Smartphone Delivery of Cognitive Behavioral Therapy for Postintensive Care Syndrome-Family: Protocol for a Pilot Study

Abstract

BackgroundFamily 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. ObjectiveThe 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. MethodsFor 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. ResultsRecruitment for the study began in August 2020. Data collection and analysis are expected to be completed by March 2022. ConclusionsThe 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 RegistrationClinicalTrials.gov NCT04316767; https://clinicaltrials.gov/ct2/show/NCT04316767 International Registered Report Identifier (IRRID)DERR1-10.2196/30813