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CTRI Number  CTRI/2023/11/060170 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 22/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Deficits in cognition in individuals having alcohol abuse with and without having experienced adverse childhood events. 
Scientific Title of Study   Cognitive Deficits in Alcohol Dependence Syndrome (ADS) Patients with and without Adverse Childhood Experiences (ACE). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mota Prachi Himansu Anila 
Designation  M.Phil Trainee 
Affiliation  MCHP 
Address  Dept. of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi- 576104

Udupi
KARNATAKA
576104
India 
Phone  9930939156  
Fax    
Email  mota.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Anagha Deshmukh 
Designation  Assistant Professor (Senior Scale) 
Affiliation  MCHP, MAHE 
Address  Dept. of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi- 576104

Udupi
KARNATAKA
576104
India 
Phone  7259619947  
Fax    
Email  anagha.deshmukh@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Diti Kohli 
Designation  Assistant Professor 
Affiliation  MCHP, MAHE 
Address  Dept. of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi- 576104

Udupi
KARNATAKA
576104
India 
Phone  8447326877  
Fax    
Email  kohli.diti@manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi- 576104, Karnataka, India. 
 
Primary Sponsor  
Name  Mota Prachi Himansu Anila 
Address  Dept of Clinical Psychology, MCHP,MAHE, Manipal, Udupi- 576104, Karnataka, India. 
Type of Sponsor  Other [Prinicipal/Primary Investigator] 
 
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 
Mota Prachi Himansu Anila  Kasturba Hospital  Room no. 33, Department of Psychiatry, Old OPD building, 3rd Floor, Kasturba Hospital, Manipal, Udupi- 576104, Karnataka.
Udupi
KARNATAKA 		 9930939156

mota.mchpmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F102||Alcohol dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Group 1 (ADS + ACE)
1. Individuals diagnosed with ADS
2. ADS for minimum 5 years based on ICD-11 Criteria (abstinent for at least 1 week- CIWA score less than 9)
3. Individuals with a frequency score of at least 1 on ACE-IQ
4. Males aged 18- 50 years
5. Abstinence of less than 1 year
6. At least 5 years of formal education (5th standard reading level) and ability to read, write and speak in English or Kannada

Group 2 (ACE)
1. Individuals without ADS.
2. Individuals with a frequency score of at least 1on the ACE-IQ
3. Matched group (based of age and education) of males aged 18- 50 years
4. At least 5 years of formal education (5th standard reading level) and ability to read, write and speak in English or Kannada

Group 3 (ADS)
1. Individuals diagnosed with ADS
2. ADS for minimum 5 years based on ICD-11 Criteria (abstinent for at least 1 week- CIWA score less than 9)
3. Individuals with a frequency score of 0 on ACE-IQ.
4. Matched group (based of age and education) of males aged 18- 50 years
5. Abstinence of less than 1 year
6. At least 5 years of formal education (5th standard reading level) and ability to read, write and speak in English or Kannada
 
 
ExclusionCriteria 
Details  Group 1 (ADS + ACE)
1. Other substance disorders (except nicotine)
2. Major psychiatric disorders (moderate to severe mood disorders, psychotic disorders, and anxiety disorders)
3. Individuals with severe cognitive deficits, for instance, individuals with Korsakoff’s syndrome, which may hinder the quality and accuracy of data collection.
4. Individuals with major neurological conditions including traumatic brain injury, road traffic accidents, epilepsy.
5. Other major medical comorbidities which may affect cognitive functioning.

Group 2 (ACE)
1. Any Disorders due to Substance Use
2. Other major psychiatric disorders (moderate to severe mood disorders, psychotic disorders, and anxiety disorders)
3. Individuals with severe cognitive deficits, for instance, individuals with dementia, which may hinder the quality and accuracy of data collection.
4. Individuals with major neurological conditions including traumatic brain injury, road traffic accidents, epilepsy.
5. Other major medical comorbidities which may affect cognitive functioning.

Group 3 (ADS)
1. Individuals with a frequency score of 1 or more on ACE-IQ.
2. Other substance disorders (except nicotine)
3. Major psychiatric disorders (moderate to severe mood disorders, psychotic disorders, and anxiety disorders)
4. Individuals with severe cognitive deficits, for instance, individuals with Korsakoff’s syndrome, which may hinder the quality and accuracy of data collection.
5. Individuals with major neurological conditions including traumatic brain injury, road traffic accidents, epilepsy.
6. Other major medical comorbidities which may affect cognitive functioning.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Cognitive Control
a. Working Memory: Score on Verbal N2-Back Test (hits, omission, commission, error), Digit Span (forward, backward, total) and Spatial Span (forward, backward, total)
b. Behavior-Inhibition & Distractor Interference Control: Go/No Go Task (mean accuracy, mean error, response time)

2.Visual Learning & Memory: Scores on Family Pictures Test (Recall 1 & 2, Percent Retention)

3.Verbal Learning & Memory: Scores on Rey’s AVLT (immediate & delayed recall, recognition).

 		 Baseline

 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   30/11/2023 
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="9"
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  

There is a vast literature on the cognitive deficits incurred due alcohol dependence syndrome and alcohol use disorder (Madhusudhan, Anitha & Ruth, 2021; Smith, Mattick, Jamadar & Iredale, 2014). Several studies have also explored the cognitive deficits in individuals with ACE (O’Shea, Demakakos, Cadar, & Kobayashi, 2021; Hawkins et al., 2021). Studies have also shown the association between ADS and ACEs (Leza, Siria, López-Goñi, & Fernández-Montalvo, 2021; Loudermilk, Loudermilk, Obenauer, & Quinn, 2018; Fuller-Thomson, Roane & Brennenstuhl, 2016). However, studies have not compared the differences in cognitive functioning (memory and cognitive control) in individuals having ADS with and without ACEs. Extremely few studies have explored the relationship between ACE and cognitive control (Kalia, Knauft, & Hayatbini, 2021). Several studies have been conducted on college students and early adults with excessive alcohol use, not specifically catering to the patient population, especially in the Indian setting. The WHO developed the Adverse Childhood Experiences International Questionnaire (ACE-IQ) to be inclusive of a more holistic view on hardship (WHO, 2011a, 2011b, 2011c). As of yet very few studies have been issued utilizing this instrument. Several researches have shown that adverse childhood events lead to cognitive deficits and even alcohol dependence leads to cognitive deficits. Literature has described cognitive deficits associated with ADS and it also elaborates on the cognitive deficits associated with ACE. However, literature does not focus on individuals who have both ADS and ACE and the cognitive deficits associated with them. Research has also shown a strong link between ADS and ACE (Leza, Siria, López-Goñi, & Fernández-Montalvo, 2021), there is a shortage of adequate empirical researches on the mechanisms that underlie this link (Türkmen, Machunze, Tan, Gerhardt, Kiefer, & Vollstädt-Klein, 2022). Literature has not been able to isolate the differences in cognitive deficits among individuals with ACE, ADS and ADS with ACE and understand the underlying mechanisms between ACE, ADS and cognitive deficits. 

The present study aims to understand the differences in deficits in memory and cognitive control in individuals with ADS (without ACE), ACE (without ADS), and ADS with ACE. The study hypothesises that cognitive deficits are more in individuals with ACE +ADS as compared to only ADS (without ACE). Cognitive deficits are more in individuals with only ADS (without ACE) as compared to those with only ACE (without ADS).


 
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