Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

Sponsor
Medical University of South Carolina (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04463914
Collaborator
National Institutes of Health (NIH) (NIH)
650
Enrollment
1
Location
3
Arms
18.6
Anticipated Duration (Months)
35
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Behavioral Activation Therapy app
  • Behavioral: Behavioral Activation Therapy app + EHR
  • Behavioral: Treatment as Usual
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
650 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms
Actual Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

ArmIntervention/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.

Behavioral: 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.

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.

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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Mean Score of Depressive Symptoms [Between baseline and week 12]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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?")

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425

Sponsors and Collaborators

  • Medical University of South Carolina
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jennifer Dahne, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Dahne, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT04463914
Other Study ID Numbers:
  • 00096156
First Posted:
Jul 9, 2020
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021