Depression, Depressive Symptoms
Conditions
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALBehavioral 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.
BEHAVIORALTreatment 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.
Sponsors
National Institute of Mental Health (NIMH)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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?)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 212 |
| 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 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. | 216 |
| 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 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. | 221 |
| Total | 649 |
Baseline characteristics
| Characteristic | Group A- Treatment as Usual | Group B- Moodivate | Group C- Moodivate + EHR | Total |
|---|---|---|---|---|
| Age, Continuous | 45.27 years STANDARD_DEVIATION 15.83 | 44.53 years STANDARD_DEVIATION 15.04 | 44.26 years STANDARD_DEVIATION 14.84 | 44.68 years STANDARD_DEVIATION 15.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 12 Participants | 16 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 200 Participants | 204 Participants | 205 Participants | 609 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 47 Participants | 39 Participants | 137 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 11 Participants | 12 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 148 Participants | 153 Participants | 169 Participants | 470 Participants |
| Sex: Female, Male Female | 164 Participants | 163 Participants | 168 Participants | 495 Participants |
| Sex: Female, Male Male | 48 Participants | 53 Participants | 53 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 212 | 0 / 216 | 0 / 221 |
| other Total, other adverse events | 0 / 212 | 0 / 216 | 0 / 221 |
| serious Total, serious adverse events | 0 / 212 | 0 / 216 | 0 / 221 |
Outcome results
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.
Time frame: Between baseline and week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A- Treatment as Usual | Mean Score of Depressive Symptoms | -5.95 score on a scale | Standard Deviation 11.61 |
| Group B- Moodivate | Mean Score of Depressive Symptoms | -11.24 score on a scale | Standard Deviation 11.67 |
| Group C- Moodivate + EHR | Mean Score of Depressive Symptoms | -10.69 score on a scale | Standard Deviation 12.87 |