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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Perinatal Anxiety, Perinatal Depression

Intervention / Treatment
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* Behavioral: Experimental: Maya Perinatal Cognitive Behavioral Skills App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open pilot trial designed to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Therapy Skills app. All participants will receive the same intervention and provide qualitative and quantitative feedback on app use and experience to inform future iterations of the app.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maya Perinatal Cognitive Behavioral Skills App<br>Participants receive the Maya Perinatal Cognitive Behavioral Skills App for 6 weeks. | Behavioral: Experimental: Maya Perinatal Cognitive Behavioral Skills App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Follow-up (approximately 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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). | 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) | 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) | 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) | 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). | 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). | 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). | 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). | 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. | 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. | 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. | Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal, Pregnancy, Postpartum, Perinatal Mood and Anxiety Disorders, Cognitive Behavioral Therapy, Mobile App, mobile Health (mHealth)