Back to resultsCalling for Care: Cell Phones for Mood Telemetry in Teens
Primary Purpose
Bipolar Disorder, Cyclothymia, Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mental health telemetry (MHT)
Sponsored by
About this trial
This is an interventional basic science trial for Bipolar Disorder focused on measuring Mental health telemetry, Mood telemetry, Mood, Bipolar disorder, Affective instability, Cyclothymia, Electronic diaries, Mood diaries, Mood swings
Eligibility 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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Self-reported mood swings
Healthy
Arm Description
Participants who self-identify as experiencing severe mood swings that interfere with life.
Participants who self-identify as not experiencing mood swings in the past or at present and who deny past / present problems with substance use.
Outcomes
Primary Outcome Measures
usability
Assessment of participant drop-out and reporting rates
Secondary Outcome Measures
Validity
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
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
Full Information
NCT ID
NCT01083823
First Posted
March 8, 2010
Last Updated
April 19, 2012
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Motorola Canada Limited
1. Study Identification
Unique Protocol Identification Number
NCT01083823
Brief Title
Calling for Care: Cell Phones for Mood Telemetry in Teens
Official Title
Calling for Care: Cell Phones for Mood Telemetry
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Motorola Canada Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Cyclothymia, Borderline Personality Disorder
Keywords
Mental health telemetry, Mood telemetry, Mood, Bipolar disorder, Affective instability, Cyclothymia, Electronic diaries, Mood diaries, Mood swings
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-reported mood swings
Arm Type
Active Comparator
Arm Description
Participants who self-identify as experiencing severe mood swings that interfere with life.
Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Mental health telemetry (MHT)
Other Intervention Name(s)
Mood telemetry
Intervention Description
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.
Primary Outcome Measure Information:
Title
usability
Description
Assessment of participant drop-out and reporting rates
Time Frame
After nine months' enrollment
Secondary Outcome Measure Information:
Title
Validity
Description
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
Time Frame
Every three months x 9 months
Title
Qualitative feedback
Description
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
Time Frame
After nine months' enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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/?page=sri_groups_cmcmh_proj_4
Description
Calling for Care web page
Learn more about this trial
Calling for Care: Cell Phones for Mood Telemetry in Teens
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