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

NCT ID: NCT05897619

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2026-08-31

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.

Detailed Description

Individuals who are pregnant or postpartum are at a high risk of anxiety and mood difficulties. This has been linked to negative effects on the individual, developing baby (both in the womb and after birth), and family system. Despite this, there are significant barriers to getting mental health support while pregnant or as a new parent, particularly for those in disadvantaged communities. This study seeks to assess the feasibility and acceptability of a novel mobile health app among individuals who are pregnant or postpartum. The Maya Perinatal Cognitive Behavioral Skills App has been adapted from a previously studied Maya Cognitive Behavioral Skills App to specifically address the unique experiences of the perinatal population. The app includes 12 skill-based sessions using principles from cognitive behavioral therapy, an evidence-based treatment that can effectively address anxiety and mood symptoms. The app will be tested by pregnant and postpartum individuals, who will provide feedback on feasibility and acceptability. Participants will also complete screening measures assessing anxiety, mood, and trauma, which will be examined in the context of app use and engagement. Participants will be recruited from a range of settings in hopes of capturing a diverse sample in terms of race, cultural background, and financial means. Results will be used to inform future versions of the app to better suit this population.

Conditions

Perinatal Anxiety; Perinatal Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Maya Perinatal Cognitive Behavioral Skills App

Participants receive the Maya Perinatal Cognitive Behavioral Skills App for 6 weeks.

Group Type: EXPERIMENTAL

Experimental: Maya Perinatal Cognitive Behavioral Skills App

Intervention Type: BEHAVIORAL

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.

Interventions

Experimental: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Temkin-Yu, Psy.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrea Temkin-Yu, Psy.D.

Role: CONTACT

abt4002@med.cornell.edu

‪(640) 203-8301

Ace Oh, MA

Role: CONTACT

sao4008@med.cornell.edu

Facility Contacts

Andrea Temkin-Yu, Psy.D.

Role: primary

abt4002@med.cornell.edu

640-203-8301

Aliza Ayaz, B.S.

Role: backup

ala4015@med.cornell.edu

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Other Identifiers

22-10025299

Identifier Type: -

Identifier Source: org_study_id