Psychiatric Disorder
Conditions
Keywords
Ayurveda, Mental Health, Emergencies, Community Based Participatory Research
Brief summary
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.
Interventions
OTHERAyu-Care
Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.
DRUGUsual-Care
Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.
Sponsors
NMP Medical Research Institute
Croydon Ayurveda Centre
Active Naturals Limited
AVP Research Foundation
Aarogyam UK
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Emergency hospital stay | 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 |
| Brief Symptom Inventory | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Psychological Outcome Profiles instrument | From Baseline to 3rd and 7th-days of intervention | To measure participant-generated outcomes comprising four items on 6 scale (0-5) 0 = not at all affected' to '5 = severely affected. |
| Agitation Calmness Evaluation Scale (ACES) | From Baseline to 48 hours and 7th-days of intervention | 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) |
| Positive and Negative Syndrome Scale; | From Baseline to 48 hours and 7th-days of intervention | 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) |
| Side effects | From Index ED visit to 30 days | 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) |
| Medication use | From Index ED visit to 30 days | Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual |
| Satisfaction with acute care | From Baseline to 3rd and 7th-days of intervention | 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) |
| The Kessler Psychological Distress Scale (K10) | Change from baseline to 3rd and 7th-days of intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death by Suicide | From Index ED visit to 30 days | Death by suicide within 30 days of the index ED visit |
Countries
India
Outcome results
None listed