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

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