Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Daily self-reported mood instability via Monsenso
研究概览
简要总结
The Smart Bipolar RCT is a pragmatic RCT aiming to investigate effects of smartphone-based add on treatment in large scale clinical practice (N= 200 patients).
详细描述
Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed, and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. IT solutions have during recent years emerged as a possible way to optimize treatment, but the effects of digital health interventions are rarely investigated scientifically in health care services.
This is an application from the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region. The Smart Bipolar randomized controlled trial is a pragmatic trial aiming to investigate the effects of smartphone-based add-on treatment in large-scale clinical practice (N= 200 patients). Findings from the study will have a great impact on future IT monitoring and treatment in bipolar disorder.
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
- None
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
- •All patients in CAG Bipolar, i.e., with a main diagnosis of bipolar disorder in the five large centers, in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hilleroed, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup)
排除标准
- 未提供
结局指标
主要结局
Daily self-reported mood instability via Monsenso
时间窗: During the entire study period of 6 months per participant
Mood measured daily via smartphones on a scale form -3 to +3.
次要结局
- Risk of psychiatric hospitalization(During the entire study period of 6 months per participant)
- Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania(Baseline and 6 months)
- Perceived stress according to Cohen's Perceived stress scale(Baseline and 6 months)
- Cumulated duration of psychiatric hospitalization(During the entire study period of 6 months per participant)
- Quality of life according to WHO Quality of Life-BREF(Baseline and 6 months)
- Patient-evaluated depressive symptoms according to the Major Depressive Inventory(Baseline and 6 months)
- Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder(Baseline and 6 months)
- Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine and the use of antidepressants(During the entire study period of 6 months)
研究者
Lars Vedel Kessing
Prof., Principal Investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital