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Recruiting NCT05897619

Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals

Trial Parameters

Condition Perinatal Anxiety
Sponsor Weill Medical College of Cornell University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 75
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-09-19
Completion 2026-12
Interventions
Experimental: Maya Perinatal Cognitive Behavioral Skills App

Brief Summary

This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum individuals experiencing difficulties with mood, anxiety, or stress. Participants will complete the 12-module app to learn evidence-based strategies previously shown to help manage mood and anxiety. Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures. The study investigators hypothesizes that participants will find content to be helpful in developing skills to manage anxiety and mood difficulties during the perinatal period, and that the app interface, session structure, and pacing will be acceptable and feasible for this population. It is further hypothesized that increased Maya Perinatal Cognitive Behavioral Skills App use, engagement, and satisfaction will be associated with lower self-reported anxiety and mood symptoms.

Eligibility Criteria

Inclusion Criteria: * Female, Trans-male, non-binary, gender expansive, or gender questioning gestational carriers of pregnancy * Currently pregnant or up to 12 months postpartum * 18 years or older * English proficiency * Have access to a smartphone or other mobile device capable of receiving Short Message Service (SMS) pushes and complete Qualtrics surveys and App modules * Be available to speak by phone or secure video-conference platform at points throughout the study. Exclusion Criteria: * Safety concerns at the time of enrollment, including, but not limited to, a response \>0 on the EPDS question 10 or reported suicidal or self-harm thoughts or behaviors within one year of enrollment * Current substance use disorder * History of a bipolar or psychotic disorder, or current symptoms of psychosis or mania.

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