| 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
|
|
|
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
|
|
|
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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