Calling for Care: Cell Phones for Mood Telemetry in Teens

This study has been completed.
Sponsor:
Collaborator:
Motorola Canada Limited
Information provided by (Responsible Party):
Dr. David Kreindler, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01083823
First received: March 8, 2010
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

We will modify our existing VMQ/VADIS mood telemetry software to run on a Motorola platform, and enhance it to collect information on both mood symptoms (currently covered by the VMQ/VADIS) as well as daily life stressors (currently outside the VMQ/VADIS' scope). By doing so, we will be able us to examine the role of daily stressors in the lives of teens with and without mood swings, to identify how changes in mood triggered by stressful events are similar to or different from mood changes linked to the bipolar disorder, borderline personality disorder, or other forms of affective instability.


Condition Intervention
Bipolar Disorder
Cyclothymia
Borderline Personality Disorder
Other: Mental health telemetry (MHT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Calling for Care: Cell Phones for Mood Telemetry

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • usability [ Time Frame: After nine months' enrollment ] [ Designated as safety issue: No ]
    Assessment of participant drop-out and reporting rates


Secondary Outcome Measures:
  • Validity [ Time Frame: Every three months x 9 months ] [ Designated as safety issue: No ]
    Validate that the data reported by telemetry is valid, by comparing cell phone questionnaire responses with results of standardized clinical ratings collected every-three-month via face-to-face meetings

  • Qualitative feedback [ Time Frame: After nine months' enrollment ] [ Designated as safety issue: No ]
    Collect human factors engineering feedback from our participants for subsequent development work, by questioning participants at the exit interview about their experience with the cell phone and software


Enrollment: 33
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Self-reported mood swings
Participants who self-identify as experiencing severe mood swings that interfere with life.
Other: Mental health telemetry (MHT)
Use a cell phone equipped with MHT software to complete a self-report mood symptom questionnaire daily at a fixed time of day, as well as additional discretionary questionnaires following any significantly stressful events.
Other Name: Mood telemetry
Active Comparator: Healthy
Participants who self-identify as not experiencing mood swings in the past or at present and who deny past / present problems with substance use.
Other: Mental health telemetry (MHT)
Use a cell phone equipped with MHT software to complete a self-report mood symptom questionnaire daily at a fixed time of day, as well as additional discretionary questionnaires following any significantly stressful events.
Other Name: Mood telemetry

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 14-20yrs,
  • Either (i) self-reported healthy with no past / present history of substance use problems OR (ii) self-reported severe mood swings interfering with daily life.
  • Fluent in English.

Exclusion Criteria:

  • Inability to be trained successfully on the MHT software or to complete questionnaires without assistance.
  • Unwillingness to sign / maintain a contract with a cell phone service provider.
  • Lack of parental assent / willingness to act as guarantor for cell phone provider contract
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083823

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Motorola Canada Limited
Investigators
Principal Investigator: David M Kreindler, MD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. David Kreindler, Active Staff, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01083823     History of Changes
Other Study ID Numbers: 364-2007
Study First Received: March 8, 2010
Last Updated: April 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Mental health telemetry
Mood telemetry
Mood
Bipolar disorder
Affective instability
Cyclothymia
Electronic diaries
Mood diaries
Mood swings

Additional relevant MeSH terms:
Bipolar Disorder
Borderline Personality Disorder
Cyclothymic Disorder
Personality Disorders
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014