| CTRI Number |
CTRI/2026/02/102710 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Social and Cultural Factors on Regular Treatment Taking among Patients Attending a Mental Health Clinic |
|
Scientific Title of Study
|
Impact of sociocultural parameters in treatment compliance in patients presenting to psychiatric clinic cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShivaniben Patel |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of psychiatry,AVBRH Campus,Sawangi Meghe,wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9429921420 |
| Fax |
|
| Email |
shivupatel990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRagini Patil |
| Designation |
Proffessor and Head of department ,psychiatry |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of psychiatry,AVBRH Campus,Sawangi Meghe,wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096136123 |
| Fax |
|
| Email |
ragini.tushar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRagini Patil |
| Designation |
Proffessor and Head of department ,psychiatry |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of psychiatry,AVBRH Campus,Sawangi Meghe,wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096136123 |
| Fax |
|
| Email |
ragini.tushar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahallal Nehru Medical College,Sawangi Meghe,Wardha 442001,Maharastra,India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education And Research |
| Address |
Sawangi Meghe,Wardha.442001,Maharastra,India |
| 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 |
| DrShivaniben Patel |
Jawaharlal Nehru Medical College |
Sawangi Meghe, Wardha ,442001,Maharastra,India
Wardha
MAHARASHTRA |
9429921420
shivupatel990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institude Of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. All Patients in age of 6 to 75 years presenting to psychiatric opd.
2. Patient giving written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects not giving written informed consent.
2. Patients who are acutely medical and surgically ill or not able to cooperate with the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the pattern of psychiatric disorders and sociodemographic factors, along with treatment compliance in patients presenting to the psychiatric outpatient department in rural hospital. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="297"
Sample Size from India="297"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2026 |
| 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 Applicable |
| 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 hospital-based cross-sectional study aims to assess the impact of sociocultural parameters on treatment compliance among patients attending the psychiatric outpatient department of a rural tertiary care hospital. Patients aged 6–75 years who provide written informed consent will be included, while those unwilling or unable to cooperate due to acute medical or surgical illness will be excluded. Sociodemographic details will be recorded using a structured proforma, and psychiatric diagnoses will be made as per ICD-11 criteria. Treatment compliance will be assessed using the Medication Adherence Rating Scale (MARS). The study objectives are to evaluate the pattern of psychiatric disorders, assess treatment adherence, and analyze the association between sociocultural factors and treatment compliance.
|