A Mobile Behavioral Monitoring Intervention for Bipolar Disorder

NCT02405117 | Completed DMC

• 1 other identifier: 1R34MH100460
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Behavior Therapy; Technology Assisted; Mobile Phone; Smartphone

Outcome Measures

Primary Outcomes (1)

• Percent Time Symptomatic

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

  Participants will be followed for the duration of the 16 week trial.

Study Arms (2)

LiveWell System

EXPERIMENTAL

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.

Behavioral: LiveWell System

Treatment As Usual

NO INTERVENTION

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.

Interventions

LiveWell System BEHAVIORAL

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

LiveWell System

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Evan H. Goulding, MD PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 1, 2015
• Study Start: January 10, 2014
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)