An E-health Psychoeducation Program to Manage Symptoms During COVID-19 Pandemic for People With Bipolar Disorders: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder (GAD-7)
研究概览
简要总结
This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic
详细描述
Biological rhythms significantly impact individuals' quality of life (QoL). During the COVID-19 pandemic, social rhythm dysregulation was identified as a contributing factor to relapses in Bipolar Disorder (BD). This trial aims to present data on the efficacy of an e-health psychoeducational intervention for BD in improving anxiety, depressive symptoms, QoL, biological rhythms, and the correlations between QoL and biorhythms.
This study employs a cross-over randomized controlled trial design. Inclusion criteria include a diagnosis of BD according to Diagnostic and Statistical Manual of mental disorders (DSM-V) criteria, age over 18, and obtaining informed consent.
The intervention consists of e-health psychoeducation aimed at reducing distress levels associated with the Covid-19 pandemic and the implemented restrictive measures (lockdown). The focus is on strategies to manage the dysregulation of biological rhythms, with one session per week over two months. Each session lasts approximately an hour and a half and is conducted by a team comprising psychologists, psychiatric rehabilitation technicians, and professional health educators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •diagnosis of BD according to DSM-V, over 18 years old
排除标准
- •do not have bipolar disorder, refusal to participate in the study
研究组 & 干预措施
e-health psychoeducation
干预措施: e-health psychoeducation (Other)
waiting list
结局指标
主要结局
Generalized Anxiety Disorder (GAD-7)
时间窗: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
GAD-7 is 7 item self-administered questionnaire evaluates symptoms of an anxiety disorder
Short Form Health Survey (SF-12)
时间窗: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
SF12 is a self-administered questionnaire consisting of 12 items that assess two dimensions: physical health and mental health to establish poor/good QoL.
Hamilton Depression Rating Scale (HDRS21)
时间窗: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
Depressive symptoms were assessed using HDRS21 consists of 21 items, and the total score allows for the assignment of severity scores for the symptoms
Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN)
时间窗: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
BRIAN is a interview consisting of 18 items that investigate four main areas related to the dysregulation of biological rhythms: sleeping, activity, social rhythms, and eating.
次要结局
未报告次要终点
研究者
Mauro Giovanni Carta
Principal Investigator
University of Cagliari