LiveWell: A Mobile Intervention for Bipolar Disorder
1 other identifier
interventional
205
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2017
CompletedStudy Start
First participant enrolled
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2021
CompletedOctober 4, 2021
September 1, 2021
3.1 years
March 8, 2017
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity
48 weeks
Change in Quick Inventory of Depressive Symptomatology-Clinician Rating
At 0, 8, 16, 24, 32, 40 and 48 weeks
Change in Young Mania Rating Scale
At 0, 8, 16, 24, 32, 40 and 48 weeks
Change in World Health Organization Quality of Life Scale (BREF)
At 0, 24 and 48 weeks
Study Arms (2)
Treatment As Usual
ACTIVE COMPARATORAny treatment for bipolar disorder participant is involved in.
Treatment As Usual + LiveWell Program
EXPERIMENTALTreatment as usual combined with the LiveWell program.
Interventions
Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.
Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.
Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.
Eligibility Criteria
You may qualify if:
- Adults 18-65 years
- Bipolar Disorder Type I
- Minimum of 1 acute episode in the last 2 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern University
Chicago, Illinois, 60611, United States
HealthPartners Institute
Bloomington, Minnesota, 55425, United States
Related Publications (3)
Jonathan GK, Abitante G, McBride A, Bernstein-Sandler M, Babington P, Dopke CA, Rossom RC, Mohr DC, Goulding EH. LiveWell, a smartphone-based self-management intervention for bipolar disorder: Intervention participation and usability analysis. J Affect Disord. 2024 Apr 1;350:926-936. doi: 10.1016/j.jad.2024.01.099. Epub 2024 Jan 19.
PMID: 38246280DERIVEDGoulding EH, Dopke CA, Rossom R, Jonathan G, Mohr D, Kwasny MJ. Effects of a Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder on Relapse, Symptom Burden, and Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Feb 1;80(2):109-118. doi: 10.1001/jamapsychiatry.2022.4304.
PMID: 36542401DERIVEDGoulding 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.
PMID: 35188473DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan H Goulding, MD/PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Psychiatry and Behavioral Sciences
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 23, 2017
Study Start
March 20, 2017
Primary Completion
April 10, 2020
Study Completion
April 10, 2021
Last Updated
October 4, 2021
Record last verified: 2021-09