Daily Electronic Monitoring of Subjective and Objective Measures of Illness Activity in Bipolar Disorder - The MONARCA II Trial (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Differences between the groups in depressive and manic symptoms and the number of affective episodes
研究概览
简要总结
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. Major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment.
Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled trial, to test the effect of daily reporting of subjective self-monitoring of depressive and manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.
In the MONARCA II trial the investigators will develop and deploy a new version of the smartphone based monitoring system. The investigators will in a randomized controlled single blind trial investigate whether daily electronic monitoring of subjective and objective measures of illness activity using a smartphone based self-monitoring system including feedback on subjective as well as automatically generated objective data (e.g.social activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive and manic symptoms and improves functioning more than a control group receiving a smartphone. All patients will be followed for 9 months with outcome assessments at baseline, after 4 weeks, after 3 months, after 6 months and after 9 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bipolar Disorder according to SCAN interview
- •≥18 years of age
- •Patients who previously have received a course of treatment at the Clinic for Affective Disorders, Psychiatric Centre Copenhagen, Denmark
排除标准
- •Pregnancy
- •Lack of Danish language skills
- •Patients who previously have received and used the MONARCA I system for self-monitoring
研究组 & 干预措施
Non-MONARCA II system
Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
干预措施: Non-MONARCA II system (Device)
The MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
干预措施: The MONARCA II system (Device)
结局指标
主要结局
Differences between the groups in depressive and manic symptoms and the number of affective episodes
时间窗: Baseline and up to 9 months
Differences between the groups in depressive and manic symptoms measured using Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS) and episodes defined ad HDRS\<= 14 and/or YMRS\<= 14
次要结局
- Differences between the groups in functioning(Baseline up to 9 months follow up)
- Differences between the groups in perceived stress(Baseline up to 9 months)
- Differences between the groups in quality of life(Baseline up to 9 months follow up)
- Differences between the groups in self-rated depressive symptoms(Baseline up to 9 months)
- Differences between the groups in smartphone measures(Baseline and up to 9 months)
- Differences between the groups in number of hospitalizations(Baseline up to 9 months follow up)
- Differences between the groups in number of contacts to clinicians and emergency rooms(Baseline up to 9 months follow up)
- Differences in self-rated manic symptoms(Baseline up to 9 months follow up)
- Differences between the groups in adherence to medication(Baseline up to 9 months follow up)
- Differences between the groups in recovery(Baseline up to 9 months follow up)
- Differences between the groups in empowerment(baseline up ot 9 months)
研究者
Maria Faurholt-Jepsen
Principal Investigator, MD and PhD student
Psychiatric Centre Rigshospitalet