Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 30, 2021
Date Accepted: Jun 8, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Smartphone Delivery of Cognitive Behavioral Therapy for Post-intensive Care Syndrome-Family: A Pilot Study
ABSTRACT
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. Clinical Trial: ClinicalTrials.gov NCT04316767; https://clinicaltrials.gov/ct2/show/NCT04316767?cond=Post-Intensive+Care+Syndrome&draw=3&rank=17
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