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CTRI Number  CTRI/2024/07/070702 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Developing of a task for visual reasoning abilities for patients with alcohol problems  
Scientific Title of Study   Construction and validation of a tool for measuring visual abstract reasoning in patients with alcohol dependence (VisAR-AD) 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sai Chandana Mukkamala  
Designation  M.Phil Trainee  
Affiliation  Manipal college of health professions  
Address  Department of clinical psychology, Manipal College of Health Professions, MAHE, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9108817879  
Fax    
Email  chandana.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Ms Anagha Deshmukh 
Designation  Guide 
Affiliation  Manipal college of health professions  
Address  Department of clinical psychology, Manipal College of Health Professions, MAHE, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7259619947  
Fax    
Email  anagha.deshmukh@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Anupama Vigneshwaran  
Designation  Assistant Professor  
Affiliation  Manipal college of health professions  
Address  Department of clinical psychology, Manipal College of Health Professions, MAHE, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9739016983  
Fax    
Email  v.anupama@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, MAHE, Manipal, Udupi KARNATAKA 576104  
 
Primary Sponsor  
Name  Sai Chandana Mukkamala 
Address  Department of clinical psychology, Manipal college of health professions, Manipal academy of higher education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka  
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 
Sai Chandana Mukkamala  Kasturba Hospital  Department of Psychiatry, 3rd Floor, Old OPD Block, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9108817879

chandana.mchpmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics 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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Cases
1. Diagnosed with the ICD 11 (DCR) criteria for Alcohol dependence
2. Males between the age group 18- 50.
3. Ability to speak and understand either English or Kannada languages.
4. A score of lesser than 10 on Clinical Institute Withdrawal Scale (CIWA).

Healthy Controls

1. Males between the age group of 18-50.
2. Ability to speak and understand either English or Kannada languages.
3. Individuals scoring below 2 on the GHQ-5. 
 
ExclusionCriteria 
Details  Cases
1. Any other Axis 1 psychiatric diagnoses except nicotine dependence.
2. Any personal history of neurological, major medical illness and psychiatric illness(Schizophrenia, Mood disorder, Anxiety disorder and OCD).

Healthy Controls

1. Any personal history of neurological, major medical illness and psychiatric illness (Schizophrenia, Substance use disorder, Mood disorder, Anxiety disorder and OCD). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Score on visual abstract reasoning task
Score on verbal abstarct reasoning task 
Baseline & 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   01/08/2024 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The review of literature highlights the impact of alcohol misuse on cognitive functions, particularly abstract reasoning, emphasizing the need for specialized assessments tailored to individuals with alcohol dependence. Existing neuropsychological evaluations often lack sensitivity in this population, underscoring the necessity of developing dedicated tools. Studies indicate significant differences in abstract reasoning abilities between alcohol-dependent individuals and healthy controls, reinforcing the importance of accurate assessment methods tailored to the target population.

The study aims to develop and validate a tool for assessing visual abstract reasoning among patients diagnosed with alcohol dependence in India, addressing the lack of culturally relevant assessment tools for this population. This tool’s construction and validation involve several steps, including the selection of culturally appropriate stimuli and validation among patients with alcohol dependence. The absence of such a tool hampers the precise evaluation of cognitive and psychological impairments linked to alcohol use and impedes the formulation of personalized treatment strategies. 

Inclusion criteria for cases require a diagnosis of alcohol dependence according to ICD 11 criteria, while healthy controls must fall within specific age ranges and exhibit no signs of psychiatric illness. Exclusion criteria aim to eliminate factors such as other psychiatric diagnoses or major medical illnesses. The statistical methods employed include descriptive analysis, item analysis, and validation techniques to establish the tool’s reliability and validity. Tools utilized in the study encompass various assessments, including the General Health Questionnaire-5, Clinical Institute Withdrawal Scale, Severity of Alcohol Dependence Questionnaire, Verbal Similarities Test of Abstract Reasoning, and Digit Repetition Test.

The detailed procedure involves multiple phases, including item construction, expert validation, and pilot testing, culminating in the validation phase with data collection from cases and controls. Potential risks are minimal, mainly involving discomfort in answering sensitive questions, while benefits include the construction of a novel tool with implications for interventions. Ethical considerations prioritize informed consent, participant rights, confidentiality, and anonymity.


 
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