LiveWell: A Mobile Intervention for Bipolar Disorder

• ClinicalTrials.gov Identifier: NCT03088462
• Recruitment Status: Completed
• First Posted: March 23, 2017
• Last Update Posted: October 4, 2021
• Sponsor: Northwestern University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Evan Goulding, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder; Bipolar I Disorder	Other: Psychiatric management; Behavioral: Psychosocial treatment; Behavioral: LiveWell Program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: LiveWell: A Mobile Intervention for Bipolar Disorder
• Actual Study Start Date: March 20, 2017
• Actual Primary Completion Date: April 10, 2020
• Actual Study Completion Date: April 10, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status [ Time Frame: 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 :

1. Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity [ Time Frame: 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.

2. Change in Quick Inventory of Depressive Symptomatology-Clinician Rating [ Time Frame: At 0, 8, 16, 24, 32, 40 and 48 weeks ]
   Structured interview designed to assess severity of depression. Scale range is from 0-27.
3. Change in Young Mania Rating Scale [ Time Frame: At 0, 8, 16, 24, 32, 40 and 48 weeks ]
   Structured interview designed to assess severity of mania. Scale range is from 0-60.
4. Change in World Health Organization Quality of Life Scale (BREF) [ Time Frame: 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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Minnesota

HealthPartners Institute

Bloomington, Minnesota, United States, 55425

Sponsors and Collaborators

Northwestern University

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Evan H Goulding, MD/PhD; Northwestern University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Evan Goulding, Assistant Professor, Department of Psychiatry and Behavioral Sciences, Northwestern University
• ClinicalTrials.gov Identifier: NCT03088462
• Other Study ID Numbers: 1R01MH110626 ( U.S. NIH Grant/Contract ); 1R01MH110626 ( U.S. NIH Grant/Contract )
• First Posted: March 23, 2017
• Last Update Posted: October 4, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evan Goulding, Northwestern University:

Bipolar Disorder; Smartphone; Behavior Therapy

Additional relevant MeSH terms:

Disease; Bipolar Disorder; Pathologic Processes; Bipolar and Related Disorders; Mood Disorders; Mental Disorders