Major Depressive DisorderPATH-MODNCT01882608
Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders
A study testing Mental Health Telemetry (MHT) in people with Major Depressive Disorder and Bipolar Disorder, run by Dr. David Kreindler at 1 site in Canada.
Trial summary
Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are due to mood disorders. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Dysthymia
- 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
- Oct 2013to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed DSM-IV mood disorder
- Long-term follow-up at Sunnybrook
- At least two lifetime hospitalizations for mood disorders at the time of recruitment
- Own a web-enabled cell phone,
- Be willing to start or continue with mood journaling using either MHT or some other platform / medium
- Be able to be successfully trained to use MHT,
Show all 9Show fewer
- Have provided informed consent to participate,
- Have a clinician in the Department of Psychiatry at Sunnybrook who is providing the majority of their mental health care and is participating in this study,
- In the case of participants under the age of 18 years, have the assent of at least one custodial parent and / or legal guardian
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are due to mood disorders. Mental health telemetry (MHT) lets patients in the community use cell phones to track the severity of their mood symptoms over time, and enables clinicians to view these symptom ratings in real-time. Evidence suggests that MHT is better for detecting exacerbations of illness earlier than standard clinical practice alone. In this study, we will assess if MHT can reduce re-hospitalization rates in previously-hospitalized patients with mood disorders.
Read the detailed description
The mood disorders (major depressive disorder, bipolar disorder, and dysthymia) are a significant public health issue: mood disorders affect approximately one in four people during their lives; in total, over 8 million Canadians are affected by mood disorders, costing the economy over $6 billion annually. Mood disorders are generally recurrent: approximately 50% of cases of major depressive disorder will relapse at least once; 15% will run a chronic course. With bipolar disorder, a chronic course of episodes of depression and/or mania intermixed with episodes of normal mood is typical. At Sunnybrook (SHSC), 75% of inpatient mental health admissions are due to mood disorders. Clinically, with mood disorders, earlier recognition of symptom changes in patients provides greater potential for early intervention and suppression of relapses, which in turn leads to reduced outpatient resource utilization, fewer Emergency Department visits, and fewer readmissions.
Ecological momentary assessment (EMA), a body of work developed in the late 90s and early 00's, focuses on using data collected from subjects living their daily lives in their natural environments using minimally invasive techniques to improve the quality of the data collected. Mental health telemetry (MHT) is an evolution of EMA. MHT was developed here at Sunnybrook in partnership with the Faculty of Medicine at the University of Toronto; it uses wirelessly networked handheld computers - typically, cell phones - to collect self-report data on symptoms of illness and then transmit it in real-time to a central database. Principal advantages of MHT over EMA include (i) the ability to time- and date-stamp data, thus eliminating retrospective record completion, and (ii) the ability to observe and monitor data flow in real-time, without having to wait for participants to upload or deliver the data (e.g., at their next doctors' appointment).
MHT has been used to collect rich sets of longitudinal self-report ratings from patients while they live their daily lives in the community; populations studied include adults with depression, premenstrual syndrome, and bipolar disorder (for as long as 18 months), as well as teens with mood swings (for as long as nine months). Adherence to daily (or more frequent) symptom reporting using MHT in these studies has been very good, with adherence rates of 75±5 % over the duration of the studies.
MHT has considerable potential to reduce rates of inpatient re-hospitalization for mood disorders. EMA methods have previously shown to be superior to standard patient follow-ups for detecting medication response in depression14 or days ill in bipolar disorder18. While numerous previous studies have looked at general patterns of recurrence and prognostic factors in the long-term course of major depressive disorder4;23;24;27 and bipolar disorder, none have looked at using EMA or MHT data to monitor for signs of imminent relapse in individual cases. The rich data stream provided by MHT will allow us to do this for the first time, similar to how ECG telemetry is routinely used for diagnostic and prognostic purposes. Doing so will enable clinicians to trigger early community- or outpatient-based interventions, thus reducing the likelihood of relapse and / or hospitalization.
One limitation of the MHT studies to-date has been the platform-specific nature of the MHT systems used: rather than using platform-independent software, the systems deployed to date have been custom-created for specific cell-phone platforms (e.g., the Kyocera pdQ 1900, the Palm Treo family of SmartPhones, or the Motorola QA30). As a result, until now, MHT has been limited use by participants in research studies who were provided with a research-funded cell phone.
Therefore, to explore the feasibility of using MHT to reduce re-hospitalization in patients with diagnosed mood disorders, we will:
- Upgrade our existing patient MHT software (for recording MHT) to a web-based platform, thus removing all hardware dependency from MHT and allowing anyone who has a web-capable cell phone to use MHT essentially without cost;
- Upgrade our existing clinician PATH software (for viewing patients' MHT), optimizing its user interface to make it easy for clinicians to rapidly and effectively visualize their patients' telemetry;
- Distribute clinician PATH software to interested clinicians within the SHSC Department of Psychiatry, to enable clinicians to receive daily, patient-generated, quantitative symptom severity ratings as well as medication adherence and side-effect reports from their patients. (Clinicians will use this information in collaboration with their patients to aid in monitoring patients' mental status over the course of this study.)
