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CTRI Number  CTRI/2025/04/084522 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 13/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Attention Training Technique on self-regulation for patients with Depressive Disorders 
Scientific Title of Study   Efficacy of Wells Attention Training Technique on components of self-regulation among patients 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  Shivanee Tripathy 
Designation  PhD Scholar and Consultant 
Affiliation  Kalinga Institute of Medical Sciences, KIIT University 
Address  N-1/294 IRC VILLAGE NAYAPALLI, BHUBANESWAR

Khordha
ORISSA
751015
India 
Phone  9654153411  
Fax    
Email  2281224@kims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Shivanee Tripathy 
Designation  PhD Scholar and Consultant 
Affiliation  Kalinga Institute of Medical Sciences, KIIT University 
Address  N-1/294 IRC VILLAGE NAYAPALLI, BHUBANESWAR

Khordha
ORISSA
751015
India 
Phone  9654153411  
Fax    
Email  2281224@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Shivanee Tripathy 
Designation  PhD Scholar and Consultant 
Affiliation  Kalinga Institute of Medical Sciences, KIIT University 
Address  N-1/294 IRC VILLAGE NAYAPALLI, BHUBANESWAR

Khordha
ORISSA
751015
India 
Phone  9654153411  
Fax    
Email  2281224@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, Kusabhadra Campus, KIMS Rd, Chandaka Industrial Estate, K I I T University, Patia, Bhubaneswar, Odisha 751024, India 
 
Primary Sponsor  
Name  Shivanee Tripathy 
Address  N-1/294 IRC Village Nayapalli Bhubaneswar-751015 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sayali Mishra  InPatient Ward , Department of Psychiatry, Kalinga Institute of Medical Sciences   Kusabhadra Campus, KIMS Rd, Chandaka Industrial Estate, K I I T University, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA 		 7873383039

sayali.mishra@kims.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cognitive Behaviour Therapy or Supportive Psychotherapy along with Pharmacotherapy  Patients in this group will be given the treatment as usual for Moderate Depressive Disorders An informed consent will be taken from the participants fulfilling the inclusion criteria for the study. Tools chosen for the study will be both used to assess variables Pre and Post intervention. The intervention selected for control group will be administered for two weeks. Observation points of the study will be baseline (pre-intervention), post two weeks (immediate effect) and after one month (long sustained effect). 
Intervention  Wells Attention Training Technique  An informed consent will be taken from the participants fulfilling the inclusion criteria for the study. Tools chosen for the study will be both used to assess variables Pre and Post intervention. The intervention of ATT will be administered on patients twice a day for two weeks. Observation points of the study will be baseline (pre-intervention), post two weeks (immediate effect) and after one month (long sustained effect). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. A diagnosis of Mild to Moderate Depression according to ICD 10
2. Educational qualification of patient to be minimum completion of Class 10
3. Patients giving consent 
 
ExclusionCriteria 
Details  1. Patients with severe psychomotor agitation
2. Patients diagnosed with organic medical conditions
3. Patients with substance dependence, suicidality, severe depression and catatonia
4. Patients with organic brain disorders
5. Patients who are pregnant
6. Patients with physical, surgical or neurological conditions
7. Patients prescribed with sedatives(Benzodiazepine or anti-psychotic drugs) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of attention training technique on set shifting in Depression  Pre Intervention
Post Intervention; Immediate Effect (post 2 weeks)
Post Intervention; Sustained effect (post 1 month)  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of attention training technique on components of self-regulation
like interoceptive awareness, attentional control, worry and meta-cognition in
depressive patients through pre- and post-assessments.
To explore whether changes in scores of self regulation measures, effect on changes in scores of Depression 		 After two weeks for Immediate effect
After one month for sustained effect 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   19/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   We are aiming for studying the effects of Wells Attention Training Technique on components of self regulation in patients with Moderate Depressive Disorder. There would be a pre assessment for the purpose of screening patients as per the inclusion criteria as well as for understanding the components of self regulation through some tools.The post assessment would be conducted at two time points, that is, after 2 weeks to measure and assess the immediate effect and after 1 month of the intervention to assess the sustained effect. 
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