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Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders (PATH-MOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01882608
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : April 18, 2016
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. David Kreindler, Sunnybrook Health Sciences Centre

Brief Summary:
Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are due to mood disorders. Mental health telemetry (MHT) lets patients in the community use cell phones to track the severity of their mood symptoms over time, and enables clinicians to view these symptom ratings in real-time. Evidence suggests that MHT is better for detecting exacerbations of illness earlier than standard clinical practice alone. In this study, we will assess if MHT can reduce re-hospitalization rates in previously-hospitalized patients with mood disorders.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Bipolar Disorder Dysthymia Other: Mental Health Telemetry (MHT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders
Study Start Date : October 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Treatment-as-usual
Treatment-as-usual, with no active intervention or follow-up. TAU patients will have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians
Experimental: Mental Health Telemetry (MHT)
Patients in the MHT group will be encouraged to provide daily symptom self-reports using MHT. MHT patients will also have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians
Other: Mental Health Telemetry (MHT)
Ecological momentary assessment (EMA) focuses on using data collected from subjects living their daily lives in their natural environments using minimally invasive techniques to improve the quality of the data collected. MHT is an evolution of EMA. MHT was developed at Sunnybrook in partnership with the University of Toronto; it uses cell phones to collect self-report data on symptoms of illness and then transmit it in real-time to a central database. Principal advantages of MHT over EMA include the ability to time- and date-stamp data, thus eliminating retrospective record completion, and the ability to observe and monitor data flow in real-time, without having to wait for participants to upload or deliver the data (e.g., at their next doctors' appointment).

Primary Outcome Measures :
  1. Re-hospitalization rate [ Time Frame: Six months ]
  2. Quality-of-life [ Time Frame: Six months ]
    Quality-of-Life in Bipolar Disorder (QoL.BD) self-report scale, completed at entry and bi-monthly

Secondary Outcome Measures :
  1. Relapse rate [ Time Frame: Six months ]
    Rate of recurrence of clinical episode of mood disorders

  2. Participation rate [ Time Frame: At baseline ]
    Proportion of eligible patients who agree to participate

  3. Uptake rate [ Time Frame: 3 months ]
    Percent of patients using MHT relative to number of eligible patients

  4. Reporting rate [ Time Frame: 6 months ]
    Mean number of MHT reports generated per day among MHT users

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed DSM-IV mood disorder
  • Long-term follow-up at Sunnybrook
  • At least two lifetime hospitalizations for mood disorders at the time of recruitment
  • Own a web-enabled cell phone,
  • Be willing to start or continue with mood journaling using either MHT or some other platform / medium
  • Be able to be successfully trained to use MHT,
  • Have provided informed consent to participate,
  • Have a clinician in the Department of Psychiatry at Sunnybrook who is providing the majority of their mental health care and is participating in this study,
  • In the case of participants under the age of 18 years, have the assent of at least one custodial parent and / or legal guardian

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01882608

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Dr. David Kreindler
Sunnybrook Health Sciences Centre
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Principal Investigator: David M Kreindler, MD Sunnybrook Health Sciences Centre
Additional Information:
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Responsible Party: Dr. David Kreindler, Staff Physician, Sunnybrook Health Sciences Centre Identifier: NCT01882608    
Other Study ID Numbers: 107-2012
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Keywords provided by Dr. David Kreindler, Sunnybrook Health Sciences Centre:
mental health
mood disorders
mood diaries
electronic diaries
cell phones
mental health telemetry
ecological momentary assessment
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Mood Disorders
Pathologic Processes
Mental Disorders
Bipolar and Related Disorders