LiveWell: A Mobile Intervention for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

LiveWell: A Mobile Intervention for Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088462
• Other study ID #: 1R01MH110626
• Secondary ID: 1R01MH110626
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: April 10, 2021

Study information

• Verified date: September 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 10, 2021
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder
• Disease

Intervention

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.
• LiveWell Program
Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.

Locations

Country	Name	City	State
United States	HealthPartners Institute	Bloomington	Minnesota
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status	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).	Up to 48 weeks
Secondary	Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity	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.	48 weeks
Secondary	Change in Quick Inventory of Depressive Symptomatology-Clinician Rating	Structured interview designed to assess severity of depression. Scale range is from 0-27.	At 0, 8, 16, 24, 32, 40 and 48 weeks
Secondary	Change in Young Mania Rating Scale	Structured interview designed to assess severity of mania. Scale range is from 0-60.	At 0, 8, 16, 24, 32, 40 and 48 weeks
Secondary	Change in World Health Organization Quality of Life Scale (BREF)	Structured interview designed to assess physical health, psychological health, social relationships, and environment. Each domain is scored individually with transformed scores of 4-20.	At 0, 24 and 48 weeks