Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Study 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.

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

Conditions
-----------------
Depressive Symptoms, Depression

Intervention / Treatment
-----------------
* Behavioral: Behavioral Activation Therapy app
* Behavioral: Behavioral Activation Therapy app + EHR
* Behavioral: Treatment as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
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?)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A- Treatment as Usual<br>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. | Behavioral: Treatment as Usual<br>* Participants 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.<br>|
| Experimental: Group B- Moodivate<br>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. | Behavioral: Behavioral Activation Therapy app<br>* Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.<br>|
| Experimental: Group C- Moodivate + EHR<br>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. | Behavioral: Behavioral Activation Therapy app + EHR<br>* Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. The participant's primary care provider at MUSC will be provided access to a Moodivate provider portal that was developed by study team. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Score of Depressive Symptoms | 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. | Between baseline and week 12 |