Mental Health Telemetry for Self-Management in Major Depression

NCT01999010 | Completed

• 1 other identifier: 186-2013
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

psychiatry; mental health; major depressive disorder; self-management; data visualization; mood diaries; electronic diaries; cell phones; software; mental health telemetry; ecological momentary assessment

Outcome Measures

Primary Outcomes (1)

• Change in self-management ratings

  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)

  two months and four months

Secondary Outcomes (1)

• Change in Quality-of-life (QoL) ratings

  two months and four months

Other Outcomes (2)

• Retention Rates (Exploratory)

  Four months

• Utilization Rates (Exploratory)

  Six months

Study Arms (3)

Treatment as usual ("A" Stage)

NO INTERVENTION

The treatment as usual (TAU) group will continue to receive their usual treatment from their current treatment team - i.e. MHT will not be introduced during this phase.

MHT ("B" Stage)

EXPERIMENTAL

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.

Device: MHT

Choice ("A' " Stage)

EXPERIMENTAL

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.

Device: MHT

Interventions

MHT DEVICE

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.

Choice ("A' " Stage); MHT ("B" Stage)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Psychological Well-Being

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• David M Kreindler, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2016-11

Locations

CA (1)