Calling for Care: Cell Phones for Mood Telemetry in Teens

Study Overview
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Brief Summary
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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.

Official Title
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Calling for Care: Cell Phones for Mood Telemetry

Conditions
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Bipolar Disorder, Cyclothymia, Borderline Personality Disorder

Intervention / Treatment
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* Other: Mental health telemetry (MHT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-reported mood swings<br>Participants who self-identify as experiencing severe mood swings that interfere with life. | Other: Mental health telemetry (MHT)<br>* 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.<br>* Other names: Mood telemetry;|
| Active Comparator: Healthy<br>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)<br>* 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.<br>* Other names: Mood telemetry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usability | Assessment of participant drop-out and reporting rates | After nine months' enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental health telemetry, Mood telemetry, Mood, Bipolar disorder, Affective instability, Cyclothymia, Electronic diaries, Mood diaries, Mood swings