| CTRI Number |
CTRI/2025/10/096044 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Diagnosis of Anxiety, Depression and Stress in Adult patients with Chronic Diseases such as Hypertension, Diabetes, Asthma, Tuberculosis, Chronic Obstructive Pulmonary Disorder, Chronic Liver Diseases, Chronic Kidney Diseases, etc. attending selected Primary Health Centres |
|
Scientific Title of Study
|
Screening for Anxiety, Depression, and Stress among Patients with Chronic Diseases visiting Selected Primary Health Centres (PHCs) – A 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 |
Dr Ramesh Bhandari |
| Designation |
Assisstant Professor |
| Affiliation |
KLE College of Pharmacy Belagavi |
| Address |
Room No. 15, Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9591452418 |
| Fax |
|
| Email |
ramesh_2417@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Bhandari |
| Designation |
Assisstant Professor |
| Affiliation |
KLE College of Pharmacy |
| Address |
Room No. 15, Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9591452418 |
| Fax |
|
| Email |
ramesh_2417@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prerna Ostwal |
| Designation |
Student |
| Affiliation |
KLE College of Pharmacy |
| Address |
Room No 15, Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7020906390 |
| Fax |
|
| Email |
adsproject2526@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi-590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KLE College of Pharmacy |
| Address |
Nehru Nagar, Belagavi-590010, Karnataka |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Bhandari |
Ashok Nagar Primary Health Centre |
Ashok Nagar, Shivaji Nagar, Belagavi-590016
Belgaum
KARNATAKA |
09591452418
ramesh_2417@yahoo.com |
| Dr Ramesh Bhandari |
Rukmini Nagar Primary Health Centre |
Rukmini Nagar, Mahantesh Nagar, Belagavi- 590017
Belgaum
KARNATAKA |
09591452418
ramesh_2417@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| klecopbgm ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E08-E13||Diabetes mellitus, (3) ICD-10 Condition: J45||Asthma, (4) ICD-10 Condition: N18||Chronic kidney disease (CKD), (5) ICD-10 Condition: K70-K77||Diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years, of both genders and diagnosed with chronic non-communicable diseases like T2DM, HTN, Asthma, Cardiovascular diseases, chronic respiratory diseases, chronic kidney diseases, and chronic liver disorder suffering from at least 6 months prior to study.
2. Patients with one or more comorbidities.
3. Patients attending either of the two selected PHCs
4. Patients willing to participate |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactating women.
2. Patients diagnosed with terminally ill, end stage diseases.
3. Patients already diagnosed with mental health disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of anxiety, depression and stress among adults with chronic diseases visiting selected primary health centres using diagnostic tools. |
Diagnosis should be confirmed atleast 6 months prior to the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess quality of life of patients with chronic diseases.
|
Diagnosis should be confirmed atleast 6 months prior to the study. |
| To assess the stigma around mental health problems among chronic disease patients. |
Nil |
|
|
Target Sample Size
|
Total Sample Size="383"
Sample Size from India="383"
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)
|
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="0"
Months="6"
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
|
The study emphasizes the critical need to integrate mental health care into the management of chronic diseases, particularly in low- and middle-income countries like India. Mental health disorders such as anxiety and depression are common among individuals with chronic conditions like diabetes, hypertension, and cardiovascular disease, significantly impacting their overall health outcomes and quality of life. Despite the high prevalence, mental health screening is often neglected in primary health centres (PHCs), where most patients seek initial care. This oversight leads to delayed diagnoses, poor treatment adherence, and worsened physical health. The study advocates for routine mental health screening in PHCs to address this gap, promote early intervention, and improve patient outcomes through holistic care. |