- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04463914
Evaluation of a Mobile Therapy for Elevated Depressive Symptoms
March 4, 2024 updated by: Jennifer Dahne, Medical University of South Carolina
Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms
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 Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Estimated)
650
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group A- 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.
|
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.
|
Experimental: Group B- Moodivate
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.
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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.
|
Experimental: Group C- Moodivate + 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Score of Depressive Symptoms
Time Frame: Between baseline and week 12
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jennifer Dahne, PhD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2021
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
July 31, 2024
Study Registration Dates
First Submitted
July 6, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00096156
- 5R42MH108219-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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