Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis: Pilot Trial Using Community-Based Participatory Research
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Brief Symptom Inventory
研究概览
简要总结
For patients undergoing a psychiatric crisis, hospitalisation is required. In developing countries specially in sub-urban or rural areas, most patients don't access intensive care. In India, AYUSH system of medical care is widely used, including crisis resolution and community treatment have been widely implemented in various mental health systems. However, evidence to support their effectiveness has remained very low.
Present study is designed as community based participatory research, where Ayurveda treatment , a short-term, specialised, crisis intervention is provided by community outreach team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with a psychiatric complaint.
- •Male or female patients at least 18 years of age.
- •Each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment.
排除标准
- •Patients who have delirium or dementia
- •Prisoners
- •Pediatric patients
- •Elderly patients
- •Pregnancy or breastfeeding
研究组 & 干预措施
Usual Care Group (UCG)
The usual care control group received care only on hospital wards during episodes
干预措施: Usual-Care (Drug)
Ayu Care Group (ACG)
Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible.
干预措施: Ayu-Care (Other)
结局指标
主要结局
Brief Symptom Inventory
时间窗: Change from baseline to 48 hours and 7th-days of intervention
Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity
Length of Emergency hospital stay
时间窗: Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)
Length of stay is defined as the time between patient triage and discharge from the emergency department
次要结局
- Side effects(From Index ED visit to 30 days)
- The Psychological Outcome Profiles instrument(From Baseline to 3rd and 7th-days of intervention)
- Agitation Calmness Evaluation Scale (ACES)(From Baseline to 48 hours and 7th-days of intervention)
- Satisfaction with acute care(From Baseline to 3rd and 7th-days of intervention)
- The Kessler Psychological Distress Scale (K10)(Change from baseline to 3rd and 7th-days of intervention)
- Positive and Negative Syndrome Scale;(From Baseline to 48 hours and 7th-days of intervention)
- Medication use(From Index ED visit to 30 days)