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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
Weill Cornell Medical College
New York, New York, United States
RECRUITINGUser Version of the Mobile Application Rating Scale (uMARS) at midpoint
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).
Time frame: Midpoint (approximately 3 weeks)
User Version of the Mobile Application Rating Scale (uMARS) at post-intervention
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).
Time frame: Post-intervention (approximately 6 weeks)
User Version of the Mobile Application Rating Scale (uMARS) at follow-up
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).
Time frame: Follow-up (approximately 12 weeks)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 1 (approximately week 1)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 2 (approximately week 1)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 3 (approximately week 2)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 4 (approximately week 2)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 5 (approximately week 3)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 6 (approximately week 3)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 7 (approximately week 4)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 8 (approximately week 4)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 9 (approximately week 5)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 10 (approximately week 5)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 11 (approximately week 6)
Quantitative Feedback Survey of App Feasibility and Acceptability
Self-report measures asking for qualitative feedback on module content and user experience.
Time frame: Module 12 (approximately week 6)
Qualitative Feedback of App Feasibility and Acceptability at midpoint
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.
Time frame: Midpoint (approximately 3 weeks)
Qualitative Feedback of App Feasibility and Acceptability at post-intervention
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.
Time frame: Post-intervention (approximately 6 weeks)
Qualitative Feedback of App Feasibility and Acceptability at follow-up
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.
Time frame: Follow-up (approximately 12 weeks)
Changes in postnatal depression measures scores from baseline to midpoint as measured by the Edinburgh Postnatal Depression Scale (EPDS).
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).
Time frame: Baseline, midpoint (approximately 3 weeks)
Changes in postnatal depression measures scores from baseline to post-intervention as measured by the Edinburgh Postnatal Depression Scale (EPDS).
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).
Time frame: Baseline, post-intervention (approximately 6 weeks)
Changes in postnatal depression measures scores from midpoint to post-intervention as measured by the Edinburgh Postnatal Depression Scale (EPDS).
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).
Time frame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)
Changes in postnatal depression measures scores from post-intervention to follow-up as measured by the Edinburgh Postnatal Depression Scale (EPDS).
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).
Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks).
Changes in postnatal anxiety measures scores from baseline to midpoint as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: To be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.
Changes in postnatal anxiety measures scores from baseline to post-intervention as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
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.
Time frame: Baseline, post-intervention (approximately 6 weeks)
Changes in postnatal anxiety measures scores from midpoint to post-intervention as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
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.
Time frame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)
Changes in postnatal anxiety measures scores from post-intervention to follow-up as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
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.
Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)
Changes in anxiety measures scores from baseline to midpoint as measured by the Generalized Anxiety Disorder-7 (GAD-7)
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).
Time frame: Baseline, midpoint (approximately 3 weeks)
Changes in anxiety measures scores from baseline to post-intervention as measured by the Generalized Anxiety Disorder-7 (GAD-7)
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)
Time frame: Baseline, post-intervention (approximately 6 weeks)
Changes in anxiety measures scores from midpoint to post-intervention as measured by the Generalized Anxiety Disorder-7 (GAD-7)
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)
Time frame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)
Changes in anxiety measures scores from post-intervention to follow-up as measured by the Generalized Anxiety Disorder-7 (GAD-7)
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)
Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)
Change in depression measures scores from baseline to midpoint as measured by the Patient Health Questionnaire-9 (PHQ-9)
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).
Time frame: Baseline, midpoint (approximately 3 weeks)
Change in depression measures scores from baseline to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)
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).
Time frame: Baseline, post-intervention (approximately 6 weeks)
Change in depression measures scores from midpoint to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)
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).
Time frame: Midpoint, post-intervention (approximately 6 weeks)
Change in depression measures scores from post-intervention to follow-up as measured by the Patient Health Questionnaire-9 (PHQ-9)
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).
Time frame: Post-intervention (approximately 6 weeks), Follow-up (approximately 12 weeks)
Changes in perinatal trauma measure scores from baseline to post-intervention as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)
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.
Time frame: To be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.
Changes in perinatal trauma measure scores from baseline to post-intervention as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)
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.
Time frame: Baseline, post-intervention (approximately 6 weeks)
Changes in perinatal trauma measure scores from post-intervention to follow-up as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)
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.
Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)