LiveWell: A Mobile Intervention for Bipolar Disorder

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Bipolar I Disorder
• Intervention / Treatment: Other: Psychiatric management; Behavioral: Psychosocial treatment; Behavioral: LiveWell Program

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 Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartners Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment As Usual; Any treatment for bipolar disorder participant is involved in.	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.
Experimental: Treatment As Usual + LiveWell Program; Treatment as usual combined with the LiveWell program.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Evan H Goulding, MD/PhD, Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): April 10, 2021

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Smartphone; Behavior Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder
• Other Study ID Numbers: 1R01MH110626 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No