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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Maya Perinatal Cognitive Behavioral Skills AppExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Midpoint (approximately 3 weeks)
2

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)
3

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)
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 1 (approximately week 1)

Secondary outcomes

1

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)
2

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)
3

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)
4

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).

Other outcomes

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