Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychiatric Disorder
• Intervention / Treatment: Drug: Usual-Care; Other: Ayu-Care

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India
      • Gyansanjeevani
    • Jaipur, Rajasthan, India
      • NMP Medical Research Institite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care Group (UCG); The usual care control group received care only on hospital wards during episodes	Drug: Usual-Care; Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.
OTHER: Ayu Care Group (ACG); 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; Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.; Other Names: Ayurveda

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aarogyam UK
• Collaborators: NMP Medical Research Institute; Croydon Ayurveda Centre; Active Naturals Limited; AVP Research Foundation
• Investigators: Study Director: Neha Sharma, Aarogyam (UK) CIC; Study Chair: Venkata N Joshi, Croydon Ayurveda Centre; Principal Investigator: Maël Voegeli, AVP Research Foundation; Study Chair: Skanthesh Lakshmanan, NMP Medical Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2021
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ANTICIPATED): January 30, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (ACTUAL): February 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Mental Health; Community Based Participatory Research; Emergencies; Ayurveda
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: NMP1873-92

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participants Data will not be available to other researchers. Data will only be shared through publications and presentations on study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No