| CTRI Number |
CTRI/2025/09/094017 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Using gardening as a treatment for people with psychiatric illness |
|
Scientific Title of Study
|
Gardening as an Occupational Therapy Intervention for Individuals with
Mental Illness: A pilot study in an Indian Long-Term Residential Setting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MITHRA M |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, 3rd Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09677440574 |
| Fax |
|
| Email |
mithra.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Shalini Quadros |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, 3rd Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197579700 |
| Fax |
|
| Email |
shalini.quadros@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinita A Acharya |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, 3rd Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986071111 |
| Fax |
|
| Email |
vinita.acharaya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, Manipal College of Health Professions , Manipal Academy of Higher Education, Manipal, Karnataka 576104
|
|
|
Primary Sponsor
|
| Name |
Manipal college of Health Professions Manipal Academy of Higher Education |
| Address |
Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal,
Udupi
Karnataka - 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mithra M |
Department of Occupational Therapy |
Room Number : 311, Department of Occupational Therapy, 3rd Floor, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Karnataka 576104
Udupi
KARNATAKA |
9677440574
mithra.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F09||Mental disorders due to known physiological conditions, (2) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use, (3) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, (4) ICD-10 Condition: F30-F39||Mood [affective] disorders, (5) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (6) ICD-10 Condition: F50-F59||Behavioral syndromes associated with physiological disturbances and physical factors, (7) ICD-10 Condition: F60-F69||Disorders of adult personality and behavior, (8) ICD-10 Condition: F80-F89||Pervasive and specific developmental disorders, (9) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Outdoor Gardening will be provided as an Occupational Therapy intervention. |
A gardening intervention program will be developed based on existing literature and validated by an
expert panel consisting of a Psychiatrist or Clinical Psychologist or Psychiatric Social , along with three Mental Health Occupational Therapists. The finalized protocol will be submitted to the IEC for
review and implemented after receiving IEC approval.
Eligible participants will be identified based on the Participants interest at Hombelaku Psychiatric Rehabilitation Centre following consultation with the treating team.
Individuals meeting the inclusion criteria will be informed about the studys objectives, procedures,
potential benefits, and risks. Written informed consent will be obtained prior to participation.
Baseline data, including demographic details, will be collected using the scales World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Ottawa–Georgia Mood Scale (OMS), Vellore Occupational Therapy Evaluation Scale (VOTES), Montreal Cognitive Assessment (MoCA). The validated gardening intervention will then be implemented, with data collection
scheduled at baseline, mid-intervention (week 4), and post-intervention (week 8). The OMS will be administered after each session to assess changes in participants’ emotional states.
Qualitative feedback on participants’ experiences will be gathered at weeks 4 and 8.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with mental illness currently residing in Hombelaku, for at least a month
at the time of recruitment
Individuals scoring within the range of 4 to 5 in Clinical Global Impression Scale – Severity
(CGI-S).
Individuals aged 18 years and above.
|
|
| ExclusionCriteria |
| Details |
Individuals with any observed physical disabilities interfering with the gardening activity
Individuals exhibiting suicidal ideation and aggressive behavior as per the decision of the
treating team.
Individuals in their acute phase of recovery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functioning,
Quality of Life,
Mood and
Cognition |
End of fourth week after the implementation of the intervention and End of eighth week after the implementation of the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This pilot interventional study aims to evaluate the feasibility and preliminary effectiveness of gardening as an occupational therapy intervention for individuals with mental illness residing in a long-term residential care facility in India. The primary outcomes include changes in quality of life, mood, cognition, and occupational functioning. Gardening has been widely recognized internationally as a therapeutic modality with benefits for mental health and psychosocial well-being. However, there is a lack of interventional research conducted within Indian residential rehabilitation settings, despite the cultural relevance of gardening and its potential to promote meaningful engagement and recovery. This study therefore seeks to address this gap by generating locally applicable evidence to inform occupational therapy practice and mental health rehabilitation in India. |