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NCT Number: NCT05897619

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

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.

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Key information

Conditions

Perinatal Anxiety Anxiety Disorders Mental Disorders Perinatal Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10065, United States

Location status: Recruiting

Location contact

Andrea Temkin-Yu, Psy.D.

CONTACT

[email protected]

640-203-8301

Andrea Temkin-Yu, Psy.D.

PRINCIPAL_INVESTIGATOR

Gail Harrison, B.S.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Maya Perinatal Cognitive Behavioral Skills App

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.

Primary outcomes

  1. User Version of the Mobile Application Rating Scale (uMARS) at midpoint

    Time frame: Midpoint (approximately 3 weeks)

    The uMARS is a 27-item self-report questionnaire assessing engagement, functionality, aesthetics, information, subjective quality, and perceived impact of an app. Total scores are calculated by averaging the items together, representing an overall perceived app quality score ranging from 1 (inadequate) to 5 (excellent).

  2. User Version of the Mobile Application Rating Scale (uMARS) at post-intervention

    Time frame: Post-intervention (approximately 6 weeks)

    The uMARS is a 27-item self-report questionnaire assessing engagement, functionality, aesthetics, information, subjective quality, and perceived impact of an app. Total scores are calculated by averaging the items together, representing an overall perceived app quality score ranging from 1 (inadequate) to 5 (excellent).

  3. User Version of the Mobile Application Rating Scale (uMARS) at follow-up

    Time frame: Follow-up (approximately 12 weeks)

    The uMARS is a 27-item self-report questionnaire assessing engagement, functionality, aesthetics, information, subjective quality, and perceived impact of an app. Total scores are calculated by averaging the items together, representing an overall perceived app quality score ranging from 1 (inadequate) to 5 (excellent).

  4. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 1 (approximately week 1)

    Self-report measures asking for qualitative feedback on module content and user experience.

  5. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 2 (approximately week 1)

    Self-report measures asking for qualitative feedback on module content and user experience.

  6. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 3 (approximately week 2)

    Self-report measures asking for qualitative feedback on module content and user experience.

  7. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 4 (approximately week 2)

    Self-report measures asking for qualitative feedback on module content and user experience.

  8. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 5 (approximately week 3)

    Self-report measures asking for qualitative feedback on module content and user experience.

  9. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 6 (approximately week 3)

    Self-report measures asking for qualitative feedback on module content and user experience.

  10. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 7 (approximately week 4)

    Self-report measures asking for qualitative feedback on module content and user experience.

  11. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 8 (approximately week 4)

    Self-report measures asking for qualitative feedback on module content and user experience.

  12. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 9 (approximately week 5)

    Self-report measures asking for qualitative feedback on module content and user experience.

  13. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 10 (approximately week 5)

    Self-report measures asking for qualitative feedback on module content and user experience.

  14. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 11 (approximately week 6)

    Self-report measures asking for qualitative feedback on module content and user experience.

  15. Quantitative Feedback Survey of App Feasibility and Acceptability

    Time frame: Module 12 (approximately week 6)

    Self-report measures asking for qualitative feedback on module content and user experience.

  16. Qualitative Feedback of App Feasibility and Acceptability at midpoint

    Time frame: Midpoint (approximately 3 weeks)

    Feedback Interviews are qualitative interview-based questionnaires that a member of the research team will lead during a phone or video call with each participant. Items will examine participant response to app content, structure, and functionality, as well as engagement and satisfaction.

  17. Qualitative Feedback of App Feasibility and Acceptability at post-intervention

    Time frame: Post-intervention (approximately 6 weeks)

    Feedback Interviews are qualitative interview-based questionnaires that a member of the research team will lead during a phone or video call with each participant. Items will examine participant response to app content, structure, and functionality, as well as engagement and satisfaction.

  18. Qualitative Feedback of App Feasibility and Acceptability at follow-up

    Time frame: Follow-up (approximately 12 weeks)

    Feedback Interviews are qualitative interview-based questionnaires that a member of the research team will lead during a phone or video call with each participant. Items will examine participant response to app content, structure, and functionality, as well as engagement and satisfaction.

Secondary outcomes

  1. Changes in postnatal depression measures scores from baseline to midpoint as measured by the Edinburgh Postnatal Depression Scale (EPDS).

    Time frame: Baseline, midpoint (approximately 3 weeks)

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. Scores range from 0 to 30 with the following interpretation: 0-7 (depression not likely), 8-13 (depression possible), 14+ (depression probable).

  2. Changes in postnatal depression measures scores from baseline to post-intervention as measured by the Edinburgh Postnatal Depression Scale (EPDS).

    Time frame: Baseline, post-intervention (approximately 6 weeks)

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. Scores range from 0 to 30 with the following interpretation: 0-7 (depression not likely), 8-13 (depression possible), 14+ (depression probable).

  3. Changes in postnatal depression measures scores from midpoint to post-intervention as measured by the Edinburgh Postnatal Depression Scale (EPDS).

    Time frame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. Scores range from 0 to 30 with the following interpretation: 0-7 (depression not likely), 8-13 (depression possible), 14+ (depression probable).

