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Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Primary Purpose

Depressive Symptoms, Depression

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation Therapy app
Behavioral Activation Therapy app + EHR
Treatment as Usual
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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?")

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Group A- Treatment as Usual

Group B- Moodivate

Group C- Moodivate + EHR

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2020
Last Updated
September 26, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04463914
Brief Title
Evaluation of a Mobile Therapy for Elevated Depressive Symptoms
Official Title
Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A- Treatment as Usual
Arm Type
Other
Arm 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.
Arm Title
Group B- Moodivate
Arm Type
Experimental
Arm 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.
Arm Title
Group C- Moodivate + EHR
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy app
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy app + EHR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Score of Depressive Symptoms
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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?")
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Dahne, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

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