NCT02761720

Brief Summary

The Mobile Mood Tracking App study is a small randomized trial of acceptability and usability of a mobile phone mood tracking application (mobile app) among women with depressed mood in pregnancy. The study will be assessing the perceived value and usability of this tool in pregnancy over eight weeks to test whether women using this app are more likely to receive assessments and treatments of depressed mood than women not using it.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

May 3, 2016

Last Update Submit

May 3, 2016

Conditions

Mood DisordersDepression

Outcome Measures

Primary Outcomes (1)

  • Evidence of increased provider intervention for the treatment of worsening depressive symptoms confirmed by the mobile mood tracking application.

    8 weeks

Study Arms (3)

MyPennMedicine (MPM)

Participants assigned to this arm downloaded only the MyPennMedicine mobile app.

Other: No Intervention

MPM and Ginger iO

Participants assigned to this arm downloaded both the MyPennMedicine mobile app and Ginger iO mood tracking app.

Other: No Intervention

Lottery

Participants assigned to this arm downloaded both the MyPennMedicine mobile app and Ginger iO mood tracking app. They were also given a lottery incentive if they completed 70% of the daily mood ratings.

Other: No Intervention

Interventions

No InterventionOTHER
LotteryMPM and Ginger iOMyPennMedicine (MPM)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Dickens Center provides prenatal care to women with Medicaid insurance and its predominantly African American (90%). The mean age of patients receiving prenatal care is 25 years in this site.

You may qualify if:

  • Positive screening for elevated depression symptomatology (PHQ-9 score must be greater than or equal to 5.)

You may not qualify if:

  • Women with pregnancies of less than 33 weeks gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dickens Center for Women's Health at the Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Mood DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

February 1, 2015

Primary Completion

November 1, 2015

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

US(1)