Smartphone Delivery of Cognitive Behavioral Therapy for Post-intensive Care Syndrome-Family: A Pilot Study (Preprint)
BACKGROUND Family members of critically ill patients suffer symptoms of post-intensive care syndrome-family (PICS-F), including anxiety, depression, and post-traumatic stress disorder. Post-intensive care syndrome-family reduces the quality of life of the families of critically ill patients and may impede recovery of the patient. Cognitive behavioral therapy has become a first-line non-pharmacological treatment of psychological symptoms and disorders, including anxiety, depression, and post-traumatic stress. For mild-to-moderate symptoms, mobile technology delivery of cognitive behavioral therapy without input from a clinician has been found to be feasible and well-accepted with efficacy that rivals face-to-face therapy. OBJECTIVE The purpose of this pilot study is to examine the efficacy of smartphone delivery of cognitive behavioral therapy via a mobile health app on the severity and prevalence of PICS-F symptoms in family members of critically ill patients. METHODS For this pilot study, 60 family members of critically ill patients will be recruited. A repeated measures longitudinal design with randomization to two groups (control, intervention) will be employed. The intervention group will receive cognitive behavioral therapy delivered via a smartphone mobile health app. Bandura’s Social Cognition Theory with an emphasis on mental health self-efficacy forms the theoretical framework of the study. RESULTS Recruitment for the study began in August, 2020. Data collection and analysis is expected to be completed by March, 2022. Primary outcome measures will include symptoms of PICS-F (anxiety, depression, post-traumatic stress), health-related quality of life, and mental health self-efficacy measured at enrollment, 30 days after enrollment, and 60 days after enrollment. CONCLUSIONS The proposed study represents a novel approach to the treatment of PICS-F symptoms, is an extension of previous work by the research team, and will be used to plan a fully powered, randomized, controlled trial. CLINICALTRIAL ClinicalTrials.gov NCT04316767; https://clinicaltrials.gov/ct2/show/NCT04316767?cond=Post-Intensive+Care+Syndrome&draw=3&rank=17