NCT03088462

LiveWell: A Mobile Intervention for Bipolar Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

LiveWell is a study evaluating the use of smartphones to better understand and improve the treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions and improve their effectiveness in reducing symptoms and preventing mood episodes.

Detailed description

A single blind, randomized controlled trial (N = 200, 2:3 ratio of usual care vs usual care and intervention) will be conducted in clinical practices around Chicago and Minneapolis. Eligible participants are adult bipolar 1 disorder patients not experiencing a current mood episode with a history of at least one acute episode in the last two years who are in treatment with a psychiatrist. The primary clinical outcome will be time to relapse, and the secondary outcomes will be percent time symptomatic, symptom severity, and quality of life. Participation in the study lasts for 12 months. Participants are asked to carry a smartphone with them whenever they leave home and wear a wristwatch for measuring activity all day every day. Participants are also asked to complete a series of telephone assessments and may be asked to complete daily check-ins on a smartphone and work with a health coach. Participants will need to attend two in-person clinic visits at 680 N Lake Shore Drive, Chicago IL 60611 Suite 1520 or at 3311 E Old Shakopee Rd, Bloomington, MN 55425.

Conditions

• Bipolar Disorder
• Bipolar I Disorder

Interventions

Type	Name	Description
OTHER	Psychiatric management	Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.
BEHAVIORAL	Psychosocial treatment	Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.
BEHAVIORAL	LiveWell Program	Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.

Timeline

• Start date: 2017-03-20
• Primary completion: 2020-04-10
• Completion: 2021-04-10
• First posted: 2017-03-23
• Last updated: 2021-10-04

Locations

2 sites across 1 country: United States