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Clinical Trials/CTRI/2023/11/060170
CTRI/2023/11/060170
Not yet recruiting
Not Applicable

Cognitive Deficits in Alcohol Dependence Syndrome (ADS) Patients with and without Adverse Childhood Experiences (ACE).

Mota Prachi Himansu Anila1 site in 1 country126 target enrollmentStarted: November 30, 2023Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Mota Prachi Himansu Anila
Enrollment
126
Locations
1
Primary Endpoint
1. Cognitive Control

Overview

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).

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • Group 1 (ADS + ACE)
  • Individuals diagnosed with ADS
  • ADS for minimum 5 years based on ICD-11 Criteria (abstinent for at least 1 week- CIWA score less than 9)
  • Individuals with a frequency score of at least 1 on ACE-IQ
  • Males aged 18- 50 years
  • 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)
  • Individuals without ADS.
  • Individuals with a frequency score of at least 1on the ACE-IQ
  • Matched group (based of age and education) of males aged 18- 50 years
  • Individuals with a frequency score of 0 on ACE-IQ.

Exclusion Criteria

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

Outcomes

Primary Outcomes

1. Cognitive Control

Time Frame: Baseline

a. Working Memory: Score on Verbal N2-Back Test (hits, omission, commission, error), Digit Span (forward, backward, total) and Spatial Span (forward, backward, total)

Time Frame: Baseline

b. Behavior-Inhibition & Distractor Interference Control: Go/No Go Task (mean accuracy, mean error, response time)

Time Frame: Baseline

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

Time Frame: Baseline

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

Time Frame: Baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mota Prachi Himansu Anila
Sponsor Class
Other [Prinicipal/Primary Investigator]
Responsible Party
Principal Investigator
Principal Investigator

Mota Prachi Himansu Anila

MCHP

Study Sites (1)

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