Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Depressive Symptoms; Depression

Treatments: Behavioral: Treatment as Usual; Behavioral: Behavioral Activation Therapy app; Behavioral: Behavioral Activation Therapy app + EHR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04463914

5R42MH108219-04 (U.S. NIH Grant/Contract)

00096156

Details and patient eligibility

About

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.

Enrollment: 649 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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?")

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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649 participants in 3 patient groups

Group A- Treatment as Usual

Other group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

Group B- Moodivate

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Activation Therapy app

Group C- Moodivate + EHR

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Activation Therapy app + EHR