- Over the duration of the study, distribute patient MHT software to a random sample of patients with (i) a mood disorder being discharged from Sunnybrook's inpatient mental health ward (F2) or (ii) bipolar disorder being followed in the outpatient psychiatry clinics at Sunnybrook; then,
- Compare re-hospitalization rates and quality-of-life measures of MHT users over a 6 month period to a control group of similar patients not using MHT.
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Dysthymia
- Being tested
- Mental Health Telemetry (MHT)
- Keywords
- psychiatry, mental health, mood disorders, mood diaries, electronic diaries, cell phones, software, mental health telemetry, ecological momentary assessment
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Dysthymic Disorder, Psychological Well-Being, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Telemetry (MHT)Other
Ecological momentary assessment (EMA) focuses on using data collected from subjects living their daily lives in their natural environments using minimally invasive techniques to improve the quality of the data collected. MHT is an evolution of EMA. MHT was developed at Sunnybrook in partnership with the University of Toronto; it uses cell phones to collect self-report data on symptoms of illness and then transmit it in real-time to a central database. Principal advantages of MHT over EMA include the ability to time- and date-stamp data, thus eliminating retrospective record completion, and the ability to observe and monitor data flow in real-time, without having to wait for participants to upload or deliver the data (e.g., at their next doctors' appointment).
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual | No intervention | Treatment-as-usual, with no active intervention or follow-up. TAU patients will have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians |
| Mental Health Telemetry (MHT) | Experimental | Patients in the MHT group will be encouraged to provide daily symptom self-reports using MHT. MHT patients will also have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians Receives: Other: Mental Health Telemetry (MHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization rate
Measured: Six months
Quality-of-life
Quality-of-Life in Bipolar Disorder (QoL.BD) self-report scale, completed at entry and bi-monthly
Measured: Six months
Secondary outcomes (4)
Relapse rate
Rate of recurrence of clinical episode of mood disorders
Measured: Six months
Participation rate
Proportion of eligible patients who agree to participate
Measured: At baseline
Uptake rate
Percent of patients using MHT relative to number of eligible patients
Measured: 3 months
Reporting rate
Mean number of MHT reports generated per day among MHT users
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. David Kreindler
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor-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
- NCT01882608
- Sponsor's protocol ID
- 107-2012
- Acronym
- PATH-MOD
- Status last verified
- Apr 2016
- First submitted
- 18 Jun 2013
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders
- ClinicalTrials.gov ID
- NCT01882608
- Acronym / sponsor ID
- PATH-MOD / 107-2012
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Dysthymia
- Keywords
- psychiatry, mental health, mood disorders, mood diaries, electronic diaries, cell phones, software, mental health telemetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dr. David KreindlerUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Jun 2013 (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.
Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are due to mood disorders. Mental health telemetry (MHT) lets patients in the community use cell phones to track the severity of their mood symptoms over time, and enables clinicians to view these symptom ratings in real-time. Evidence suggests that MHT is better for detecting exacerbations of illness earlier than standard clinical practice alone. In this study, we will assess if MHT can reduce re-hospitalization rates in previously-hospitalized patients with mood disorders.
Detailed description
The mood disorders (major depressive disorder, bipolar disorder, and dysthymia) are a significant public health issue: mood disorders affect approximately one in four people during their lives; in total, over 8 million Canadians are affected by mood disorders, costing the economy over $6 billion annually. Mood disorders are generally recurrent: approximately 50% of cases of major depressive disorder will relapse at least once; 15% will run a chronic course. With bipolar disorder, a chronic course of episodes of depression and/or mania intermixed with episodes of normal mood is typical. At Sunnybrook (SHSC), 75% of inpatient mental health admissions are due to mood disorders. Clinically, with mood disorders, earlier recognition of symptom changes in patients provides greater potential for early intervention and suppression of relapses, which in turn leads to reduced outpatient resource utilization, fewer Emergency Department visits, and fewer readmissions.
Ecological momentary assessment (EMA), a body of work developed in the late 90s and early 00's, focuses on using data collected from subjects living their daily lives in their natural environments using minimally invasive techniques to improve the quality of the data collected. Mental health telemetry (MHT) is an evolution of EMA. MHT was developed here at Sunnybrook in partnership with the Faculty of Medicine at the University of Toronto; it uses wirelessly networked handheld computers - typically, cell phones - to collect self-report data on symptoms of illness and then transmit it in real-time to a central database. Principal advantages of MHT over EMA include (i) the ability to time- and date-stamp data, thus eliminating retrospective record completion, and (ii) the ability to observe and monitor data flow in real-time, without having to wait for participants to upload or deliver the data (e.g., at their next doctors' appointment).
