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CTRI Number  CTRI/2023/08/056944 [Registered on: 25/08/2023] Trial Registered Prospectively
Last Modified On: 26/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Suicidal behavioral for university students 
Scientific Title of Study   Behavioral predictors of Anxiety, Depression and Suicidal Ideation for the students of Jashore University of Science & Technology  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ahamadullah Hil Galeb 
Designation  Student 
Affiliation  Jashore University of Science and Technology 
Address  Room no 304, Department of Physiotherapy and Rehabilitation, Dr. M R Khan medical center, Jashore University of Science and Technology, Jashore, Bangladesh.



7408
Other 
Phone  8801778633732  
Fax    
Email  mailtogaleb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K M Amran Hossain  
Designation  Lecturer  
Affiliation  Jashore University of Science and Technology 
Address  Room no 304, Department of Physiotherapy and Rehabilitation, Dr. M R Khan medical center, Jashore University of Science and Technology, Jashore, Bangladesh.



7408
Other 
Phone  8801735661492  
Fax    
Email  amranphysio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. K M Amran Hossain  
Designation  Lecturer  
Affiliation  Jashore University of Science and Technology 
Address  Room no 304, Department of Physiotherapy and Rehabilitation, Dr. M R Khan medical center, Jashore University of Science and Technology, Jashore, Bangladesh.



7408
Other 
Phone  8801735661492  
Fax    
Email  amranphysio@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Dr. M R Khan medical center, Jashore University of Science and Technology, Jashore, Bangladesh. 
 
Primary Sponsor  
Name  Ahamadullah Hil Galeb 
Address  Room no 304, Department of Physiotherapy and Rehabilitation, Dr. M R Khan medical center, Jashore University of Science and Technology, Jashore, Bangladesh. 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  N/A 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Professor Dr Iqbal Kabir Jahid   Dr. M R Khan Medical centre  Room no 304, Department of Physiotherapy and Rehabilitation, Dr. M R Khan medical center, Jashore University of Science and Technology, Jashore, Bangladesh.

 		 8801709818178

ikjahid_mb@just.edu.bd 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Dr. M R Khan Medical Center  No Objection Certificate 
Jashore University of Science and Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  N/A  N/A 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1) Participants with anxiety, Depression, and Stress according to DASS-21, 2) Participants having suicidal ideation according to Beck suicidal ideation Scale  
 
ExclusionCriteria 
Details  1) Unwilling students, 2) Incomplete response  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Depression, Anxiety, Stress   3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Suicidal Ideation   3 months  
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="0" 
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)   00/00/0000 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/08/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mailtogaleb@gmail.com].

  6. For how long will this data be available start date provided 07-11-2023 and end date provided 07-06-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The objective of the study is to elicit the behavioral predictors of anxiety, depression, stress, and  suicidal ideation for the University student of Jashore University of Science and Technology, Bangladesh  
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