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Calling for Care: Cell Phones for Mood Telemetry in Teens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083823
First Posted: March 10, 2010
Last Update Posted: April 20, 2012
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.
Collaborator:
Motorola Canada Limited
Information provided by (Responsible Party):
Dr. David Kreindler, Sunnybrook Health Sciences Centre
March 8, 2010
March 10, 2010
April 20, 2012
March 2010
April 2012   (Final data collection date for primary outcome measure)
usability [ Time Frame: After nine months' enrollment ]
Assessment of participant drop-out and reporting rates
Same as current
Complete list of historical versions of study NCT01083823 on ClinicalTrials.gov Archive Site
  • Validity [ Time Frame: Every three months x 9 months ]
    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 ]
    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
Same as current
Not Provided
Not Provided
 
Calling for Care: Cell Phones for Mood Telemetry in Teens
Calling for Care: Cell Phones for Mood Telemetry
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Bipolar Disorder
  • Cyclothymia
  • Borderline Personality Disorder
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: Self-reported mood swings
    Participants who self-identify as experiencing severe mood swings that interfere with life.
    Intervention: Other: Mental health telemetry (MHT)
  • 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.
    Intervention: Other: Mental health telemetry (MHT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years to 20 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01083823
364-2007
No
Not Provided
Not Provided
Dr. David Kreindler, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Motorola Canada Limited
Principal Investigator: David M Kreindler, MD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP