Major Depressive Disorder
Conditions
Keywords
psychiatry, mental health, major depressive disorder, self-management, data visualization, mood diaries, electronic diaries, cell phones, software, mental health telemetry, ecological momentary assessment
Brief summary
Mood journaling is a cornerstone of self-management in major depressive disorder (MDD). Research over the last decade has shown that electronic mood journals are superior to paper ones. One potential advantage of mental health telemetry (MHT), which use cell phones to collect mood journal data, is that electronic journal data can easily be converted into graphical records, allowing people living with MDD to readily spot trends, correlations, or patterns in ways that would be quite challenging using paper diaries. This information should make it easier to recognize and evaluate changes in mental health status -- the first two steps in the process of self-management. The investigators will develop and deploy a visualization module for patients with which to explore their own MHT data sets on the same cell phones which they record their journals, and test the investigators hypotheses that their enhanced MHT system will (i) improve patients' ability to self-manage MDD and (ii) enhance their quality-of-life. The study is a non-randomized, un-blinded, A-B-A' (modified single-subject withdrawal design, with user choice of treatment or withdrawal in the A' stage) study, to explore the utility of MHT as a tool for enhancing self-management and QoL for persons living with MDD. The aims of this study are to explore the impact of MHT on subjects' self-management and QoL, and to gauge participants' perceptions of MHT's utility.
Interventions
DEVICEMHT
MHT and visualizer contains mood information about the patient themselves, which allows for self management of the mood disorder. Self-management interventions promote early recognition of mood episodes, medication adherence and self-management skills which have shown to improve outcomes in depression. MHT encourages patients to take an active role by engaging in mood journaling, while making this information available in explorable form to the patient and his / her team of clinicians.
Sponsors
Canadian Institutes of Health Research (CIHR)
Sunnybrook Health Sciences Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We will recruit (n=113) patients with a Diagnostic and Statistical Manual, 4th Ed. (DSM-IV) diagnosis of MDD, confirmed using the MDD section of the M.I.N.I. International Neuropsychiatric Interview (MINI) version 5.0. All recruits will own or use a web-enabled cell phone.
Exclusion criteria
* self-disclosed illiteracy; * blindness; * inability to be successfully trained in the use of MHT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-management ratings | two months and four months | Self-management ratings using the three sub-scale scores (maintenance, management, and confidence) of the Sunnybrook Self-Management Scale - Depression (3S-D) instrument at the end of the Treatment-as-Usual phase (two months) as compared to the end of the active treatment phase (four months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality-of-life (QoL) ratings | two months and four months | Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) scores at the end of the treatment-as-usual (two months) and active treatment (four months) phases. We will control for severity of mood symptoms (using mental health telemetry (MHT) composite depression scores) as a covariate of the magnitude of change in QoL outcomes because we expect that some, but not all, of the variance in QoL outcomes will be accounted for in particular by the severity of depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Retention Rates (Exploratory) | Four months | We will report the proportion and 95% confidence interval (CI) of users who opt to continue using MHT in the A' (user choice) phase |
| Utilization Rates (Exploratory) | Six months | We will report the mean number and 95% CI of times per patient (in the B and A' phases) that MHT data was (i) reported and (ii) visualized. |
Countries
Canada
Outcome results
None listed