Brief Proposal

1. Title of the project: Cross Cultural Indian Adaptation, Validation, and Standardization of the Brief Executive Function Assessment Tool for Patients with Alcohol Dependence

2. Type of Study: Prospective study- cross sectional study

3. Aims & objectives (hypotheses if applicable):

Aim: Adaptation, validation, and standardization of a Brief Executive Function Assessment Tool for patients with alcohol dependence (BEAT – AD) in the Indian context.

Objectives:

•         To culturally adapt and validate the Brief Executive Function Assessment Tool (BEAT – AD) for patients with alcohol dependence.

•         To develop norms for the Brief Executive Function Assessment Tool (BEAT – AD) for patients with alcohol dependence in the Indian context.

4. Study period: July 2024 to October 2028

5. Sample size: A total of 280 patients with alcohol dependence and 190 healthy controls would be recruited throughout the study from the hospital premises.

6. Sampling method: convenience sampling for healthy controls and purposive sampling for patients with alcohol dependence will be used.

Inclusion criteria for healthy controls

1.      Males aged between 18-50 years.

2.      Ability to speak and understand English or Kannada.

3.      General Health Questionnaire – 5 score <1.

Exclusion criteria for healthy controls

1.      Any personal history of major neurological, medical (DM, chronic liver disease), psychiatric disorders) (Mood, OCD, Psychosis), neurological disorders or substance abuse (AUDIT score more than 8).

2.      Personal history of epilepsy, significant head injury or any neurosurgical procedure.

3.      Any family history of substance use disorders or major psychiatric illness (Mood, OCD, Psychosis) in first degree relatives.

Inclusion criteria for patients with alcohol dependence

1.      Patients diagnosed with Alcohol Dependence according to ICD-11 Diagnostic Criteria for Research (WHO 2022).

2.      Male patients aged between 18 – 50 years.

3.      Patients not in active withdrawal as defined by CIWA-Ar score less than 10.

4.      Ability to read and speak Kannada or English.

Exclusion criteria for patients with alcohol dependence

1.      Patients fulfilling ICD-11 Diagnostic Criteria for Research (WHO 2022) for other substance dependence syndrome, except nicotine.

2.      History of comorbid other major psychiatric disorder(s) (Mood, OCD, Psychosis), or neurological disorders affecting cognitive abilities or major medical disorder(s) (uncontrolled DM, chronic liver disease, chronic renal disease).

3.      History of epilepsy, significant head injury or any neurosurgical procedure.

7. Tools used:

1. Sociodemographic sheet (healthy controls): this will include questions pertaining to age, education, occupation, family, and personal psychiatric and medical history.

2. Sociodemographic and clinical data sheet (patients with alcohol dependence): this will include questions pertaining to age, education, occupation, family history of substance use or major psychiatric illness, age of first consumption of substance, age of regular drinking, age of dependence, pattern of dependence, no of abstinent episodes, maximum duration of abstinence, total duration of abstinence and duration since the last drink.

3. General Health Questionnaire – 5 (Shamasundar, Sriram, Murali Raj & Shanmugham, 1986) (GHQ – 5): The tool will be used for identifying minor psychiatric disorders in healthy participants. This scale will be used to screen the healthy controls prior to recruitment for the study. It has a total of 5 items. 1 point is assigned for each question if answered as “yes” by the participant. A cut of score of 2 is used to identify people having mental health concerns. For the healthy participants getting a score of 2 or greater will be excluded and referred to an appropriate health care professional as required. The test is simple to understand and easy to administer. It takes approximately 3 – 4 minutes to complete.

4. Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, & Sellers, 1989): It is the most widely used tool to assess the severity of alcohol withdrawal. It is clinically useful and takes around 5 minutes to administer. It comprises of 10 items each scored on a 7-point Likert scale, except for one item pertaining to orientation and clouding of sensorium which needs to be scored on a 4-point Likert scale. The maximum score possible on the scale is 67. A cut off point of 15 or below is an indication of mild alcohol withdrawal while 16 to 20 indicates moderate withdrawal. A score of 20 or greater suggests severe withdrawal. The scale will be used to exclude patients with withdrawal symptoms. Patients with a score of more than 10 on CIWA-Ar will be excluded from the study. Reliability of this scale is high (r > 0.80) (Sullivan, 1989).

