Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Not Applicable

Completed

Conditions: Depressive Symptoms
Depression

Interventions: Behavioral: Treatment as Usual
Behavioral: Behavioral Activation Therapy app
Behavioral: Behavioral Activation Therapy app + EHR

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

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

Arm && Interventions

Group	Intervention	Description
Group A- Treatment as Usual	Treatment as Usual	Participants in the treatment as usual group will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
Group B- Moodivate	Behavioral Activation Therapy app	Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
Group C- Moodivate + EHR	Behavioral Activation Therapy app + EHR	Participants randomized to the Moodivate + EHR condition will receive similar instructions as those randomized to Moodivate, but will also be instructed that their PCP will have access to metrics related to their app utilization and may choose to follow-up with them regarding treatment utilization and response. The PCP for each participant randomized to this condition will be provided EHR access to Moodivate metrics which will include metrics related to change in mood, frequency of app utilization, and frequency of activity completion. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.

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.

Secondary Outcome Measures