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LiveWell: A Mobile Intervention for Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088462
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : October 4, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Evan Goulding, 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.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088462


Locations
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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
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Principal Investigator: Evan H Goulding, MD/PhD Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders