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

NCT05897619 | Recruiting

• 1 other identifier: 22-10025299
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Anxiety; Perinatal Depression

Keywords

Perinatal; Pregnancy; Postpartum; Perinatal Mood and Anxiety Disorders; Cognitive Behavioral Therapy; Mobile App; mobile Health (mHealth)

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (19)

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

  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).

  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).

  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).

  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).

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

Study Arms (1)

Maya Perinatal Cognitive Behavioral Skills App

EXPERIMENTAL

Participants receive the Maya Perinatal Cognitive Behavioral Skills App for 6 weeks.

Behavioral: Experimental: Maya Perinatal Cognitive Behavioral Skills App

Interventions

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.

Maya Perinatal Cognitive Behavioral Skills App

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, Trans-male, non-binary, gender expansive, or gender questioning gestational carriers of pregnancy
• Currently pregnant or up to 12 months postpartum
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

Related Publications (15)

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  PMID: 15051562 BACKGROUND

• Dennis CL, Chung-Lee L. Postpartum depression help-seeking barriers and maternal treatment preferences: a qualitative systematic review. Birth. 2006 Dec;33(4):323-31. doi: 10.1111/j.1523-536X.2006.00130.x.

  PMID: 17150072 BACKGROUND

• Furtado M, Chow CHT, Owais S, Frey BN, Van Lieshout RJ. Risk factors of new onset anxiety and anxiety exacerbation in the perinatal period: A systematic review and meta-analysis. J Affect Disord. 2018 Oct 1;238:626-635. doi: 10.1016/j.jad.2018.05.073. Epub 2018 Jun 18.

  PMID: 29957480 BACKGROUND

• Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

  PMID: 16260528 BACKGROUND

• Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.

  PMID: 15760246 BACKGROUND

• Goodman SH, Gotlib IH. Risk for psychopathology in the children of depressed mothers: a developmental model for understanding mechanisms of transmission. Psychol Rev. 1999 Jul;106(3):458-90. doi: 10.1037/0033-295x.106.3.458.

  PMID: 10467895 BACKGROUND

• Gjerdingen DK, Yawn BP. Postpartum depression screening: importance, methods, barriers, and recommendations for practice. J Am Board Fam Med. 2007 May-Jun;20(3):280-8. doi: 10.3122/jabfm.2007.03.060171.

  PMID: 17478661 BACKGROUND

• Murray L. The impact of postnatal depression on infant development. J Child Psychol Psychiatry. 1992 Mar;33(3):543-61. doi: 10.1111/j.1469-7610.1992.tb00890.x.

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  PMID: 19318144 BACKGROUND

• Slomian J, Honvo G, Emonts P, Reginster JY, Bruyere O. Consequences of maternal postpartum depression: A systematic review of maternal and infant outcomes. Womens Health (Lond). 2019 Jan-Dec;15:1745506519844044. doi: 10.1177/1745506519844044.

  PMID: 31035856 BACKGROUND

• Tietz A, Zietlow AL, Reck C. Maternal bonding in mothers with postpartum anxiety disorder: the crucial role of subclinical depressive symptoms and maternal avoidance behaviour. Arch Womens Ment Health. 2014 Oct;17(5):433-42. doi: 10.1007/s00737-014-0423-x. Epub 2014 Apr 1.

  PMID: 24687168 BACKGROUND

• Trost SL, Beauregard JL, Smoots AN, Ko JY, Haight SC, Moore Simas TA, Byatt N, Madni SA, Goodman D. Preventing Pregnancy-Related Mental Health Deaths: Insights From 14 US Maternal Mortality Review Committees, 2008-17. Health Aff (Millwood). 2021 Oct;40(10):1551-1559. doi: 10.1377/hlthaff.2021.00615.

  PMID: 34606354 BACKGROUND

• Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.

  PMID: 23487258 BACKGROUND

• Wisner KL, Hanusa BH, Perel JM, Peindl KS, Piontek CM, Sit DK, Findling RL, Moses-Kolko EL. Postpartum depression: a randomized trial of sertraline versus nortriptyline. J Clin Psychopharmacol. 2006 Aug;26(4):353-60. doi: 10.1097/01.jcp.0000227706.56870.dd.

  PMID: 16855451 BACKGROUND

• Temkin-Yu AB, Ayaz A, Blicker E, Liu MX, Oh A, Siegel IE, Seewald MJ, Hermann AD, Givrad S, Baez LM, Osborne LM, Green CM, Schier MM, Davis AM, Zhu S, Falk A, Bennett SM. Feasibility of a Mobile App-Based Cognitive-Behavioral Perinatal Skills Program: Protocol for Nonrandomized Pilot Trial. JMIR Res Protoc. 2025 Jan 28;14:e59461. doi: 10.2196/59461.

  PMID: 39874578 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Andrea Temkin-Yu, Psy.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Temkin-Yu, Psy.D.

CONTACT

‪(640) 203-8301; abt4002@med.cornell.edu

Gail Harrison, MA

CONTACT

gah4007@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)