@Article{info:doi/10.2196/30813, author="Petrinec, Amy B and Hughes, Joel W and Zullo, Melissa D and Wilk, Cindy and George, Richard L", title="Smartphone Delivery of Cognitive Behavioral Therapy for Postintensive Care Syndrome-Family: Protocol for a Pilot Study", journal="JMIR Res Protoc", year="2021", month="Aug", day="4", volume="10", number="8", pages="e30813", keywords="postintensive care syndrome-family; mobile health app; cognitive behavioral therapy; mobile phone", abstract="Background: Family members of critically ill patients experience symptoms of postintensive care syndrome-family (PICS-F), including anxiety, depression, and posttraumatic stress disorder. Postintensive care syndrome-family reduces the quality of life of the families of critically ill patients and may impede the recovery of such patients. Cognitive behavioral therapy has become a first-line nonpharmacological treatment of many psychological symptoms and disorders, including anxiety, depression, and posttraumatic stress. With regard to managing mild-to-moderate symptoms, the delivery of cognitive behavioral therapy via mobile technology without input from a clinician has been found to be feasible and well accepted, and its efficacy rivals that of face-to-face therapy. Objective: The purpose of our pilot study is to examine the efficacy of using a smartphone mobile health (mHealth) app to deliver cognitive behavioral therapy and diminish the severity and prevalence of PICS-F symptoms in family members of critically ill patients. Methods: For our pilot study, 60 family members of critically ill patients will be recruited. A repeated-measures longitudinal study design that involves the randomization of participants to 2 groups (the control and intervention groups) will be used. The intervention group will receive cognitive behavioral therapy, which will be delivered via a smartphone mHealth app. Bandura's social cognitive theory and an emphasis on mental health self-efficacy form the theoretical framework of the study. Results: Recruitment for the study began in August 2020. Data collection and analysis are expected to be completed by March 2022. Conclusions: The proposed study represents a novel approach to the treatment of PICS-F symptoms and is an extension of previous work conducted by the research team. The study will be used to plan a fully powered randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT04316767; https://clinicaltrials.gov/ct2/show/NCT04316767 International Registered Report Identifier (IRRID): DERR1-10.2196/30813 ", issn="1929-0748", doi="10.2196/30813", url="https://www.researchprotocols.org/2021/8/e30813", url="https://doi.org/10.2196/30813", url="http://www.ncbi.nlm.nih.gov/pubmed/34346900" }