Clinical trial NCT05897619: Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals
Official title: Pilot Trial Assessing Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for a Perinatal Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Anxiety
Perinatal Depression
Keywords: Perinatal
Pregnancy
Postpartum
Perinatal Mood and Anxiety Disorders
Cognitive Behavioral Therapy
Mobile App
mobile Health (mHealth)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

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.

Primary outcomes:
measure: User Version of the Mobile Application Rating Scale (uMARS) at midpoint
timeFrame: Midpoint (approximately 3 weeks)
measure: User Version of the Mobile Application Rating Scale (uMARS) at post-intervention
timeFrame: Post-intervention (approximately 6 weeks)
measure: User Version of the Mobile Application Rating Scale (uMARS) at follow-up
timeFrame: Follow-up (approximately 12 weeks)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 1 (approximately week 1)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 2 (approximately week 1)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 3 (approximately week 2)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 4 (approximately week 2)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 5 (approximately week 3)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 6 (approximately week 3)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 7 (approximately week 4)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 8 (approximately week 4)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 9 (approximately week 5)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 10 (approximately week 5)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 11 (approximately week 6)
measure: Quantitative Feedback Survey of App Feasibility and Acceptability
timeFrame: Module 12 (approximately week 6)
measure: Qualitative Feedback of App Feasibility and Acceptability at midpoint
timeFrame: Midpoint (approximately 3 weeks)
measure: Qualitative Feedback of App Feasibility and Acceptability at post-intervention
timeFrame: Post-intervention (approximately 6 weeks)
measure: Qualitative Feedback of App Feasibility and Acceptability at follow-up
timeFrame: Follow-up (approximately 12 weeks)
Secondary outcomes:
measure: Changes in postnatal depression measures scores from baseline to midpoint as measured by the Edinburgh Postnatal Depression Scale (EPDS).
timeFrame: Baseline, midpoint (approximately 3 weeks)
measure: Changes in postnatal depression measures scores from baseline to post-intervention as measured by the Edinburgh Postnatal Depression Scale (EPDS).
timeFrame: Baseline, post-intervention (approximately 6 weeks)
measure: Changes in postnatal depression measures scores from midpoint to post-intervention as measured by the Edinburgh Postnatal Depression Scale (EPDS).
timeFrame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)
measure: Changes in postnatal depression measures scores from post-intervention to follow-up as measured by the Edinburgh Postnatal Depression Scale (EPDS).
timeFrame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks).
measure: Changes in postnatal anxiety measures scores from baseline to midpoint as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
timeFrame: To be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.
measure: Changes in postnatal anxiety measures scores from baseline to post-intervention as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
timeFrame: Baseline, post-intervention (approximately 6 weeks)
measure: Changes in postnatal anxiety measures scores from midpoint to post-intervention as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
timeFrame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)
measure: Changes in postnatal anxiety measures scores from post-intervention to follow-up as measured by the Edinburgh Postnatal Depression Scale-Anxiety Subscale (EPDS 3A).
timeFrame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)
measure: Changes in anxiety measures scores from baseline to midpoint as measured by the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, midpoint (approximately 3 weeks)
measure: Changes in anxiety measures scores from baseline to post-intervention as measured by the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, post-intervention (approximately 6 weeks)
measure: Changes in anxiety measures scores from midpoint to post-intervention as measured by the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Midpoint (approximately 3 weeks), post-intervention (approximately 6 weeks)
measure: Changes in anxiety measures scores from post-intervention to follow-up as measured by the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)
measure: Change in depression measures scores from baseline to midpoint as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, midpoint (approximately 3 weeks)
measure: Change in depression measures scores from baseline to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, post-intervention (approximately 6 weeks)
measure: Change in depression measures scores from midpoint to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Midpoint, post-intervention (approximately 6 weeks)
measure: Change in depression measures scores from post-intervention to follow-up as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Post-intervention (approximately 6 weeks), Follow-up (approximately 12 weeks)
measure: Changes in perinatal trauma measure scores from baseline to post-intervention as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)
timeFrame: To be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.
measure: Changes in perinatal trauma measure scores from baseline to post-intervention as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)
timeFrame: Baseline, post-intervention (approximately 6 weeks)
measure: Changes in perinatal trauma measure scores from post-intervention to follow-up as measured by Perinatal-Post Traumatic Stress Disorder Questionnaire-II (PPQ-II)
timeFrame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Andrea Temkin-Yu, Psy.D.
role: PRINCIPAL_INVESTIGATOR
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