4 Center Ueberleben, Berlin, Germany 5 VA Boston Healthcare System, Boston, MA, USA 6 Mental Illness Research, Education and Clinical Center, James J. Peters Veterans’ Administration Medical Center, Bronx, New York, USA 7 Department of Psychiatry, Columbia University; New York State Psychiatric Institute, New York, NY, USA 8 Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA 9 Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA 15 Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA 16 United States Department of Veterans Affairs National Center for Post-traumatic Stress Disorder, Clinical Neurosciences Division, VA Connecticut Healthcare System, West Haven, CT, USAA Received: 11 March 2021 Revised: 19 April 2021 Accepted: 21 April 2021 *Correspondence: Hannah R. Brinkman, E-mail: hannah.brinkman@rutgers.edu Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: Nearly two decades following the 9/11/2001 world trade center (WTC) attacks, a substantial proportion of WTC rescue and recovery workers (“responders”) and WTC survivors continue to experience WTC-related posttraumatic stress disorder (PTSD) symptoms. Internet-based cognitive behavioral therapies (I-CBT) are short-term, evidence-based, scalable treatments with the potential to reach large numbers of symptomatic WTC workers and survivors. However, no I- CBT studies have been conducted in the WTC cohort. Methods: This report describes the rationale and design of an ongoing randomized controlled trial comparing integrative testimonial therapy (ITT), an I-CBT, to an active comparison treatment, internet-based modified present-centered therapy. The primary aim is to evaluate the efficacy of ITT in mitigating WTC-related PTSD symptoms in WTC responders and survivors with full or subthreshold WTC-related PTSD. The efficacy of ITT in reducing comorbid depressive and anxiety symptoms, and improving functioning, quality of life, and post-traumatic growth will additionally be evaluated. Saliva samples are also collected to explore genetic and epigenetic biomarkers of treatment response. Conclusions: This is the first I-CBT trial to compare ITT to a credible and active treatment, controlling for critical third- variable explanations of superiority (e.g., non-specific therapy effects). This RCT bridges an important research gap in the rising field of I-CBT interventions and adds to the literature on the design of trials investigating evidence-based treatments for PTSD in WTC- and other trauma-affected populations. Trial registration: This trial was registered on clinicalTrials.gov on May 16, 2017 (NCT03154151). Keywords: Posttraumatic stress disorder, Internet intervention, Online therapy, 9/11, World trade center DOI: https://dx.doi.org/10.18203/2349-3259.ijct20212843