Perinatal AnxietyNCT05897619
Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals
A study testing Experimental: Maya Perinatal Cognitive Behavioral Skills App in people with Perinatal Anxiety and Perinatal Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Anxiety, Perinatal Depression
- What is being tested?
- Experimental: Maya Perinatal Cognitive Behavioral Skills App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gail Harrison, MA contact
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Andrea Temkin-Yu, Psy.D., 640-203-8301, abt4002@med.cornell.edu
Gail Harrison, B.S., gah4007@med.cornell.edu
About this study
Official title: Pilot Trial Assessing Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for a Perinatal Population
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.
Read the 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.
- Conditions
- Perinatal Anxiety, Perinatal Depression
- Being tested
- Experimental: Maya Perinatal Cognitive Behavioral Skills App
- Keywords
- Perinatal, Pregnancy, Postpartum, Perinatal Mood and Anxiety Disorders, Cognitive Behavioral Therapy, Mobile App, mobile Health (mHealth)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Maya Perinatal Cognitive Behavioral Skills AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Maya Perinatal Cognitive Behavioral Skills App | Experimental | Participants receive the Maya Perinatal Cognitive Behavioral Skills App for 6 weeks. Receives: Behavioral: Experimental: Maya Perinatal Cognitive Behavioral Skills App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start19 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Temkin-Yu, Psy.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897619
- Sponsor's protocol ID
- 22-10025299
- Status last verified
- Feb 2026
- First submitted
- 1 Jun 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004 Apr;103(4):698-709. doi: 10.1097/01.AOG.0000116689.75396.5f.
PubMed 15051562Dennis 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.
PubMed 17150072Furtado 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.
PubMed 29957480Gavin 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.
PubMed 16260528Gaynes 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.
PubMed 15760246Goodman 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.
PubMed 10467895Gjerdingen 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.
PubMed 17478661Murray 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.
PubMed 1577898Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.
PubMed 19318144Slomian 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.
PubMed 31035856Tietz 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.
PubMed 24687168Trost 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.
PubMed 34606354Wisner 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.
PubMed 23487258Wisner 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.
PubMed 16855451Temkin-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.
PubMed 39874578
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Assessing Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for a Perinatal Population
- ClinicalTrials.gov ID
- NCT05897619
- Acronym / sponsor ID
- 22-10025299
- Conditions
- Perinatal Anxiety, Perinatal Depression
- Keywords
- Perinatal, Pregnancy, Postpartum, Perinatal Mood and Anxiety Disorders, Cognitive Behavioral Therapy, Mobile App, mobile Health (mHealth)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maya Perinatal Cognitive Behavioral Skills App | Experimental | Behavioral: Experimental: Maya Perinatal Cognitive Behavioral Skills AppParticipants receive the Maya Perinatal Cognitive Behavioral Skills App for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Maya Perinatal Cognitive Behavioral Skills AppThe 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. | Behavioural | Maya Perinatal Cognitive Behavioral Skills App |
Primary outcome
User Version of the Mobile Application Rating Scale (uMARS) at midpoint
Time frame: Midpoint (approximately 3 weeks)
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).
User Version of the Mobile Application Rating Scale (uMARS) at post-intervention
Time frame: Post-intervention (approximately 6 weeks)
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).
User Version of the Mobile Application Rating Scale (uMARS) at follow-up
Time frame: Follow-up (approximately 12 weeks)
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).
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 1 (approximately week 1)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 2 (approximately week 1)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 3 (approximately week 2)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 4 (approximately week 2)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 5 (approximately week 3)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 6 (approximately week 3)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 7 (approximately week 4)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 8 (approximately week 4)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 9 (approximately week 5)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 10 (approximately week 5)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 11 (approximately week 6)
Self-report measures asking for qualitative feedback on module content and user experience.
Quantitative Feedback Survey of App Feasibility and Acceptability
Time frame: Module 12 (approximately week 6)
Self-report measures asking for qualitative feedback on module content and user experience.
Qualitative Feedback of App Feasibility and Acceptability at midpoint
Time frame: Midpoint (approximately 3 weeks)
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.
Qualitative Feedback of App Feasibility and Acceptability at post-intervention
Time frame: Post-intervention (approximately 6 weeks)
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.
Qualitative Feedback of App Feasibility and Acceptability at follow-up
Time frame: Follow-up (approximately 12 weeks)
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.
19 secondary outcomes
Changes in postnatal depression measures scores from baseline to midpoint as measured by the Edinburgh Postnatal Depression Scale (EPDS).
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).
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).
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).
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).
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).
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).
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).
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: Post-intervention (approximately 6 weeks), follow-up (approximately 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 15051562Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004 Apr;103(4):698-709. doi: 10.1097/01.AOG.0000116689.75396.5f.
- Background: PubMed 17150072Dennis 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.
- Background: PubMed 29957480Furtado 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.
- Background: PubMed 16260528Gavin 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.
- Background: PubMed 15760246Gaynes 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.
- Background: PubMed 10467895Goodman 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.
- Background: PubMed 17478661Gjerdingen 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.
- Background: PubMed 1577898Murray 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.
- Background: PubMed 19318144Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.
- Background: PubMed 31035856Slomian 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.
- Background: PubMed 24687168Tietz 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.
- Background: PubMed 34606354Trost 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gail Harrison, MA contact
Andrea Temkin-Yu, Psy.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Maya Perinatal Cognitive Behavioral Skills App in people with Perinatal Anxiety and Perinatal Depression, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Temkin-Yu, Psy.D. ((640) 203-8301, abt4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Version of the Mobile Application Rating Scale (uMARS) at midpoint (time frame: Midpoint (approximately 3 weeks)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897619, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.