  4. Changes in postnatal depression measures scores from post-intervention to follow-up as measured by the Edinburgh Postnatal Depression Scale (EPDS).

    Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks).

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. Scores range from 0 to 30 with the following interpretation: 0-7 (depression not likely), 8-13 (depression possible), 14+ (depression probable).

  5. Changes in postnatal anxiety measures scores from baseline to midpoint as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).

    Time frame: To be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. The Edinburgh Anxiety Subscale (EPDS 3A) uses three items from the EPDS to assess levels of anxiety among perinatal individuals. Scores range from 0 to 9, with scores of 6+ indicating likely anxiety.

  6. Changes in postnatal anxiety measures scores from baseline to post-intervention as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).

    Time frame: Baseline, post-intervention (approximately 6 weeks)

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. The Edinburgh Anxiety Subscale (EPDS 3A) uses three items from the EPDS to assess levels of anxiety among perinatal individuals. Scores range from 0 to 9, with scores of 6+ indicating likely anxiety.

  7. Changes in postnatal anxiety measures scores from midpoint to post-intervention as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).

    Time frame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. The Edinburgh Anxiety Subscale (EPDS 3A) uses three items from the EPDS to assess levels of anxiety among perinatal individuals. Scores range from 0 to 9, with scores of 6+ indicating likely anxiety.

  8. Changes in postnatal anxiety measures scores from post-intervention to follow-up as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).

    Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure of mood symptoms in perinatal individuals. The Edinburgh Anxiety Subscale (EPDS 3A) uses three items from the EPDS to assess levels of anxiety among perinatal individuals. Scores range from 0 to 9, with scores of 6+ indicating likely anxiety.

  9. Changes in anxiety measures scores from baseline to midpoint as measured by the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, midpoint (approximately 3 weeks)

    The General Anxiety Disorder-7 is a 7 item self-report measure assessing symptoms of anxiety. Scores range from 0 to 21 with the following interpretation: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety).

  10. Changes in anxiety measures scores from baseline to post-intervention as measured by the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, post-intervention (approximately 6 weeks)

    The General Anxiety Disorder-7 is a 7 item self-report measure assessing symptoms of anxiety. Scores range from 0 to 21 with the following interpretation: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety)

  11. Changes in anxiety measures scores from midpoint to post-intervention as measured by the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)

    The General Anxiety Disorder-7 is a 7 item self-report measure assessing symptoms of anxiety. Scores range from 0 to 21 with the following interpretation: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety)

  12. Changes in anxiety measures scores from post-intervention to follow-up as measured by the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)

    The General Anxiety Disorder-7 is a 7 item self-report measure assessing symptoms of anxiety. Scores range from 0 to 21 with the following interpretation: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety)

  13. Change in depression measures scores from baseline to midpoint as measured by the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, midpoint (approximately 3 weeks)

    The PHQ-9 is a 9 item self-report measure assessing symptoms of depression. Scores range from 0 to 27 with the following interpretation: 1-4 (minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), 20-27 (severe depression).

  14. Change in depression measures scores from baseline to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, post-intervention (approximately 6 weeks)

    The PHQ-9 is a 9 item self-report measure assessing symptoms of depression. Scores range from 0 to 27 with the following interpretation: 1-4 (minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), 20-27 (severe depression).

  15. Change in depression measures scores from midpoint to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Midpoint, post-intervention (approximately 6 weeks)

    The PHQ-9 is a 9 item self-report measure assessing symptoms of depression. Scores range from 0 to 27 with the following interpretation: 1-4 (minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), 20-27 (severe depression).

  16. Change in depression measures scores from post-intervention to follow-up as measured by the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Post-intervention (approximately 6 weeks), Follow-up (approximately 12 weeks)

    The PHQ-9 is a 9 item self-report measure assessing symptoms of depression. Scores range from 0 to 27 with the following interpretation: 1-4 (minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), 20-27 (severe depression).

  17. Changes in perinatal trauma measure scores from baseline to post-intervention as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)

    Time frame: To be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.

    The Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II) is a 14-item self-report measure assessing symptoms of trauma among postpartum individuals. Scores range from 0 to 56, with scores of 19+ distinguishing individuals in need of treatment to address symptoms.

  18. Changes in perinatal trauma measure scores from baseline to post-intervention as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)

    Time frame: Baseline, post-intervention (approximately 6 weeks)

    The Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II) is a 14-item self-report measure assessing symptoms of trauma among postpartum individuals. Scores range from 0 to 56, with scores of 19+ distinguishing individuals in need of treatment to address symptoms.

  19. Changes in perinatal trauma measure scores from post-intervention to follow-up as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)

    Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)

    The Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II) is a 14-item self-report measure assessing symptoms of trauma among postpartum individuals. Scores range from 0 to 56, with scores of 19+ distinguishing individuals in need of treatment to address symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Temkin-Yu, Psy.D.

CONTACT

[email protected]

‪(640) 203-8301

Gail Harrison, MA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 9, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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