Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

Not Applicable

• Conditions: Psychiatric Disorder
• Interventions: Drug: Usual-Care; Other: Ayu-Care

• Registration Number: NCT05219357
• Lead Sponsor: Aarogyam UK

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-21
• Primary Completion: 2021-12-30
• Status Verified: 2022-01
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Study Completion: 2022-01-30
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Group (UCG)	Usual-Care	The usual care control group received care only on hospital wards during episodes
Ayu Care Group (ACG)	Ayu-Care	Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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)
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)
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.
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)
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

Trial Locations

Locations (2)

Gyansanjeevani; 🇮🇳 Jaipur, Rajasthan, India

NMP Medical Research Institite; 🇮🇳 Jaipur, Rajasthan, India