RecruitingNot ApplicableNCT05897619

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

Pilot Trial Assessing Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for a Perinatal Population


Sponsor

Weill Medical College of Cornell University

Enrollment

75 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Female, Trans-male, non-binary, gender expansive, or gender questioning gestational carriers of pregnancy
  • Currently pregnant or up to 12 months postpartum
  • 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 Criteria3

  • 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.

Interventions

BEHAVIORALExperimental: Maya Perinatal Cognitive Behavioral Skills App

The intervention includes the completion of a mobile skills app teaching evidence-based strategies tailored for perinatal mood and anxiety. Modules include psychoeducation, skill information, practice exercises, and homework.


Locations(1)

Weill Cornell Medical College

New York, New York, United States

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NCT05897619


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