Mental Health Telemetry for Self-Management in Major Depression (MHTV)

This study is not yet open for participant recruitment.
Verified November 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01999010
First received: August 1, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Device: MHT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mental Health Telemetry for Self-Management in Major Depression

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Change in self-management ratings [ Time Frame: two months and four months ] [ Designated as safety issue: No ]
    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:
  • Change in Quality-of-life (QoL) ratings [ Time Frame: two months and four months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Retention Rates (Exploratory) [ Time Frame: Four months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 113
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as usual ("A" Stage)
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.
Experimental: MHT ("B" Stage)
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
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.
Experimental: Choice ("A' " Stage)
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
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

We will recruit (n=113) age- (within 5 years) and sex-matched patients with a Diagnostic and Statistical Manual, 4th Ed. (DSM-IV) diagnosis of MDD, confirmed using the MDD section of the MINI. We will recruit in blocks of 20 to ensure age- and sex matching before recruiting the next block. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999010

Contacts
Contact: Tasmia Hai, B.Sc. 416-528-0396 tasmia.hai@sunnybrook.ca
Contact: David M Kreindler, B.Sc., M.D. 416-480-5225 david.kreindler@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Sub-Investigator: Anthony Levitt, MD         
Principal Investigator: David M Kreindler, B.Sc., MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: David M Kreindler, MD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01999010     History of Changes
Other Study ID Numbers: 186-2013
Study First Received: August 1, 2013
Last Updated: November 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
mental health
mental health telemetry
psychiatry
major depressive disorder
self-management
data visualization
mood diaries
electronic diaries
cell phones
software
ecological momentary assessment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014