Perinatal Depression Clinical Trial
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04594525 -
Maternal Telemental Health Interventions in Response to Covid-19*
|
N/A | |
Completed |
NCT04846504 -
Accelerating Implementation of Mindful Mood Balance for Moms
|
N/A | |
Not yet recruiting |
NCT05175755 -
Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
|
N/A | |
Enrolling by invitation |
NCT04517981 -
Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
|
||
Completed |
NCT04094870 -
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
|
Phase 4 | |
Completed |
NCT03291600 -
Virtual Psychiatric Care for Perinatal Depression
|
N/A | |
Completed |
NCT03938350 -
Dialectical Behavior Therapy for Pregnant Women
|
N/A | |
Active, not recruiting |
NCT04300894 -
"Mamma Mia" for Perinatal Health and Wellness
|
N/A | |
Recruiting |
NCT05595486 -
Baby2Home (B2H) Mobile Health Application
|
N/A | |
Completed |
NCT03336541 -
Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression
|
Phase 4 | |
Active, not recruiting |
NCT05393479 -
"Thinking Healthy Programme" for Perinatal Depression in Nepal
|
N/A | |
Completed |
NCT05463926 -
Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period
|
N/A | |
Completed |
NCT05119062 -
The Feasibility of an Online Intergenerational Co-parenting Program
|
N/A | |
Enrolling by invitation |
NCT04838210 -
Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
|
N/A | |
Not yet recruiting |
NCT06405932 -
Study of the Intervention Effect of Self-help Training Camps in Promoting Mental Health Among Perinatal Women
|
N/A | |
Not yet recruiting |
NCT06383221 -
Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy.
|
N/A | |
Not yet recruiting |
NCT06364488 -
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
|
N/A | |
Completed |
NCT03932760 -
Telehealth Group Intervention for Perinatal Depressive Symptoms
|
N/A | |
Active, not recruiting |
NCT05196152 -
MomMoodBooster VA Program
|
N/A | |
Completed |
NCT02935504 -
PRogram In Support of Moms (PRISM): A Pilot Study
|
N/A |