Major Depressive Disorder
Conditions
Brief summary
The current randomized controlled trial is a pilot study that will assess the effectiveness and feasibility of a mobile phone application intervention. The objective is to determine whether the use of a mobile health application for patient self-management of depression improves patient-provider engagement for patients diagnosed with major depressive disorder.
Detailed description
This pilot study will be a randomized, real-world effectiveness study. Patients diagnosed with major depressive disorder starting a new prescription for an antidepressant monotherapy will be eligible for participation. The study will enroll 40 patients (20 in an observational arm of usual care and 20 with access to a mobile health application). No intervention will occur in the usual care arm. The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression. Patient reported outcomes and clinical data will be collected at baseline and at study primary endpoint (18 weeks) to assess changes over time and between groups for: patient-provider engagement, disease severity, quality of life, employment productivity, cognitive function, resource utilization, and medication adherence. Additionally, resource utilization will be assessed at the one year time point. A Student's t test, if allowed for by the data distribution, will be used to assess between group differences in patient reported outcome scales assessing patient-provider engagement.
Interventions
BEHAVIORALMobile App
The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression.
Sponsors
Takeda
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 * Ability to consent and participate in study (technical requirements for app: iPhone version 5 or later, active data plan or regular WiFi access) * Diagnosis with major depressive disorder * PHQ-9 score greater than 5 at baseline * Recent (0-14 days) start on monotherapy depression medication (either new prescription or a change from a previous medication) * Outpatient care provided by participating Advocate Medical Group clinics
Exclusion criteria
* Diagnosis with major psychiatric disorder (e.g. bipolar disorder, manic depressive disorder) * Contraindications to use of depression medications * Patients with treatment resistant depression \[defined as patients who have not responded to two or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in the current depressive episode\] * Considered at imminent risk for hospitalization due to severe depression in the opinion of the treating physician * History of hospitalization due to major depressive disorder in prior 3 months * Significant risk of suicide according to the treating physician's clinical judgment or previous suicide attempt in prior 6 months * History of response only to combination or augmentation therapy in current depressive episode * Receipt of any investigational compound in prior 30 days (or five half-lives, whichever is longer) * Current participation in another clinical study * Lack of functional English literacy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-provider engagement | 18 weeks | This will be assessed by the Patient-Provider Engagement Scale (PPES-7), an instrument developed for this study to measure patient knowledge, communication, and interaction with their provider specific to depression management. |
| Patient activation | 18 weeks | This will be assessed by the Patient Activation Measure, a validated scale that measures patient knowledge, skills and confidence in disease self-management in the primary care setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive dysfunction | 18 weeks | This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale. |
| Medication changes | 18 weeks | This outcome will be assessed by clinical data on the frequency and types of medication switches. |
| Health care utilization | 18 weeks | This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey. |
| WHO-5 survey | 18 weeks | This patient reported outcome is assessed by the quality of life WHO-5 survey. |
| Depression symptoms | 18 weeks | This patient reported outcome is assessed by the clinical depression severity. PHQ-9 scale, which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Long-term follow health care utilization | 1 year | This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey. |
Countries
United States
Outcome results
None listed