NCT02405117

A Mobile Behavioral Monitoring Intervention for Bipolar Disorder

Completed NA Last updated 19 April 2017

What this trial tests

NA trial testing LiveWell System in Bipolar Disorder in 14 participants. Completed in 10 April 2017.

Timeline

10 January 2014

Primary endpoint
10 April 2017

10 April 2017

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	14
Start date	10 January 2014
Primary completion	10 April 2017
Estimated completion	10 April 2017
Sites	1 location across United States

Drugs / interventions tested

• LiveWell System

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Northwestern University

Who can join

Adults 18 to 65, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods.
   Pham Q, Wiljer D, Cafazzo JA. · · 2016 · cited 113× · PMID 27613084 · DOI 10.2196/mhealth.5720
2. A Smartphone-Based Self-management Intervention for Bipolar Disorder (LiveWell): User-Centered Development Approach.
   Jonathan GK, Dopke CA, Michaels T, Bank A, et al · · 2021 · cited 23× · PMID 33843607 · DOI 10.2196/20424
3. Development of Coaching Support for LiveWell: A Smartphone-Based Self-Management Intervention for Bipolar Disorder.
   Dopke CA, McBride A, Babington P, Jonathan GK, et al · · 2021 · cited 9× · PMID 33759798 · DOI 10.2196/25810
4. A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Protocol Development for an Expert System to Provide Adaptive User Feedback.
   Goulding EH, Dopke CA, Michaels T, Martin CR, et al · · 2021 · cited 7× · PMID 34951598 · DOI 10.2196/32932
5. A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial.
   Goulding EH, Dopke CA, Rossom RC, Michaels T, et al · · 2022 · cited 5× · PMID 35188473 · DOI 10.2196/30710