5. The Alcohol Use Disorders Identification Test: Interview Version (AUDIT) (WHO, 1989): The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. A score of 8 or more is considered to indicate hazardous or harmful alcohol use. It is a widely used tool both globally and nationally and has well established psychometric properties.

6. DIAMOND psychiatric interview (screening form) (Version 1.5) (Tolin et al., 2016): It is a structured clinical interview for screening anxiety disorders, bipolar disorders, depressive disorders, obsessive-compulsive and related disorders, trauma- and stress related disorders, schizophrenia spectrum and other psychotic disorders, feeding and eating disorders, somatic symptom and related disorders, substance-related and addictive disorders, and neurodevelopmental disorders. Based on the self-report form an interview will be conducted for only the items marked as “Yes”. During the interview if all criteria are rated "yes," the diagnosis should be considered present. The interview requires 30 minutes to complete.

7. Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005): This brief 12 item scale that assesses various higher order cognitive and executive functions will be administered only to the patients with alcohol dependence. Higher scores are indicative for intact cognitive functioning. The scores range from 0 – 30 with a score below 26 (cut-off) indicating cognitive impairment. The outcome measure would be the MoCA total score. To correct for the effects of education, 1 additional point is awarded to individuals whose education is below 12 years. It takes 10 – 12 minutes to administer and has high test-retest reliability (0.92) and internal consistency (0.83). Standardized translations of the MoCA are available in the Kannada language and will be used in the study along with the English versions.

8. ACE Screening tool (Berry et al 2020): It is a 12-item screening tool of risk factors for cognitive impairment. It is scored in a forced choice format with Yes or No response. The questions are asked to the patients and their responses are recorded. The total score is calculated by summing Yes responses across the 12 items. It has strong positive correlations with the BEAT and is used as part of a two-stage screening process in patients with substance use prior to administration of the BEAT. The selected questions also demonstrate good reliability and validity.

9. Semi-structured interviews: the participants will be asked 5 questions pertaining to their experiences related to the test and the testing process. They will first rate them on a 5-point Likert scale (0 – very bad; 1 – bad; 2 – neutral, 3 – good, and 4 – very good) and then provide an explanation for the same.

The questions would include:

a)      How was your overall experience of the test?

b)      Were the instructions easy to understand and remember for each task?

c)      Were the stimuli used in the test easily recognizable?

d)      Is there something would like to change about the test?

e)      Which was your most and least favourite test?

The Index test: Brief Executive Functions Assessment Tool Indian (BEAT) (Berry et al., 2022): It is a tool used to detect cognitive impairment, and particularly executive function impairment, in a substance use disorder population. It is intended for use in conjunction with the alcohol and drug cognitive enhancement (ACE) screening tool to identify individuals who may need support to obtain the greatest benefit from substance use disorder treatment. The BEAT will provide a score that grossly indicates whether a person has intact or impaired cognitive functioning. It consists of a total of 20 sub-tests that assess various executive function domains.

The test has three parts:

a) Record form. This is for the examiner to record examinee responses.

b) Response form. This is for the examinee to complete the trail making, clock drawing and figure copying activities. It also contains the questionnaire, which may either be read by the examiner, or given to the examinee to complete.

c) Stimulus card. This contains the stimuli for the reading and naming activities. It is recommended that examiners laminate a re-usable version of the stimulus card, rather than print one off for each examination.

The original version of the tool has been shown to demonstrate known-groups validity, criterion validity, good classification statistics, internal consistency, test-retest reliability, inter-rater reliability, and construct validity. Furthermore, used in combination with the ACE Screening Tool, it demonstrates incremental validity, with the two-step screening process showing excellent classification statistics (99% sensitivity to cognitive impairment).

8. Procedure:

•         All approvals and clearances will be taken.

•         Pilot round 1 – 10 patients with alcohol dependence will be used to test the feasibility and applicability of the adapted and translated tool.

•         Pilot round 2 – 20 patients and 40 healthy controls will be recruited for establishment of preliminary validity and reliability indices.

•         Final phase – standardization and norms will be developed for patients with alcohol dependence. 250 patients and 150 healthy controls will be recruited in this phase.

•         The cognitive tests and screening questionnaires will be administered in individual format in each phase. Each complete administration would require 35-40 minutes.

•         All ethical concerns and confidentiality guidelines will be followed.

•         All publications will be made with due citations and acknowledgements.