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CTRI Number  CTRI/2025/11/097413 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding Reflective Functioning and Epistemic Trust among individuals with Depression 
Scientific Title of Study   Role of reflective functioning on epistemic trust among individuals with depressive disorders  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NAZREEN S M 
Designation  MPhil Clinical Psychology Trainee 
Affiliation  Manipal College of Health Profession 
Address  Department of Clinical Psychology Manipal College of Health Profession Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  09446037407  
Fax    
Email  nazreen.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishalee S 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Profession 
Address  Department of Clinical Psychology Manipal College of Health Profession Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9488615322  
Fax    
Email  vaishalee.s@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms Samyukta Vaidyanathan 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Profession 
Address  Department of Clinical Psychology Manipal College of Health Profession Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  8939372782  
Fax    
Email  samyukta.v@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Udupi,Karnataka, India 576104 
 
Primary Sponsor  
Name  Nazreen S M 
Address  Department of Clinical Psychology Manipal College of Health Profession Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishalee S  Department of Clinical Psychology   Manipal College of Health Profession Manipal Academy of Higher Education
Udupi
KARNATAKA 		 9488615322

vaishalee.s@manipal.edu 
Dr Sonia Shenoy  Department of Psychiatry  Kasturba Medical college Manipal Academy of Higher Education 576104
Udupi
KARNATAKA 		 984405794

sonia.shenoy@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: MANA-SANTAPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All genders

Aged between 18 and 50 years.

Functional fluency in English or Kannada

Diagnosis of a Single depressive episode, Recurrent depressive disorder or Dysthymia as ICD-11 criteria 
 
ExclusionCriteria 
Details  Clients with severe depression

Comorbid severe psychiatric conditions.

Comorbid substance use or Personality disorders.

Patients who have undergone more than five structured psychotherapies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Epistemic Trust
Epistemic Mistrust
Epistemic Credulity
 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Reflective Functioning
Hypomentalizing
Hypermentalizing
 		 At baseline 
 
Target Sample Size   Total Sample Size="151"
Sample Size from India="151" 
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)   10/12/2025 
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="9"
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   3. Aims & objectives:
To study the role of reflective functioning on epistemic trust among adults diagnosed with depressive disorders
To assess the role of reflective functioning on epistemic trust in individuals with depressive disorders.
To assess the role of reflective functioning on epistemic trust in healthy adults
To examine the difference in reflective functioning and epistemic trust between individuals with depression and healthy adults

After registering the study with the Clinical Trial Registry of India, data collection will commence. Recruitment of healthy adults will occur via flyers posted across the MAHE campus—these will include the study’s title, objectives, inclusion criteria, and researcher contact details only those scoring below 20 on the K10 will be eligible for the healthy adult group. Flyers with similar information will also be distributed at the Clinical Psychology and Psychiatry outpatient departments at Kasturba Medical College, Manipal, to recruit individuals with depression. Eligible individuals in both groups (i.e., persons with depression identified via OPD and healthy adults with K10 < 20) will then receive detailed study information and be invited to provide informed consent. Upon obtaining written consent, all participants will complete self-report measures including the Certainty about Mental States Questionnaire and the Epistemic Trust, Mistrust, and Credulity Questionnaire with an expected completion time of approximately 30–40 minutes.   
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