Calling for Care: Cell Phones for Mood Telemetry in Teens
April 19, 2012 updated by: Dr. David Kreindler, Sunnybrook Health Sciences Centre
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Self-reported mood swings
Participants who self-identify as experiencing severe mood swings that interfere with life.
|
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 Names:
|
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
usability
Time Frame: After nine months' enrollment
|
Assessment of participant drop-out and reporting rates
|
After nine months' enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Every three months x 9 months
|
|
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
|
After nine months' enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David M Kreindler, MD, Sunnybrook Health Sciences Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
March 8, 2010
First Submitted That Met QC Criteria
March 8, 2010
First Posted (Estimate)
March 10, 2010
Study Record Updates
Last Update Posted (Estimate)
April 20, 2012
Last Update Submitted That Met QC Criteria
April 19, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 364-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.