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  5. Feasibility of a Mobile App-Based Cognitive-Behavioral Perinatal Skills Program: Protocol for Nonrandomized Pilot Trial.

Feasibility of a Mobile App-Based Cognitive-Behavioral Perinatal Skills Program: Protocol for Nonrandomized Pilot Trial.

File(s)
39874578.pdf (236.6 KB)
Permanent Link(s)
https://hdl.handle.net/1813/116825
Collections
Department of Psychiatry
Author
Temkin-Yu, A.B.
Ayaz, A.
Blicker, E.
Liu, M.X.
Oh, A.
Siegel, I.E.
Seewald, M.J.
Hermann, A.D.
Givrad, S.
Baez, L.M.
Osborne, L.M.
Green, C.M.
Schier, M.M.
Davis, A.M.
Zhu, S.
Falk, A.
Bennett, S.M.
Abstract

BACKGROUND: 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 post partum. OBJECTIVE: 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. METHODS: 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 located in New York City. 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. RESULTS: The recruitment began on August 2023. As of October 2024, a total of 32 participants have been enrolled. The recruitment will continue until 50 participants have been enrolled. CONCLUSIONS: 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 be the groundwork for future iterations of M-PSP in the hopes of providing an accessible and helpful tool for pregnant and postpartum individuals. TRIAL REGISTRATION: ClinicalTrials.gov NCT05897619; https://classic.clinicaltrials.gov/ct2/show/NCT05897619. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/59461.

Journal / Series
JMIR research protocols
Volume & Issue
14
Date Issued
1/28/25
Publisher
JMIR Publications
Keywords
Humans
•
Mobile Applications
•
Female
•
Pilot Projects
•
Pregnancy
•
Feasibility Studies
•
Cognitive Behavioral Therapy/methods
•
Perinatal Care/methods
•
Adult
•
Pregnancy Complications/psychology
•
apps
•
cognitive behavioral therapy
•
digital intervention
•
feasibility
•
mobile phones
•
perinatal mood and anxiety disorders
•
pilot trial
•
smartphones
•
WCM Library Coordinated Deposit
Related DOI
https://doi.org/10.2196/59461
Previously Published as
Temkin-Yu AB, Ayaz A, Blicker E, Liu MX, Oh A, Siegel IE, Seewald MJ, Hermann AD, Givrad S, Baez LM, Osborne LM, Green CM, Schier MM, Davis AM, Zhu S, Falk A, Bennett SM. Feasibility of a Mobile App-Based Cognitive-Behavioral Perinatal Skills Program: Protocol for Nonrandomized Pilot Trial. JMIR Res Protoc. 2025;14:e59461. Epub 20250128. doi: 10.2196/59461. PMID: 39874578; PMCID: PMC11815301.
Rights
Attribution 4.0 International
Rights URI
https://creativecommons.org/licenses/by/4.0/
Type
article

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