Bipolar DisorderNCT01083823
Calling for Care: Cell Phones for Mood Telemetry in Teens
A study testing Mental health telemetry (MHT) in people with Bipolar Disorder and Cyclothymia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Cyclothymia, Borderline Personality Disorder
- What is being tested?
- Mental health telemetry (MHT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calling for Care: Cell Phones for Mood Telemetry
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.
- Being tested
- Mental health telemetry (MHT)
- Keywords
- Mental health telemetry, Mood telemetry, Mood, Bipolar disorder, Affective instability, Cyclothymia, Electronic diaries, Mood diaries, Mood swings
- Medical subject headings
- Bipolar Disorder, Cyclothymic Disorder, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental health telemetry (MHT)Other
Also called Mood telemetry
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-reported mood swings | Active comparator | Participants who self-identify as experiencing severe mood swings that interfere with life. Receives: 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. Receives: Other: Mental health telemetry (MHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
usability
Assessment of participant drop-out and reporting rates
Measured: After nine months' enrollment
Secondary outcomes (2)
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
Measured: 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
Measured: After nine months' enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Motorola Canada Limited
- Responsible party
- Principal investigator, Dr. David Kreindler, Sunnybrook Health Sciences Centre
- Investigators
- David M Kreindler, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083823
- Sponsor's protocol ID
- 364-2007
- Status last verified
- Apr 2012
- First submitted
- 8 Mar 2010
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calling for Care: Cell Phones for Mood Telemetry
- ClinicalTrials.gov ID
- NCT01083823
- Acronym / sponsor ID
- 364-2007
- Keywords
- Mental health telemetry, Mood telemetry, Mood, Bipolar disorder, Affective instability, Cyclothymia, Electronic diaries, Mood diaries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Motorola Canada Limited
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-reported mood swings | Active comparator | Other: Mental health telemetry (MHT)Participants who self-identify as experiencing severe mood swings that interfere with life. |
| Healthy | Active comparator | Other: Mental health telemetry (MHT)Participants who self-identify as not experiencing mood swings in the past or at present and who deny past / present problems with substance use. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental health telemetry (MHT)Also: Mood telemetryUse 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 | Healthy, Self-reported mood swings |
Primary outcome
usability
Time frame: After nine months' enrollment
Assessment of participant drop-out and reporting rates
2 secondary outcomes
Validity
Time frame: Every three months x 9 months
Qualitative feedback
Time frame: After nine months' enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Kreindler, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental health telemetry (MHT) in people with Bipolar Disorder and Cyclothymia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usability (time frame: After nine months' enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.