Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Medical University of South Carolina649 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

649

Conditions

Depressive Symptoms Depression

Interventions

Behavioral Activation Therapy appBEHAVIORAL

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.

Behavioral Activation Therapy app + EHRBEHAVIORAL

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.

Treatment as Usual

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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?")

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Between baseline and week 12

Data from ClinicalTrials.gov

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