Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals
Recruiting · NCT05897619 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed across 1 US state.
- Weill Cornell Medical College - New York, New York, United States
- Weill Cornell Medical College - New York, New York, United States