Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05219357
• Other study ID #: NMP1873-92
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 21, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: January 2022
• Source: Aarogyam UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: January 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Other:
• Ayu-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.

Drug:
• Usual-Care
Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.

Locations

Country	Name	City	State
India	Gyansanjeevani	Jaipur	Rajasthan
India	NMP Medical Research Institite	Jaipur	Rajasthan

Sponsors (5)

Lead Sponsor	Collaborator
Aarogyam UK	Active Naturals Limited, AVP Research Foundation, Croydon Ayurveda Centre, NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death by Suicide	Death by suicide within 30 days of the index ED visit	From Index ED visit to 30 days
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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