Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Severity of depressive symptoms
研究概览
简要总结
Bipolar disorder is a severe psychiatric illness with chronic course and it is associated with high risk of relapse and hospitalisation, and many patients do not recover to their previous psychosocial functioning. Major reasons for poor outcomes are delayed intervention for prodromal mood and behavioural symptoms as well as incomplete treatment responses. Current diagnostic approaches used to assess mood symptoms rely on symptom-based categories, which lack sensitivity to detect subtle mood and behavioural changes. Therefore, the ability to better characterizing bipolar patients may allow to detect possible differences in the illness activity.
On the other hand, there is a growing interest in the potential use of mobile technologies such as mobile apps, smartphone and internet in psychiatric care. Some projects have been testing the potential benefits of mobile apps to assess and treat individuals at-risk or suffering from mood and bipolar disorders, using online signs and symptoms monitoring, yet to the investigators knowledge, none of them have integrated a dimensional approach in a smartphone app to assess mood and behavioural alterations and bipolar illness activity, including subjective and objective data (e.g. physical activity, social activity, etc.).
In this feasibility study the investigators will evaluate the potential relevance of Toi Même app to self-monitoring mood and behavioural changes in bipolar patients with different mood phases compared to the gold-standard mood rating tools used in clinical practice. All patients will be followed for 3 months, with outcome assessments after 2 weeks, after 1 month, 2 months and after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with the current diagnosis of Bipolar disorder type I or type II according to the DSM-5 criteria
- •having an iPhone with iOS version from 9.x with access to wireless Internet connectivity.
排除标准
- •Current DSM-5 diagnosis of schizophrenia, psychotic disorders, dementia, or mental retardation.
- •Active suicidal ideation or behaviours.
研究组 & 干预措施
Toi Même plus treatment as usual
One-Arm study Intervention: Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.
Tool: Toi Même mobile app
干预措施: Daily self-monitoring (Other)
结局指标
主要结局
Severity of depressive symptoms
时间窗: 3 months study period
Changes in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale during the 3 months study period.
Severity of manic symptoms
时间窗: 3 months study period
Changes in manic symptoms measured using the Young Mania Rating Scale during the 3 months study period.
次要结局
- Completion rate(3 months study period.)
- Functional impairment(3 months study period)
- Self-rated manic symptoms(3 months study period)
- Treatment adherence(3 months study period)
- Self-rated depressive symptoms(3 months study period)
- Activation levels(3 months study period)
- Patient acceptance(3 months study period.)
- Movement behavior(3 months study period.)
