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

Abstract

<p><strong>Background:</strong> 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.</p><p><strong>Methods:</strong> 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.</p><p><strong>Conclusions: </strong>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. </p><p><strong>Trial registration: </strong>This trial was registered on clinicalTrials.gov on May 16, 2017 (NCT03154151).</p>