Mental Health Wellness 1 Clinical Trial
— MOMBAOfficial title:
The Momba Mobile Application-based Community
NCT number | NCT01816945 |
Other study ID # | 1207010574 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | September 2015 |
Verified date | April 2021 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators' mobile application-based community, termed Momba, will provide a bi-directional flow of information on maternal and infant mental health to traditionally underrepresented groups of mothers and their infants. The overall goal of this mobile application-based community of low-income postpartum women and infants is to increase the social support, social networks, and social capital of low-income mothers; thereby, leading to a positive change in the health behaviors, utilization of health services, and mental health status of both mothers and their infants.
Status | Completed |
Enrollment | 47 |
Est. completion date | September 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Women will be recruited in their third trimester of pregnancy from Yale-New Haven Hospital (YNHH) and followed for 8 months postpartum. - Women are eligible if they are over the age of 18, in their third trimester of pregnancy, will deliver a baby at YNHH and receive prenatal care at the Women's Center. - Meet criteria for minor or major depressive disorder. Exclusion Criteria: - Mothers are not eligible to participate if they have previously given birth - Are placing the baby for adoption - Are planning to move in the next 18 months - Are actively suicidal, psychotic or unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Yale School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Health | Improve maternal emotional health, was measured by the PHQ-9. The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that is used to assess depression severity. The scores range from 0-27. A score of 10 or higher can be indicative of a moderate - severe level of depression severity. | 12 months | |
Other | Confident Network Score | To assess the improvement maternal emotional health, the Kendler Social Support Interview was used. The Kendler Social Support Interview has scores that range from 0-5, with 5 indicating a larger social network or confidant network size. Presented below are the confident network score at 12 month follow-up. | 12 months | |
Primary | Phone Retention | To determine the potential feasibility of providing smartphones to participants and delivering and intervention through the smartphone, phone retention was measured. Phone retention was defined as the ability of participants to retain the phone over the study period. Outcome measure used was how many participants did not need a replacement phone during the study period. | 15 months | |
Primary | Test the Proper Operating and Functioning of the MOMBA Application | To Test the proper operating and functioning of the MOMBA application, the number of participants that received training was assessed. Intervention subjects were trained (together) on the operating and functions (including how to use the privacy settings) of the Momba application and the phone. The control subjects were trained (together) on how to complete the control questionnaires and how to use the phone. | Baseline | |
Secondary | Acceptability and Performance of Structured Questionnaires | To determine the acceptability and performance of structured questionnaires, the measurement is categorized into whether participants did or did not complete the 12 month follow-up interview. | 12 months |
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