Evaluation Of Efficacy Of Smartphone App Based Feedback In The Management Of Generalized Anxiety Disorder :A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- there will be a significant chnages in the ECG patterns of the patient with generalized anxiety disorder and anxiety will not respond with relaxation technique with ECG monitoring
研究概览
简要总结
Despite the well established psychological impact of anxiety the extent and nature of the ECG changes in patient with GENERALIZED ANXIETY DISORDER have not been thoroughly investigated in real word clinical settings therefore the study aims to access ECG patterns in individual diagnosed with GAD using ECG patch monitoring
Currently biofeedback is used in management of anxiety disorder but it is done in hospital setting the use of smartphone based app at home and the application of biofeedback mechanism in anxiety disorder involving monitoring of HRV and providing real time feedback allowing individuals to regulate them voluntarily through relaxation techniques and reduce symptoms of anxiety.
So this study will be the first study to assess a portable form of HRV based biofeedback for management of anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Day(s) 至 39.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with a diagnosis of generalised anxiety disorder based on diagnostic criteria of diagnostic and statistical manual of mental disorders 5th edition age 18-39 yrs patient giving written consent to participate in protocol patient either admitted or staying in dehradun for out patient department patient using smartphone patient willing to download HRV monitoring app patient willing to learn and use relaxation technique for managing anxiety.
排除标准
- •active substance use disorder except caffeine and tobacco or any other preexisting cardiovascular disease family history of cardiovascular disease and history of sudden cardiac death in family history of severe mental disorder as evaluated by detailed history and mental status examination history of unprovoked seizure neoplasm or intracranial surgery or history of severe head injury or cerebrovascular disease patient having significant unstable medical condition like uncontrolled hypertension complicated diabetes mellitus.
结局指标
主要结局
there will be a significant chnages in the ECG patterns of the patient with generalized anxiety disorder and anxiety will not respond with relaxation technique with ECG monitoring
时间窗: baseline,at 2 days,at 2 weeks
次要结局
未报告次要终点
研究者
Dr Sumit Mehta
shri mahant indiresh hospital