LiveWell: A Mobile Intervention for Bipolar Disorder

Northwestern University

Status: Completed

Conditions: Bipolar I Disorder; Bipolar Disorder

Treatments: Behavioral: LiveWell Program; Behavioral: Psychosocial treatment; Other: Psychiatric management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03088462

1R01MH110626 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18-65 years
• Bipolar Disorder Type I
• Minimum of 1 acute episode in the last 2 years

Exclusion criteria

• Not receiving psychiatric care
• Current mood episode
• Current substance use disorder (within the last 3 months)
• Current severe suicidal ideation or a recent serious suicide attempt (within the last 3 months)
• Inability to speak and read English
• Visual, hearing, voice, cognitive or motor impairment that would prevent completion of study and treatment procedures

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 2 patient groups

Treatment As Usual

Active Comparator group

Description:

Any treatment for bipolar disorder participant is involved in.

Treatment:

Other: Psychiatric management

Behavioral: Psychosocial treatment

Treatment As Usual + LiveWell Program

Experimental group

Description:

Treatment as usual combined with the LiveWell program.

Treatment:

Other: Psychiatric management

Behavioral: LiveWell Program

Behavioral: Psychosocial treatment