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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MHT
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring psychiatry, mental health, major depressive disorder, self-management, data visualization, mood diaries, electronic diaries, cell phones, software, mental health telemetry, ecological momentary assessment

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Treatment as usual ("A" Stage)

MHT ("B" Stage)

Choice ("A' " Stage)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2013
Last Updated
January 4, 2017
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01999010
Brief Title
Mental Health Telemetry for Self-Management in Major Depression
Acronym
MHTV
Official Title
Mental Health Telemetry for Self-Management in Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual ("A" Stage)
Arm Type
No Intervention
Arm Description
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.
Arm Title
MHT ("B" Stage)
Arm Type
Experimental
Arm Description
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.
Arm Title
Choice ("A' " Stage)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MHT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in self-management ratings
Description
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)
Time Frame
two months and four months
Secondary Outcome Measure Information:
Title
Change in Quality-of-life (QoL) ratings
Description
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.
Time Frame
two months and four months
Other Pre-specified Outcome Measures:
Title
Retention Rates (Exploratory)
Description
We will report the proportion and 95% confidence interval (CI) of users who opt to continue using MHT in the A' (user choice) phase
Time Frame
Four months
Title
Utilization Rates (Exploratory)
Description
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Kreindler, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://sunnybrook.ca/research/content/?page=sri-groups-cmcmh-home
Description
Centre for Mobile Computing in Mental Health

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Mental Health Telemetry for Self-Management in Major Depression

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