Future Internet Social and Technological Alignment Research (FISTAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Functioning Assessment Short Test (FAST)
研究概览
简要总结
Bipolar disorder patients frequently presents recurring episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low quality of life, relapses of disease and recurring hospitalization. Early diagnosis and appropriate intervention may play a role in preventing the neuroprogressive course of bipolar illness. The new technologies represent an opportunity to develop psychological standardized treatments using internet devices that minimizing the limitations of face to face treatments because of its accessibility that allow adjusting to the availability of each user. However, although exist many online psychological programs through web and mobile devices for bipolar disorder, there is not evidence about their efficacy and effectiveness due to the variability in measures and methodology used.
详细描述
Future Internet Social and Technological Alignment Research (FI-STAR) clinical trial is a randomized simple blind evaluation within an European project. FISTAR is developed to compare this technical solution with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two treatment groups: 1) the experimental group (tele-care support) and the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a diagnosis of bipolar disorder.
- •Being aged between 18-50 years.
- •Being in remission (euthymic state).
- •Being familiarity with new technologies (computer and /or smartphone).
- •Being treatment in the mental health network of the Basque Country (Osakidetza).
排除标准
- •Having listening, reading or writing problems.
- •Having a diagnosis of mental retardation.
- •Unavailability of a smartphone.
- •Having manic or depressive symptomatology at the time of inclusion (HAMD> 16 and YOUNG> 8).
- •Having suicidal ideation.
结局指标
主要结局
Functioning Assessment Short Test (FAST)
时间窗: baseline-9 weeks
To analyze the effectiveness of a psychoeducation treatment based on telemedicine versus usual treatment in relation with better functional outcome of bipolar disorder measured by Functioning Assessment Short Test.
次要结局
- Beck Depression Inventory (BDI-II)(baseline-9 weeks)
- State-Trait Anxiety Inventory (STAI)(baseline-9 weeks)
- Young Mania Rating Scale (YMRS)(baseline-9 weeks)
- Treatment dropout rate(baseline-9 weeks)
研究者
Ana María González-Pinto
Medical Doctor
Basque Health Service