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

Overview

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.

Interventions

• 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.

Primary outcome measures

• User Version of the Mobile Application Rating Scale (uMARS) at midpoint [Time frame: Midpoint (approximately 3 weeks)]
• User Version of the Mobile Application Rating Scale (uMARS) at post-intervention [Time frame: Post-intervention (approximately 6 weeks)]
• User Version of the Mobile Application Rating Scale (uMARS) at follow-up [Time frame: Follow-up (approximately 12 weeks)]
• Quantitative Feedback Survey of App Feasibility and Acceptability [Time frame: Module 1 (approximately week 1)]
• Quantitative Feedback Survey of App Feasibility and Acceptability [Time frame: Module 2 (approximately week 1)]
• Quantitative Feedback Survey of App Feasibility and Acceptability [Time frame: Module 3 (approximately week 2)]
• Quantitative Feedback Survey of App Feasibility and Acceptability [Time frame: Module 4 (approximately week 2)]
• Quantitative Feedback Survey of App Feasibility and Acceptability [Time frame: Module 5 (approximately week 3)]
• Quantitative Feedback Survey of App Feasibility and Acceptability [Time frame: Module 6 (approximately week 3)]
• Quantitative Feedback Survey of App Feasibility and Acceptability [Time frame: Module 7 (approximately week 4)]

Secondary outcome measures (12)

• 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Weill Cornell Medical College — New York

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. PMID 15051562
• 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
• 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
• 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
• 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
• 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
• 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
• 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. PMID 1577898

Identifiers

NCT: NCT05897619 · 22-10025299

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