NCT01083823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

2.1 years

First QC Date

March 8, 2010

Last Update Submit

April 19, 2012

Conditions

Keywords

Mental health telemetryMood telemetryMoodBipolar disorderAffective instabilityCyclothymiaElectronic diariesMood diariesMood swings

Outcome Measures

Primary Outcomes (1)

  • usability

    Assessment of participant drop-out and reporting rates

    After nine months' enrollment

Secondary Outcomes (2)

  • Validity

    Every three months x 9 months

  • Qualitative feedback

    After nine months' enrollment

Study Arms (2)

Self-reported mood swings

ACTIVE COMPARATOR

Participants who self-identify as experiencing severe mood swings that interfere with life.

Other: Mental health telemetry (MHT)

Healthy

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: Mood telemetry
HealthySelf-reported mood swings

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Bipolar DisorderCyclothymic DisorderBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersPersonality Disorders

Study Officials

  • David M Kreindler, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Active Staff

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 10, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations