Clinical trial NCT03088462: LiveWell: A Mobile Intervention for Bipolar Disorder
Official title: LiveWell: A Mobile Intervention for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Bipolar I Disorder
Keywords: Bipolar Disorder
Smartphone
Behavior Therapy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-03-23
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity
timeFrame: 48 weeks
measure: Change in Quick Inventory of Depressive Symptomatology-Clinician Rating
timeFrame: At 0, 8, 16, 24, 32, 40 and 48 weeks
measure: Change in Young Mania Rating Scale
timeFrame: At 0, 8, 16, 24, 32, 40 and 48 weeks
measure: Change in World Health Organization Quality of Life Scale (BREF)
timeFrame: At 0, 24 and 48 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Bloomington
country: United States
facility: HealthPartners Institute
state: Minnesota
Study officials:
affiliation: Northwestern University
name: Evan H Goulding, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goulding EH, Dopke CA, Rossom RC, Michaels T, Martin CR, Ryan C, Jonathan G, McBride A, Babington P, Bernstein M, Bank A, Garborg CS, Dinh JM, Begale M, Kwasny MJ, Mohr DC. 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. JMIR Res Protoc. 2022 Feb 21;11(2):e30710. doi: 10.2196/30710.