Bipolar DisorderNCT04664374
Characterizing MyMood Patterns of Use
An observational study of Bipolar Disorder and Mood Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
MyMood is an electronic mood-charting tool available to the general population of Sunnybrook Health Sciences Centre (SHSC). This project aims to characterize duration and frequency of use of MyMood by users characteristics and determine if there is any significant variability in duration and frequency of use… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder, Mood Disorders, Depression
- What is being tested?
- MyMood
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2020to 6 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal
Who may be able to join
- Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
MyMood is an electronic mood-charting tool available to the general population of Sunnybrook Health Sciences Centre (SHSC). This project aims to characterize duration and frequency of use of MyMood by users characteristics and determine if there is any significant variability in duration and frequency of use attributable to users' age, sex, self-reported diagnosis of a mood disorder, and/or prior treatment.
Read the detailed description
Mental Health Telemetry (MHT) is a software platform developed at Sunnybrook for collecting real-time self-report symptom-rating questionnaire data using patients' cell phones or other portable, Internet-enabled devices. MHT has previously been used in several funded clinical research studies. The mood-disorders-specific version of MHT, which we have named MyMood, collects information on a variety of items including symptom severity, medication adherence, ER visits / hospital admissions, sleep, relationships, and life events. In our previous project, we made MyMood available to the general population of SHSC by integrating it into Sunnybrook's MyChart personal health record system and collected feedback from users, using the feedback to refine MyMood. In the current project, we aim to characterize long-term patterns of MyMood usage, examining how duration and frequency of use are affected by demographic and clinical characteristics of users (age, sex, present / reported diagnosis of a mood disorder, and/or prior treatment).
Please note that the _only_ route for entry into this study is self-referral: interested individuals who have signed themselves up for MyChart can choose to begin using MyMood on their own. There is no reason to contact the study team regarding recruitment.
- Conditions
- Bipolar Disorder, Mood Disorders, Depression, Dysthymia
- Being tested
- MyMood
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Depression, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMoodOther
Users will use the MyMood tool. Each MyMood session consists of a brief survey, followed by a few psycho-educational 'tips'(targeted psycho-educational interventions received from time to time based on symptom severity reports as determined by the software algorithm).
| Study group | Role | What they receive |
|---|---|---|
| Mood Disorder | Based on screening questions administered on-line as part of the enrollment process, participants will be divided into two groups: (i) those who screen positive for a history of mood disorders and (ii) all other participants. All outcome measures apply only to the mood disorder group. Receives: Other: MyMood | |
| Other | see above Receives: Other: MyMood |
What is being measured
The primary outcome is the main question the study is designed to answer.
MyMood Use
Number of MyMood reports generated per user per month
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start6 Jan 2020
- Primary completion6 Jan 2025 (estimated)
- Study completion6 Jan 2025 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- 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
- NCT04664374
- Sponsor's protocol ID
- 396-2019
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2020
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing MyMood Patterns of Use
- ClinicalTrials.gov ID
- NCT04664374
- Acronym / sponsor ID
- 396-2019
- Conditions
- Bipolar Disorder, Mood Disorders, Depression, Dysthymia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 6 Jan 2025 (estimated)
- Study completion
- 6 Jan 2025 (estimated)
- First posted
- 11 Dec 2020 (actual)
- 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.
MyMood is an electronic mood-charting tool available to the general population of Sunnybrook Health Sciences Centre (SHSC). This project aims to characterize duration and frequency of use of MyMood by users characteristics and determine if there is any significant variability in duration and frequency of use attributable to users' age, sex, self-reported diagnosis of a mood disorder, and/or prior treatment.
Detailed description
Mental Health Telemetry (MHT) is a software platform developed at Sunnybrook for collecting real-time self-report symptom-rating questionnaire data using patients' cell phones or other portable, Internet-enabled devices. MHT has previously been used in several funded clinical research studies. The mood-disorders-specific version of MHT, which we have named MyMood, collects information on a variety of items including symptom severity, medication adherence, ER visits / hospital admissions, sleep, relationships, and life events. In our previous project, we made MyMood available to the general population of SHSC by integrating it into Sunnybrook's MyChart personal health record system and collected feedback from users, using the feedback to refine MyMood. In the current project, we aim to characterize long-term patterns of MyMood usage, examining how duration and frequency of use are affected by demographic and clinical characteristics of users (age, sex, present / reported diagnosis of a mood disorder, and/or prior treatment).
Please note that the _only_ route for entry into this study is self-referral: interested individuals who have signed themselves up for MyChart can choose to begin using MyMood on their own. There is no reason to contact the study team regarding recruitment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mood Disorder | – | Other: MyMoodBased on screening questions administered on-line as part of the enrollment process, participants will be divided into two groups: (i) those who screen positive for a history of mood disorders and (ii) all other participants. All outcome measures apply only to the mood disorder group. |
| Other | – | Other: MyMoodsee above |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal
Key inclusion criteria (1 listed)
- Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| MyMoodUsers will use the MyMood tool. Each MyMood session consists of a brief survey, followed by a few psycho-educational 'tips'(targeted psycho-educational interventions received from time to time based on symptom severity reports as determined by the software algorithm). | Other | Mood Disorder, Other |
Primary outcome
MyMood Use
Time frame: 3 years
Number of MyMood reports generated per user per month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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?
An observational study of Bipolar Disorder and Mood Disorders, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
MyMood Use (time frame: 3 years). 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 10 Dec 2024.