Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04463914
• Other study ID #: 00096156
• Secondary ID: 5R42MH108219-04
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 650
• Est. completion date: September 30, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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?")

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Behavioral Activation Therapy app
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 + EHR
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
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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