Calling for Care: Cell Phones for Mood Telemetry in Teens

Bipolar Disorder Clinical Trial

Official title:

Calling for Care: Cell Phones for Mood Telemetry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083823
• Other study ID #: 364-2007
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: April 19, 2012
• Start date: March 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 20 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bipolar Disorder
• Borderline Personality Disorder
• Cyclothymia
• Cyclothymic Disorder
• Disease
• Personality Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Motorola Canada Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	usability	Assessment of participant drop-out and reporting rates	After nine months' enrollment	No
Secondary	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	Every three months x 9 months	No
Secondary	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	After nine months' enrollment	No

External Links

•   Calling for Care web page