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Clinical Trials/NCT04463914
NCT04463914
Completed
Not Applicable

Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms

Medical University of South Carolina1 site in 1 country649 target enrollmentOctober 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Medical University of South Carolina
Enrollment
649
Locations
1
Primary Endpoint
Mean Score of Depressive Symptoms
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2021
End Date
March 29, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Dahne

Assistant Professor

Medical University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • Elevated depressive symptoms, defined as a score of \> 10 on the Patient Health Questionnaire-9 (PHQ-9)57
  • 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?")

Outcomes

Primary Outcomes

Mean Score of Depressive Symptoms

Time Frame: 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.

Study Sites (1)

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