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

Tracking Information

• First Submitted Date: March 8, 2017
• First Posted Date: March 23, 2017
• Last Update Posted Date: October 4, 2021
• Actual Study Start Date: March 20, 2017
• Actual Primary Completion Date: April 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2017)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 16, 2017)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: LiveWell: A Mobile Intervention for Bipolar Disorder
• Official Title: LiveWell: A Mobile Intervention for Bipolar Disorder
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Bipolar Disorder
• Bipolar I Disorder

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

Study Arms

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2021): 205
• Original Estimated Enrollment (submitted: March 16, 2017): 200
• Actual Study Completion Date: April 10, 2021
• Actual Primary Completion Date: April 10, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03088462
• Other Study ID Numbers: 1R01MH110626( U.S. NIH Grant/Contract ); 1R01MH110626 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Evan Goulding, Northwestern University
• Original Responsible Party: Same as current
• Current Study Sponsor: Northwestern University
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

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

• PRS Account: Northwestern University
• Verification Date: September 2021