Calling for Care: Cell Phones for Mood Telemetry in Teens
This study has been completed.
Sponsor:
Sunnybrook Health Sciences Centre
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
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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:
MedlinePlus related topics:
Bipolar Disorder
Child Mental Health
Mental Health
Personality Disorders
U.S. FDA Resources
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 May 23, 2013