NCT05897619 Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals
| NCT ID | NCT05897619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Perinatal Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2023-09-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Andrea Temkin-Yu, Psy.D.
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT05897619 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Perinatal Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05897619 currently recruiting?
Yes, NCT05897619 is actively recruiting participants. Contact the research team at abt4002@med.cornell.edu for enrollment information.
Where is the NCT05897619 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05897619 clinical trial?
NCT05897619 is sponsored by Weill Medical College of Cornell University. The principal investigator is Andrea Temkin-Yu, Psy.D. at Weill Medical College of Cornell University. The trial plans to enroll 75 participants.
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