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Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

Primary Purpose

Psychiatric Disorder

Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Ayu-Care
Usual-Care
Sponsored by
Aarogyam UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychiatric Disorder focused on measuring Ayurveda, Mental Health, Emergencies, Community Based Participatory Research

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gyansanjeevani
  • NMP Medical Research Institite

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Usual Care Group (UCG)

Ayu Care Group (ACG)

Arm Description

The usual care control group received care only on hospital wards during episodes

Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible.

Outcomes

Primary Outcome Measures

Brief Symptom Inventory
Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity
Length of Emergency hospital stay
Length of stay is defined as the time between patient triage and discharge from the emergency department

Secondary Outcome Measures

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.
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.
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)
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)
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)
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)
Medication use
Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual

Full Information

First Posted
January 6, 2022
Last Updated
January 20, 2022
Sponsor
Aarogyam UK
Collaborators
NMP Medical Research Institute, Croydon Ayurveda Centre, Active Naturals Limited, AVP Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05219357
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarogyam UK
Collaborators
NMP Medical Research Institute, Croydon Ayurveda Centre, Active Naturals Limited, AVP Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder
Keywords
Ayurveda, Mental Health, Emergencies, Community Based Participatory Research

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group (UCG)
Arm Type
Active Comparator
Arm Description
The usual care control group received care only on hospital wards during episodes
Arm Title
Ayu Care Group (ACG)
Arm Type
Other
Arm Description
Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible.
Intervention Type
Other
Intervention Name(s)
Ayu-Care
Other Intervention Name(s)
Ayurveda
Intervention Description
Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.
Intervention Type
Drug
Intervention Name(s)
Usual-Care
Intervention Description
Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.
Primary Outcome Measure Information:
Title
Brief Symptom Inventory
Description
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
Title
Length of Emergency hospital stay
Description
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 Outcome Measure Information:
Title
The Kessler Psychological Distress Scale (K10)
Description
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
Title
The Psychological Outcome Profiles instrument
Description
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
Title
Agitation Calmness Evaluation Scale (ACES)
Description
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
Title
Positive and Negative Syndrome Scale;
Description
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)
Time Frame
From Baseline to 48 hours and 7th-days of intervention
Title
Satisfaction with acute care
Description
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)
Time Frame
From Baseline to 3rd and 7th-days of intervention
Title
Side effects
Description
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)
Time Frame
From Index ED visit to 30 days
Title
Medication use
Description
Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual
Time Frame
From Index ED visit to 30 days
Other Pre-specified Outcome Measures:
Title
Death by Suicide
Description
Death by suicide within 30 days of the index ED visit
Time Frame
From Index ED visit to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma
Organizational Affiliation
Aarogyam (UK) CIC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Venkata N Joshi
Organizational Affiliation
Croydon Ayurveda Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maël Voegeli
Organizational Affiliation
AVP Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Skanthesh Lakshmanan
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Gyansanjeevani
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
NMP Medical Research Institite
City
Jaipur
State/Province
Rajasthan
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participants Data will not be available to other researchers. Data will only be shared through publications and presentations on study completion.

Learn more about this trial

Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

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