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CTRI Number  CTRI/2023/09/057529 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 05/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Intervention for Cognitive Difficulties in Depression 
Scientific Title of Study   Adaptation and Feasibility of a Brief, Integrated Cognitive Control Training Intervention for Depression 
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti Kodancha 
Designation  Trainee 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  08310508371  
Fax    
Email  preetikodancha.psych@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Himani Kashyap 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  7760230223  
Fax    
Email  drhimanikashyap@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Preeti Kodancha 
Designation  Trainee 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  08310508371  
Fax    
Email  preetikodancha.psych@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 
 
Primary Sponsor  
Name  Preeti Kodancha 
Address  3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore 
Type of Sponsor  Other [Self] 
 
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 
Preeti Kodancha  National Institute of Mental Health and Neuro Sciences  3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore
Bangalore
KARNATAKA 
8310508371

preetikodancha.psych@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee (Behavioural Sciences Division)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F328||Other depressive episodes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated Cognitive Control Training Intervention  The ICCT is a cognitive training intervention that was originally developed for OCD (Kashyap et al., 2019). The targets of the intervention included cognitive control and goal-directed flexible adjustments of behaviour. The intervention was based on Bowie et al.’s (2015) ‘Three Pillars of Cognitive Training’ described above. The intervention consists of components of cognitive stimulation, metacognitive strategy monitoring, and generalization. The intervention was first conducted as a 12-week program with therapist-guided sessions once a week and additional homework sessions over two months. A case report of this intervention on a 29-year-old revealed improvements in various aspects of executive functioning (predominantly in verbal fluency and planning), along with improvement in depressive and anxiety-related symptoms. Importantly, the intervention led to improvement in subjectively perceived cognitive difficulties, and improved functionality across occupational and interpersonal (Kashyap et al., 2019). The intervention was also adapted as an eight-week, 24 hours program for patients with remitted OCD (Rini et al., 2019) – a preliminary study showed that the intervention group demonstrated significant improvements compared to the control group with moderate to large effect sizes. Most importantly, these results were found to generalize to other untrained cognitive, clinical and socio-occupational domains – hence, unlike existing interventions, the ICCT was able to demonstrate a broad transfer of effects. This eight-week program for patients with OCD (Bhattacharya, Kashyap, & Reddy, 2022) was later also found to bring about significant improvements in cognitive and executive deficits in a sample of 38 OCD patients, and the improvement was noted in different domains of everyday functioning, which was maintained at three-months follow-up, once again demonstrating a broad transfer of effects and treatment generalization to everyday functionality. 
Comparator Agent  NOT APPLICABLE - SINGLE ARM STUDY  NOT APPLICABLE - SINGLE ARM STUDY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. The individual must be between the ages of 18 years to 50 years.
2. The individual must have a minimum of 7th grade education.
3. The individual must be fluent in English, or Kannada.
4. The individual must be diagnosed as having a depressive episode, of mild/moderate/severe types as per the ICD-11 Diagnostic Criteria for Research.  
 
ExclusionCriteria 
Details  1. The individual must not have psychotic or catatonic symptoms as a part of the depressive syndrome.
2. The individual must not be at serious risk of harm to self.
3. The individual must not have intellectual disability based on clinical observations.
4. The individual must not have any form of substance dependence (other than nicotine)
5. The individual must not have a history of neurological conditions such as tumours, epilepsy, stroke, traumatic brain injury, and degenerative disorders, or other severe psychiatric illness including Bipolar Affective Disorder and Psychotic illnesses.
6. The individual must not have any sensorimotor impairments on clinical examination or self-report, which may interfere with assessments/training.
7. The individual must not have undergone any structured psychological intervention of more than 3 sessions in the past 3 months.
8. The individual must not have received any form of brain stimulation in the past 3 months.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perceived Deficits Questionnaire, Colour Trails Test - 2  Before Intervention, Within one week of intervention completion 
 
Secondary Outcome  
Outcome  TimePoints 
Metacognitive Awareness & Regulation Scale, Colour Trail Test – 1, Digit Span, Spatial Span, Controlled Oral Word Association Test, Hopkins Verbal Learning Test – Revised, Block Design Test, Stop Signal Task  Before Intervention, Within one week of intervention completion 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   02/10/2023 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

  Depression is a common mental disorder as per the World Health Organization (WHO). As per WHO estimates, about 5% of the adult population in the world suffers from depression, amounting to 280 to 300 million sufferers worldwide (WHO, 2021). Depression is characterized by the presence of the hallmark features of low mood, decreased interest in previously pleasurable activities, and easy fatiguability, and is often accompanied by other symptoms like persistent feelings of guilt, decreased self-esteem, decreased concentration and attention, ideas of self-harm and suicide, decreased appetite, and decreased sleep. One factor that is associated to the impairment in Quality of Life in individuals with depression is the cognitive deficits accompanying the diagnosis. Cognitive deficits are a well-documented and researched symptom cluster associated with depressive disorders.

While cognitive symptoms of depression are particularly debilitating, persist beyond affective symptom remission, and increase risk of relapse, they are not targeted or resolved by evidence-based pharmacotherapeutic and psychotherapeutic treatment. Existing cognitive training interventions which target the cognitive symptoms.

  • Are time and labour-intensive, posing significant challenges in the acceptability and feasibility of the interventions.
  • Do not focus on the broad generalization of the treatment gains to everyday functioning.
  • Do not emphasize the subjective perception of cognitive deficits, and their contribution to disruption in socio-occupational functioning.

In light of the above-highlighted gaps in the literature, the Integrated Cognitive Control Training (ICCT) intervention, a cognitive training intervention with components of cognitive stimulation, metacognitive strategy training, and generalization, originally developed for OCD, offers viable promise for addressing all the lacunae in existing interventions highlighted above.

  • First, this intervention has previously been adapted to be brief (originally developed as a 12-week intervention, and later adapted to an eight-week format) and shown to be effective in the abbreviated format. 
  • Further, the intervention’s focus on building metacognitive skills is a means to directly target the subjective perception of cognitive deficits noted in depression.
  • The intervention also places specific emphasis on the generalization of treatment gains, with one component of the intervention exclusively dedicated to the same – current evidence does show that the intervention does positively impact everyday functioning. 
  • Finally, existing literature shows that the ICCT leads to a decrease in depressive symptoms in OCD – this can be taken as the basis to hypothesize that the intervention can be adapted to an intervention exclusive to the depressive symptoms; while the core components of the interventions can be retained, the intervention itself can be abbreviated to cater to the milder cognitive deficits in depression as compared to OCD.

The current study is an attempt to adapt the ICCT as a brief intervention to address objectively assessed and subjectively perceived cognitive deficits in depression and to test the feasibility of such an intervention in the depressive population.

 
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