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CTRI Number  CTRI/2025/03/081747 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of cognitive control training in improving mental function among patients with major depression. 
Scientific Title of Study   Efficacy of cognitive control training on alleviating cognitive deficits in individuals with MDD 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwini Rajmohan 
Designation  Ph.D Scholar 
Affiliation  Kalinga Institute of Medical Sciences 
Address  OPD No.1, Department Of Psychiatry,Kalinga Institute Of Medical Sciences, Bhubaneswar, Odisha.

Khordha
ORISSA
751024
India 
Phone  8328982245  
Fax    
Email  ashwininair316@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sayali Mishra  
Designation  Assistant Professor  
Affiliation  Kalinga Institute of Medical Sciences 
Address  Room no.1, Dept. of Psychiatry,Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha

Khordha
ORISSA
751024
India 
Phone  7873383039  
Fax    
Email  sayali.mishra@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Ashwini Rajmohan 
Designation  Ph.D Scholar 
Affiliation  Kalinga Institute of Medical Sciences 
Address  OPD No.1, Department of Psychiatry,Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha


ORISSA
751024
India 
Phone  8328982245  
Fax    
Email  ashwininair316@gmail.com  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences Kushabhadra Campus 5, KIIT Rd, Bhubaneswar, Odisha-751024 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 RAMA CHANDRA DAS  KALINGA INSTITUTE OF MEDICAL SCIENCES  Room no. 1, Department of Psychiatry, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha
Khordha
ORISSA 		 8411044558

ramachandra.das@kims.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, KIMS  Approved 
Institutional Ethics Committee, KIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive Control Training  The Cognitive Control Training (CCT) intervention will be conducted over a period of 8 weeks, consisting of 16 structured sessions, with a frequency of two sessions per week. Each session will last approximately 45 to 60 minutes and will be delivered in an in-person, hospital-based setting at KIMS, Bhubaneswar. The training program is designed to improve cognitive control abilities, specifically targeting attention, working memory, and response inhibition. 
Comparator Agent  Waitlist Usual Care  The comparator group will be a Waitlist Usual Care group, where participants will receive standard pharmacological treatment, including medication as prescribed by psychiatrists, along with supportive therapy as part of routine psychiatric care. Unlike the intervention group, these participants will not receive any active cognitive training intervention during the study period. However, they will undergo the same assessment schedule as the CCT group, with cognitive and clinical evaluations conducted at baseline, post-intervention (4 weeks post), and follow-up (8 weeks post). This study design ensures a rigorous comparison between the intervention and control groups, providing valuable insights into the efficacy of CCT in alleviating cognitive deficits associated with Major Depressive Disorder (MDD). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A diagnosis of depression according to ICD-11 criteria.
Patients with MADRS score ranging between 7 and 34 will be included.
Patients who can speak English, Hindi and Odia.
Patients should have completed formal education up to at least the 10th-grade level.
Patients from ages 18-60 years will be included in the study.
 
 
ExclusionCriteria 
Details  Patients with severe suicidal ideations will be excluded.
Patients who have missed scheduled appointments for the therapy sessions.
The presence of co-morbid mental health disorders (Bipolar disorders, Schizophrenia, substance use, personality disorder) will be excluded to maintain homogeneity in the study sample.
Organic mental disorders
Patients who are receiving antipsychotics, sedatives, and benzodiazepines will be excluded
Unwillingness or inability to provide informed consent.
Excluding major physical and surgical neurological conditions.
Anyone with structured therapy will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The study aims to assess the efficacy of Cognitive Control Training (CCT) on working memory and its impact on performance in the Wisconsin Card Sorting Test (WCST) and Stroop Test over an 8-week period.  8WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
The study aims to assess the efficacy of Cognitive Control Training (CCT) on attention & its impact on performance in the Wisconsin Card Sorting Test (WCST) & Stroop Test over an 8 week period. It also aims to evaluate the efficacy of CCT on response inhibition & its effect on WCST & Stroop Test scores over the same duration. Additionally, the study will assess changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores in relation to improvements in cognitive deficits.  8 WEEKS 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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    
Date of First Enrollment (India)   17/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/03/2025 
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)  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   The study titled "Efficacy of cognitive control training(CCT) on alleviating cognitive deficits in individual with major depressive disorder(MDD)" explores the impact of CCT on cognitive impairments commonly associated with MDD, such as deficits in attention, working memory and executive functioning (Rock et al., 2014; Snyder,2013). Traditional technique including pharmacotherapy and psychotherapy, primarily target mood symptoms but often fail to address persistent cognitive impairments (Bowie et al.,2013; shiels et al., 2021). This randomized controlled trial (RCT) aims to evaluate the efficacy of 8 week CCT program, consisting of 16 in session training sessions designed to improve cognitive control abilities (Keshavan et al., 2014; Siegle et al., 2014). The study employs standardized cognitive assessments, including the Wisconsin Card Sorting Test (WCST) and the Stroop Test, along with the Montgomery-Asberg Depression Rating Scale (MADRS) to measure cognitive and depressive symptom changes over time. Participants will be assessed at baseline, four weeks post-intervention, and eight weeks after the intervention’s completion to determine the durability of the training effects. Statistical analyses will compare cognitive performance between the intervention and control groups, offering valuable insights into whether CCT can serve as an adjunctive treatment for MDD-related cognitive deficits. If proven effective, CCT could be integrated into clinical practice to enhance cognitive function, improve overall treatment outcomes, and inform future mental health interventions (McIntyre et al., 2013; Rane et al., 2018). 
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