Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NMP Medical Research Institute | OTHER |
| Croydon Ayurveda Centre | UNKNOWN |
| Active Naturals Limited | UNKNOWN |
| AVP Research Foundation |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group (UCG) | Active Comparator | The usual care control group received care only on hospital wards during episodes |
|
| Ayu Care Group (ACG) | Other | Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ayu-Care | Other | Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach. |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death by Suicide | Death by suicide within 30 days of the index ED visit | From Index ED visit to 30 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neha Sharma | Aarogyam (UK) CIC | Study Director |
| Venkata N Joshi | Croydon Ayurveda Centre | Study Chair |
| Maël Voegeli | AVP Research Foundation | Principal Investigator |
| Skanthesh Lakshmanan | NMP Medical Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyansanjeevani | Jaipur | Rajasthan | India | |||
| NMP Medical Research Institite |
Individual Participants Data will not be available to other researchers. Data will only be shared through publications and presentations on study completion.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000092862 | Psychological Well-Being |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D008515 | Medicine, Ayurvedic |
| ID | Term |
|---|---|
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual-Care | Drug | Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions. |
|
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 |
| Jaipur |
| Rajasthan |
| India |
| D013568 |
| Pathological Conditions, Signs and Symptoms |