NCT04463914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
649

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 19, 2024

Completed
Last Updated

November 19, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

July 6, 2020

Results QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Depressive SymptomsDepression

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group A- Treatment as Usual

OTHER

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

Group B- Moodivate

EXPERIMENTAL

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

Group C- Moodivate + EHR

EXPERIMENTAL

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

Interventions

Behavioral Activation Therapy appBEHAVIORAL

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.

Group B- Moodivate
Behavioral Activation Therapy app + EHRBEHAVIORAL

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.

Group C- Moodivate + EHR
Treatment as UsualBEHAVIORAL

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.

Group A- Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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?")

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Dahne J, Wahlquist AE, Carpenter MJ, Graboyes EM, Lejuez CW, Kustanowitz J, Natale N, Levins O, Player M, Diaz VA. A Digital Depression Treatment Program for Adults Treated in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):692-701. doi: 10.1001/jamainternmed.2025.0494.

    PMID: 40227715DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Jennifer Dahne
Organization
Medical University of South Carolina
dahne@musc.edu
843-876-2280

Study Officials

  • Jennifer Dahne, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 9, 2020

Study Start

October 12, 2021

Primary Completion

January 4, 2024

Study Completion

March 29, 2024

Last Updated

November 19, 2024

Results First Posted

November 19, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)