LiveWell: A Mobile Intervention for Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 4
- 主要终点
- Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years
- •Bipolar Disorder Type I
- •Minimum of 1 acute episode in the last 2 years
排除标准
- •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.
结局指标
主要结局
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status
时间窗: 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).
次要结局
- Change in World Health Organization Quality of Life Scale (BREF)(At 0, 24 and 48 weeks)
- 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)
研究者
Evan Goulding
Assistant Professor, Department of Psychiatry and Behavioral Sciences
Northwestern University