Protocol for non-randomized pilot trial assessing feasibility of a mobile app-based cognitive-behavioral Perinatal Skills Program (Preprint)

Abstract

Mental illness is one of the top causes of preventable pregnancy-related deaths in the United States. There are many barriers that interfere with the ability of perinatal individuals to access traditional mental health care. Digital health interventions, including app-based programs, have the potential to increase access to useful tools for these individuals. Although numerous mental health apps exist, there is little research on developing programs to address the unique needs of perinatal individuals. In an effort to fill this gap, a multidisciplinary team of experts in psychology, psychiatry, obstetrics, and pediatric primary care collaborated to develop the novel Perinatal Skills Program within Maya, a flexible and customizable cognitive-behavioral skills app. Maya-Perinatal Skills Program (M-PSP) uses evidence-based strategies to help individuals manage their mood and anxiety symptoms during pregnancy and postpartum.

This pilot study aims to assess the feasibility, acceptability, and usability of M-PSP and explore links between program use and symptoms of anxiety and low mood.

This single-arm trial will recruit 50 pregnant or postpartum individuals with mild to moderate anxiety or mood symptoms. Participants will be recruited from a variety of public and private insurance-based psychiatry, obstetrics, and primary care clinics at a large academic medical center. Participants will complete all sessions of M-PSP and provide feedback. Outcome measures will include qualitative and quantitative assessments of feasibility, acceptability, and usability, passively collected program usage data, and symptom measures assessing mood, anxiety, and trauma.

Planned data analysis includes the use of the Grounded Theory Approach to identify common themes in qualitative feedback, as well as an exploration of possible associations between quantitative data regarding program use and symptoms.

Digital health interventions, like M-PSP, have the potential to create new pathways to reach individuals struggling with their mental health. The results of this study will inform future iterations of M-PSP in the hopes of providing an accessible and helpful tool for pregnant and postpartum individuals.

The study has been registered at ClinicalTrials.gov under the protocol number NCT05897619. Registered 9 June 2023, https://classic.clinicaltrials.gov/ct2/show/NCT05897619?term=NCT05897619&draw=2&rank=1