Major Depressive Disorder Clinical Trial
— PATH-MODOfficial title:
Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders
Verified date | April 2015 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 140 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
Inclusion Criteria: - 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, - 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 Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dr. David Kreindler | Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Re-hospitalization rate | Six months | No | |
Primary | Quality-of-life | Quality-of-Life in Bipolar Disorder (QoL.BD) self-report scale, completed at entry and bi-monthly | Six months | No |
Secondary | Relapse rate | Rate of recurrence of clinical episode of mood disorders | Six months | No |
Secondary | Participation rate | Proportion of eligible patients who agree to participate | At baseline | No |
Secondary | Uptake rate | Percent of patients using MHT relative to number of eligible patients | 3 months | No |
Secondary | Reporting rate | Mean number of MHT reports generated per day among MHT users | 6 months | No |
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