LiveWell: A Mobile Intervention for Bipolar Disorder

Not Applicable

Completed

• Conditions: Bipolar Disorder; Bipolar I Disorder
• Interventions: Other: Psychiatric management; Behavioral: Psychosocial treatment; Behavioral: LiveWell Program

• Registration Number: NCT03088462
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-16
• Study Start: 2017-03-20
• Study First Posted: 2017-03-23
• Primary Completion: 2020-04-10
• Study Completion: 2021-04-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment As Usual + LiveWell Program	Psychosocial treatment	Treatment as usual combined with the LiveWell program.
Treatment As Usual	Psychiatric management	Any treatment for bipolar disorder participant is involved in.
Treatment As Usual	Psychosocial treatment	Any treatment for bipolar disorder participant is involved in.
Treatment As Usual + LiveWell Program	Psychiatric management	Treatment as usual combined with the LiveWell program.
Treatment As Usual + LiveWell Program	LiveWell Program	Treatment as usual combined with the LiveWell program.

Primary Outcome Measures

Name	Time	Method
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status	Up to 48 weeks	Semi-structured interview designed to assess clinical status allowing determination of time to relapse (onset of a mood episode).; Clinical Status: episode = depression, mania, hypomania, mixed; continued symptomatic (≥ 3 moderate symptoms without recovery), recovering (≤ 2 moderate symptoms, ≤ 8 weeks), prodromal (≥ 3 moderate symptoms after recovery); recovered (≤ 2 moderate symptoms, ≥ 8 weeks).

Secondary Outcome Measures

Name	Time	Method
Change in World Health Organization Quality of Life Scale (BREF)	At 0, 24 and 48 weeks	Structured interview designed to assess physical health, psychological health, social relationships, and environment. Each domain is scored individually with transformed scores of 4-20.
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity	48 weeks	Semi-structured interview designed to assess symptom severity allowing determination of percent time symptomatic (time with psychiatric status rating \> 1.5).; Psychiatric Status Rating: Syndromal Symptoms - 6 = definite criteria with psychotic symptoms or extreme impairment, 5 = definite criteria without psychotic symptoms or extreme impairment; Subsyndromal Symptoms - 4 = not definite criteria but major symptoms or major impairment, 3 = ≥ 3 moderate symptoms, moderate impairment, 2 = ≤ 2 moderate criteria symptoms, minimal impairment; Asymptomatic:1.5 = ≥ 1 mild but no moderate criteria symptoms; 1 = no mild or moderate criteria symptoms.
Change in Quick Inventory of Depressive Symptomatology-Clinician Rating	At 0, 8, 16, 24, 32, 40 and 48 weeks	Structured interview designed to assess severity of depression. Scale range is from 0-27.
Change in Young Mania Rating Scale	At 0, 8, 16, 24, 32, 40 and 48 weeks	Structured interview designed to assess severity of mania. Scale range is from 0-60.

Trial Locations

Locations (2)

HealthPartners Institute; 🇺🇸 Bloomington, Minnesota, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States