Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

Study Overview
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Brief Summary
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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.

Official Title
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Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis: Pilot Trial Using Community-Based Participatory Research

Conditions
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Psychiatric Disorder

Intervention / Treatment
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* Other: Ayu-Care
* Drug: Usual-Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients who have delirium or dementia Prisoners Pediatric patients Elderly patients Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group (UCG)<br>The usual care control group received care only on hospital wards during episodes | Drug: Usual-Care<br>* Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.<br>|
| Other: Ayu Care Group (ACG)<br>Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible. | Other: Ayu-Care<br>* Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.<br>* Other names: Ayurveda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Symptom Inventory | Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity | Change from baseline to 48 hours and 7th-days of intervention | 
| Length of Emergency hospital stay | Length of stay is defined as the time between patient triage and discharge from the emergency department | Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Kessler Psychological Distress Scale (K10) | The K10 comprises 10 items that rate symptoms along the anxiety-depression spectrum, with a five point Likert response, where one is 'none of the time' to five 'all of the time. | Change from baseline to 3rd and 7th-days of intervention | 
| The Psychological Outcome Profiles instrument | To measure participant-generated outcomes comprising four items on 6 scale (0-5) 0 = not at all affected' to '5 = severely affected. | From Baseline to 3rd and 7th-days of intervention | 
| Agitation Calmness Evaluation Scale (ACES) | The ACES consists of a single item that rates overall agitation at the time of patients observations on 9 scale (1=marked agitation, 4=normal behaviour, 9= unarousable) | From Baseline to 48 hours and 7th-days of intervention | 
| Positive and Negative Syndrome Scale; | The tool consists of 5 items: excitement, tension, hostility, being uncooperative, and poor impulse control. Each item is scored on 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme) | From Baseline to 48 hours and 7th-days of intervention | 
| Satisfaction with acute care | Measured on 5-point scale, completed by the participant using the Service Satisfaction Scale 10 (SSS-10), from 1 (No, definitely not) to five (Yes, definitely) | From Baseline to 3rd and 7th-days of intervention | 
| Side effects | The frequency of any side effects or adverse events experienced by individuals to both intervention group on 4 point scale (landing from absent=0 to severe=3) | From Index ED visit to 30 days | 
| Medication use | Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual | From Index ED visit to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Health, Ayurveda, Emergencies, Community Based Participatory Research