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

Perinatal Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897619
• Other study ID #: 22-10025299
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Weill Medical College of Cornell University
• Contact: Andrea Temkin-Yu, Psy.D.
• Phone: ?(640) 203-8301
• Email: abt4002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Perinatal Anxiety
• Perinatal Depression

Intervention

Behavioral:
• Experimental: Maya Perinatal Cognitive Behavioral Skills App
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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. Erratum In: Obstet Gynecol. 2004 Jun;103(6):1344. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pearlstein 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. — View Citation

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. Erratum In: Womens Health (Lond). 2019 Jan-Dec;15:1745506519854864. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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).
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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.
Secondary	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)
Secondary	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)