Clinical trial NCT05219357: Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations
Official title: Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis: Pilot Trial Using Community-Based Participatory Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatric Disorder
Keywords: Ayurveda
Mental Health
Emergencies
Community Based Participatory Research
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: NMP Medical Research Institute
name: Croydon Ayurveda Centre
name: Active Naturals Limited
name: AVP Research Foundation
First posted: 2022-02-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brief Symptom Inventory
timeFrame: Change from baseline to 48 hours and 7th-days of intervention
measure: Length of Emergency hospital stay
timeFrame: Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)
Secondary outcomes:
measure: The Kessler Psychological Distress Scale (K10)
timeFrame: Change from baseline to 3rd and 7th-days of intervention
measure: The Psychological Outcome Profiles instrument
timeFrame: From Baseline to 3rd and 7th-days of intervention
measure: Agitation Calmness Evaluation Scale (ACES)
timeFrame: From Baseline to 48 hours and 7th-days of intervention
measure: Positive and Negative Syndrome Scale;
timeFrame: From Baseline to 48 hours and 7th-days of intervention
measure: Satisfaction with acute care
timeFrame: From Baseline to 3rd and 7th-days of intervention
measure: Side effects
timeFrame: From Index ED visit to 30 days
measure: Medication use
timeFrame: From Index ED visit to 30 days
Other outcomes:
measure: Death by Suicide
timeFrame: From Index ED visit to 30 days
Locations:
city: Jaipur
country: India
facility: Gyansanjeevani
state: Rajasthan
city: Jaipur
country: India
facility: NMP Medical Research Institite
state: Rajasthan
Study officials:
affiliation: Aarogyam (UK) CIC
name: Neha Sharma
role: STUDY_DIRECTOR
affiliation: Croydon Ayurveda Centre
name: Venkata N Joshi
role: STUDY_CHAIR
affiliation: AVP Research Foundation
name: Maël Voegeli
role: PRINCIPAL_INVESTIGATOR
affiliation: NMP Medical Research Institute
name: Skanthesh Lakshmanan
role: STUDY_CHAIR
References: