Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

N/AUnknownNCT05219357

Aarogyam UK92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Psychiatric Disorder

Interventions

Ayu-CareOTHER

Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.

Usual-CareDRUG

Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Gyansanjeevani

Jaipur, Rajasthan, India

NMP Medical Research Institite

Jaipur, Rajasthan, India

Outcomes

Primary Outcomes

Brief Symptom Inventory

Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity

Time frame: 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

Time frame: Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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