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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH110626 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual | Active Comparator | Any treatment for bipolar disorder participant is involved in. |
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| Treatment As Usual + LiveWell Program | Experimental | Treatment as usual combined with the LiveWell program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychiatric management | Other | Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Evan H Goulding, MD/PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| HealthPartners Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38246280 | Derived | 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. | |
| 36542401 | Derived | Goulding 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. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Psychosocial treatment | Behavioral | Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups. |
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| LiveWell Program | Behavioral | Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder. |
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| 48 weeks |
| Change in Quick Inventory of Depressive Symptomatology-Clinician Rating | Structured interview designed to assess severity of depression. Scale range is from 0-27. | At 0, 8, 16, 24, 32, 40 and 48 weeks |
| Change in Young Mania Rating Scale | Structured interview designed to assess severity of mania. Scale range is from 0-60. | At 0, 8, 16, 24, 32, 40 and 48 weeks |
| Change in World Health Organization Quality of Life Scale (BREF) | Structured interview designed to assess physical health, psychological health, social relationships, and environment. Each domain is scored individually with transformed scores of 4-20. | At 0, 24 and 48 weeks |
| Bloomington |
| Minnesota |
| 55425 |
| United States |
| 35188473 | Derived | 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. |