跳至主要内容
临床试验/NCT03508427
NCT03508427终止不适用

Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study

Institut Pasteur3 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年4月12日最近更新:
适应症
干预措施

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

Experimental

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.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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