ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03088462
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Evan Goulding, Northwestern University

March 8, 2017
March 23, 2017
August 22, 2018
March 20, 2017
April 28, 2020   (Final data collection date for primary outcome measure)
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).

Same as current
Complete list of historical versions of study NCT03088462 on ClinicalTrials.gov Archive Site
  • 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.

  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
LiveWell: A Mobile Intervention for Bipolar Disorder
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Bipolar I Disorder
  • 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.
  • Active Comparator: Treatment As Usual
    Any treatment for bipolar disorder participant is involved in.
    Interventions:
    • Other: Psychiatric management
    • Behavioral: Psychosocial treatment
  • Experimental: Treatment As Usual + LiveWell Program
    Treatment as usual combined with the LiveWell program.
    Interventions:
    • Other: Psychiatric management
    • Behavioral: Psychosocial treatment
    • Behavioral: LiveWell Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
July 31, 2020
April 28, 2020   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Evan H Goulding, MD/PhD 312-503-9095 livewell@northwestern.edu
United States
 
 
NCT03088462
1R01MH110626( U.S. NIH Grant/Contract )
1R01MH110626 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Evan Goulding, Northwestern University
Northwestern University
National Institute of Mental Health (NIMH)
Principal Investigator: Evan H Goulding, MD/PhD Northwestern University
Northwestern University
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP