Development of objective indicators to predict the effects of brief interventions in habitual drinkers

JRCT ID: jRCT1030240144

Registered date:07/06/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: alcohol use diosrder
• Date of first enrollment: 08/03/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): The study will provide approximately 30 minutes of advice and counseling on drinking behavior (brief intervention). The brief intervention was based on what has been shown to be effective in previous research. During the intervention, participants were asked to complete six tasks on a worksheet. The worksheet included cognitive-behavioral therapy, explanation of the AUDIT and feedback of results, advantages and disadvantages of drinking, goal setting for drinking behavior, and how to deal with situations that might lead to heavy drinking.

Outcome(s)

• Primary Outcome: P300 amplitude during oddball task

Secondary Outcome

TMT score
stroop test score
DSST score
verbal fluency score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1) Drinks alcohol on three or more days per week,
2) Drinking more than the following amounts
Men: 4 or more drinks (2 x 500 ml beer, 2 x 1 g of sake, 2 x 350 ml canned shochu, 1 g of shochu, 4 glasses of wine, 2 double whiskey) per occasion
Women: 2 or more drinks per occasion (500 mL beer, 1 gou of sake, 350 ml can of shochu, 0.5 gou of shochu, 2 glasses of wine, 1 double shot of whiskey)
3) Have not been diagnosed as an alcoholic at a treatment facility
4) Age between 20 and 65 years old at the time consent is obtained
5) Understand the purpose and content of this study and are able (competent) to obtain consent to participate in the study.

Exclude criteria

1) Patients with a history of severe cerebral organic lesions (with loss of consciousness for more than 10 minutes) or epilepsy, or a history of coexisting or existing epilepsy.
2) A history of or current treatment for a neurodegenerative disease
3) Alcohol withdrawal syndrome with impaired consciousness
4) Dementia or suspected dementia
5) Received support or treatment (health center, mental health center, or hospital) for alcohol problems within 1 year
6) Pregnant
7) identified suicide
8) Other, as deemed inappropriate by the principal investigator

Related Information

• Primary Sponsor: sumiyoshi tomiki
• Source(s) of Monetary Support: Ministry of education