MHT has been used to collect rich sets of longitudinal self-report ratings from patients while they live their daily lives in the community; populations studied include adults with depression, premenstrual syndrome, and bipolar disorder (for as long as 18 months), as well as teens with mood swings (for as long as nine months). Adherence to daily (or more frequent) symptom reporting using MHT in these studies has been very good, with adherence rates of 75±5 % over the duration of the studies.
MHT has considerable potential to reduce rates of inpatient re-hospitalization for mood disorders. EMA methods have previously shown to be superior to standard patient follow-ups for detecting medication response in depression14 or days ill in bipolar disorder18. While numerous previous studies have looked at general patterns of recurrence and prognostic factors in the long-term course of major depressive disorder4;23;24;27 and bipolar disorder, none have looked at using EMA or MHT data to monitor for signs of imminent relapse in individual cases. The rich data stream provided by MHT will allow us to do this for the first time, similar to how ECG telemetry is routinely used for diagnostic and prognostic purposes. Doing so will enable clinicians to trigger early community- or outpatient-based interventions, thus reducing the likelihood of relapse and / or hospitalization.
One limitation of the MHT studies to-date has been the platform-specific nature of the MHT systems used: rather than using platform-independent software, the systems deployed to date have been custom-created for specific cell-phone platforms (e.g., the Kyocera pdQ 1900, the Palm Treo family of SmartPhones, or the Motorola QA30). As a result, until now, MHT has been limited use by participants in research studies who were provided with a research-funded cell phone.
Therefore, to explore the feasibility of using MHT to reduce re-hospitalization in patients with diagnosed mood disorders, we will:
- Upgrade our existing patient MHT software (for recording MHT) to a web-based platform, thus removing all hardware dependency from MHT and allowing anyone who has a web-capable cell phone to use MHT essentially without cost;
- Upgrade our existing clinician PATH software (for viewing patients' MHT), optimizing its user interface to make it easy for clinicians to rapidly and effectively visualize their patients' telemetry;
- Distribute clinician PATH software to interested clinicians within the SHSC Department of Psychiatry, to enable clinicians to receive daily, patient-generated, quantitative symptom severity ratings as well as medication adherence and side-effect reports from their patients. (Clinicians will use this information in collaboration with their patients to aid in monitoring patients' mental status over the course of this study.)
- Over the duration of the study, distribute patient MHT software to a random sample of patients with (i) a mood disorder being discharged from Sunnybrook's inpatient mental health ward (F2) or (ii) bipolar disorder being followed in the outpatient psychiatry clinics at Sunnybrook; then,
- Compare re-hospitalization rates and quality-of-life measures of MHT users over a 6 month period to a control group of similar patients not using MHT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual | No intervention | –Treatment-as-usual, with no active intervention or follow-up. TAU patients will have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians |
| Mental Health Telemetry (MHT) | Experimental | Other: Mental Health Telemetry (MHT)Patients in the MHT group will be encouraged to provide daily symptom self-reports using MHT. MHT patients will also have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed DSM-IV mood disorder
- Long-term follow-up at Sunnybrook
- At least two lifetime hospitalizations for mood disorders at the time of recruitment
- Own a web-enabled cell phone,
- Be willing to start or continue with mood journaling using either MHT or some other platform / medium
Key exclusion criteria (1 listed)
- -
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)Ecological momentary assessment (EMA) focuses on using data collected from subjects living their daily lives in their natural environments using minimally invasive techniques to improve the quality of the data collected. MHT is an evolution of EMA. MHT was developed at Sunnybrook in partnership with the University of Toronto; it uses cell phones to collect self-report data on symptoms of illness and then transmit it in real-time to a central database. Principal advantages of MHT over EMA include the ability to time- and date-stamp data, thus eliminating retrospective record completion, and the ability to observe and monitor data flow in real-time, without having to wait for participants to upload or deliver the data (e.g., at their next doctors' appointment). | Other | Mental Health Telemetry (MHT) |
Primary outcome
Re-hospitalization rate
Time frame: Six months
Quality-of-life
Time frame: Six months
Quality-of-Life in Bipolar Disorder (QoL.BD) self-report scale, completed at entry and bi-monthly
4 secondary outcomes
Relapse rate
Time frame: Six months
Participation rate
Time frame: At baseline
Uptake rate
Time frame: 3 months
Reporting rate
Time frame: 6 months
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 18 Apr 2016.
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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?
A study testing Mental Health Telemetry (MHT) in people with Major Depressive Disorder and Bipolar Disorder, run by Dr. David Kreindler 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 9 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: finished, as of the sponsor's last update on 18 Apr 2016. 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?
Re-hospitalization rate (time frame: Six months). The study lists 2 primary outcomes in all. 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 18 Apr 2016.