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A Mobile Behavioral Monitoring Intervention for Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LiveWell System
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Behavior Therapy, Technology Assisted, Mobile Phone, Smartphone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV diagnosis of Bipolar Disorder Type I.
  • Minimum of 2 acute episodes in last 2 years.
  • Receiving psychiatric care from a mental health provider willing to receive notifications and information regarding subject symptom status via the LiveWell system.

Exclusion Criteria:

  • Not involved in current psychiatric care.
  • Current substance use disorders or other psychiatric diagnosis or symptoms (e.g. dissociate disorder, psychotic symptoms) for which participation in this study is either inappropriate or dangerous.
  • Pregnancy or plans to become pregnant.
  • Visual impairments limiting mobile phone use.
  • An inability to speak and read English.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LiveWell System

Treatment As Usual

Arm Description

For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will receive the psychosocial intervention via a smartphone and context-dependent feedback based on self-report and behavioral data. Providers whose patients are randomized to this arm will also be asked to enroll in order to receive information and notifications about patient status for the duration of the study.

For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will be asked to provide limited self-report data via the phone.

Outcomes

Primary Outcome Measures

Percent Time Symptomatic
Percent time symptomatic will be assessed using ratings that measure the presence and severity of manic and depressive symptoms.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2015
Last Updated
April 18, 2017
Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02405117
Brief Title
A Mobile Behavioral Monitoring Intervention for Bipolar Disorder
Official Title
A Mobile Behavioral Monitoring Intervention for Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 10, 2014 (Actual)
Primary Completion Date
April 10, 2017 (Actual)
Study Completion Date
April 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will develop and pilot a smartphone intervention, LiveWell, to enhance patient self-management of bipolar disorder and facilitate more efficient, timely care delivery by mental health providers. The intervention uses a mobile application to collect daily self-report and continuous behavioral data and adapts intervention content to create a highly tailored and user-responsive treatment system. Patient data collected by the phone will also be provided to clinicians to allow for better evaluation and targeting of treatment. The goal is to reduce symptoms and prevent relapse in patients with bipolar disorder.
Detailed Description
Bipolar disorder is a severe and chronic mental illness that significantly increases mortality and greatly impairs functioning. Despite the use of pharmacological treatments, multiple acute episodes, long episode duration, and significant inter-episode sub-syndromal symptoms are common in patients with bipolar disorder. As a result, patients with bipolar disorder are symptomatically ill about half the time. There is clear evidence that the addition of psychotherapeutic interventions to medication management improves treatment outcomes, yet only about half of bipolar patients receive combined treatment. Current therapies also have limitations in terms of: 1) reliance on subjective patient self report and 2) difficulties in identifying warning signs of impending episodes. Furthermore, direct measurement of observable daily patterns of behavior is not routinely available, even though alterations in sleep and activity are core symptoms of bipolar disorder. Improving access to and long-term engagement in psychosocial interventions is needed to substantially improve treatment. The investigators are developing a smartphone intervention that aims to make proven psychosocial interventions for bipolar disorder more readily and routinely accessible to patients as part of their day-to-day lives. The intervention, called LiveWell, will capture and feedback data about sleep and activity to assist patients in regularizing daily rhythms as well as help them monitor, recognize, and manage early warning signs of impending mood episodes. Behavioral and self-report data collected by the phone will also be used to provide clinicians with information regarding patient clinical status. This will increase patient-provider communication and allow for better evaluation and targeting of treatment. Participation in the study will last 4 months. All participants will first undergo initial assessments that will include a telephone interview and a face-to-face interview with a certified study psychiatrist for the purpose of confirming diagnosis. Eligible participants will then be assigned randomly to the LiveWell or TAU group. Participants assigned to either group will be provided with a smartphone and wrist-worn device, and will be asked to carry the phones with them whenever they leave home and to wear the wrist-worn devices 24-hours a day 7 days a week. Participants assigned to the LiveWell intervention will be asked to undergo a 16 week psychosocial intervention consisting of phone-based self-monitoring and educational tools to help them learn skills to better manage symptoms. Participants assigned to the TAU group will be asked to provide limited self-report data on wellness and sleep. All participants, regardless of assigned group, will be asked to participate in assessments delivered over the phone to assess presence and severity of mood symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder, Behavior Therapy, Technology Assisted, Mobile Phone, Smartphone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LiveWell System
Arm Type
Experimental
Arm Description
For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will receive the psychosocial intervention via a smartphone and context-dependent feedback based on self-report and behavioral data. Providers whose patients are randomized to this arm will also be asked to enroll in order to receive information and notifications about patient status for the duration of the study.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will be asked to provide limited self-report data via the phone.
Intervention Type
Behavioral
Intervention Name(s)
LiveWell System
Intervention Description
For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will receive the psychosocial intervention via a smartphone and context-dependent feedback based on self-report and behavioral data. Providers whose patients are randomized to this arm will also be asked to enroll in order to receive information and notifications about patient status for the duration of the study
Primary Outcome Measure Information:
Title
Percent Time Symptomatic
Description
Percent time symptomatic will be assessed using ratings that measure the presence and severity of manic and depressive symptoms.
Time Frame
Participants will be followed for the duration of the 16 week trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of Bipolar Disorder Type I. Minimum of 2 acute episodes in last 2 years. Receiving psychiatric care from a mental health provider willing to receive notifications and information regarding subject symptom status via the LiveWell system. Exclusion Criteria: Not involved in current psychiatric care. Current substance use disorders or other psychiatric diagnosis or symptoms (e.g. dissociate disorder, psychotic symptoms) for which participation in this study is either inappropriate or dangerous. Pregnancy or plans to become pregnant. Visual impairments limiting mobile phone use. An inability to speak and read English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan H. Goulding, MD PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Mobile Behavioral Monitoring Intervention for Bipolar Disorder

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