Calling for Care: Cell Phones for Mood Telemetry in Teens

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2010

Last Updated Date

April 19, 2012

Start Date ^ICMJE

March 2010

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

usability [ Time Frame: After nine months' enrollment ] [ Designated as safety issue: No ]

Assessment of participant drop-out and reporting rates

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01083823 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Calling for Care: Cell Phones for Mood Telemetry in Teens

Official Title ^ICMJE

Calling for Care: Cell Phones for Mood Telemetry

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Bipolar Disorder
Cyclothymia
Borderline Personality Disorder

Intervention ^ICMJE

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

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Years to 20 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01083823

Other Study ID Numbers ^ICMJE

364-2007

Has Data Monitoring Committee

Responsible Party

Dr. David Kreindler, Sunnybrook Health Sciences Centre

Study Sponsor ^ICMJE

Sunnybrook Health Sciences Centre

Collaborators ^ICMJE

Motorola Canada Limited

Investigators ^ICMJE

Principal Investigator:

David M Kreindler, MD

Sunnybrook Health Sciences Centre

Information Provided By

Sunnybrook Health Sciences Centre

Verification Date

April 2012

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

To Top