Mental Health Telemetry for Self-Management in Major Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: MHT

• Registration Number: NCT01999010
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Study Start: 2014-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-11
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

• self-disclosed illiteracy;
• blindness;
• inability to be successfully trained in the use of MHT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Choice ("A' " Stage)	MHT	Patients exiting the MHT arm will be given the choice to continue with MHT for a further two months or whether to resume TAU (i.e., no further use of MHT) for the remaining two months.
MHT ("B" Stage)	MHT	Patients will be given software for Mental Health Telemetry (MHT), which allows them to record symptom intensity, hospital / ER visits, life events, etc., and to visualize their MHT data. Patients will be encouraged to make MHT entries once daily at a pre-determined time while in this arm, and will be prompted via text message by the MHT software to do so.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada