Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Not Applicable

Completed

• Conditions: Depressive Symptoms; Depression

• Registration Number: NCT04463914
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The purpose of this research study is to evaluate a mobile application (app) for depression treatment. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Study Start: 2021-10-12
• Primary Completion: 2024-01-04
• Study Completion: 2024-03-29
• Status Verified: 2024-10
• Results First Submitted: 2024-10-24
• Results First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Results First Posted: 2024-11-19
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

• Elevated depressive symptoms, defined as a score of > 10 on the Patient Health Questionnaire-9 (PHQ-9)57
• Age 18+
• Currently own an iOS- or Android-compatible smartphone
• Report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
• Have a current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments)
• Enrolled in Epic's MyChart program
• English fluency

Exclusion Criteria

• Current suicidal ideation at study screening, defined as a response >1 (several days) on item nine of the PHQ-9 ("Over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Score of Depressive Symptoms	Between baseline and week 12	Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States