Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders

NCT01882608 | Completed

• 1 other identifier: 107-2012
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Major Depressive Disorder; Bipolar Disorder; Dysthymia

Keywords

psychiatry; mental health; mood disorders; mood diaries; electronic diaries; cell phones; software; mental health telemetry; ecological momentary assessment

Outcome Measures

Primary Outcomes (2)

• Re-hospitalization rate

  Six months

• Quality-of-life

  Quality-of-Life in Bipolar Disorder (QoL.BD) self-report scale, completed at entry and bi-monthly

  Six months

Secondary Outcomes (4)

• Relapse rate

  Six months

• Participation rate

  At baseline

• Uptake rate

  3 months

• Reporting rate

  6 months

Study Arms (2)

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

Other: Mental Health Telemetry (MHT)

Interventions

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).

Mental Health Telemetry (MHT)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Dr. David Kreindler: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Dysthymic Disorder; Psychological Well-Being; Mood Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Bipolar and Related Disorders; Personal Satisfaction; Behavior

Study Officials

• David M Kreindler, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 20, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

CA (1)