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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Maya app is useful and easy to use for people who are pregnant or gave birth within the past 12 months and have trouble with mood, anxiety, or stress. The app has 12 lessons that teach skills to manage mood and anxiety. Participants will track symptoms, answer surveys, and give feedback in interviews.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are carrying or have carried a pregnancy and identify as female, trans male, nonbinary, gender expansive, or questioning your gender.
  • Are pregnant now or gave birth within the past 12 months.
  • Are age 18 or older.
  • Can use English.
  • Have a smartphone or other mobile device that can receive text messages and run the study surveys and app lessons.
  • Can talk by phone or secure video call at times during the study.

Who can't join

  • Have safety concerns when joining, such as any score above zero on question 10 of the EPDS mood survey, or thoughts or acts of suicide or self-harm within the past year.
  • Currently have a substance use disorder, meaning alcohol or drug use that causes problems.
  • Have ever had bipolar disorder or a psychotic disorder, or now have psychosis (trouble knowing what is real) or mania (an unusually high or irritable mood with high energy).

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY