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The Pilot Study on Development and Effectiveness of an Executive Function Improvement Program for Alcohol-Use Disorder-With an Understanding of Difficulties in Living-

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Alcoholism or Alcohol use disorder
Date of first enrollment	13/02/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	This program is a group based cognitive training program called Ninto-re Cognitive Training. The intervention consists of a total of 12 sessions, including one initial session for goal setting and orientation, ten cognitive training sessions aimed at improving cognitive functions, and one final verbal session. The program was newly developed by the principal investigator based on occupational therapy theories for higher brain dysfunction and evidence from cognitive rehabilitation programs for alcohol use disorder implemented overseas. The program focuses on executive dysfunction, which is a core cognitive impairment in individuals with alcohol use disorder, and promotes goal oriented planning by providing instructions that direct participants attention to executive functions and enhance self awareness. A structured program enables participants to identify and repeatedly practice cognitive strategies for managing cognitive impairments. Written reflection is incorporated to facilitate verbalization of strategies and visualization of learning outcomes. The combination of cognitive training and verbal sessions promotes generalization of cognitive strategies to daily life. Clinically applicable occupational activities commonly used in psychiatric occupational therapy and day care settings are employed to enhance participant engagement. Each session includes a Ninto-re Game as a warm up task and a Ninto-re Activity as activity based cognitive training. The Ninto-re Game involves group based cognitive tasks such as route finding using railway maps and timetables. The Ninto-re Activity consists of structured occupational activities using existing kits such as woodworking and stained glass art, during which participants create two to three products over the ten training sessions. Task procedures are divided into step by step instructions, and participants are encouraged to read each instruction aloud, confirm understanding, and then execute the task sequentially.

Outcome(s)

Primary Outcome

Executive function will be assessed using the Frontal Assessment Battery (FAB). The total score will be measured before and after the intervention to evaluate the effectiveness of the program.

Secondary Outcome

Secondary outcomes include attention (Trail Making Test), impulsivity (Stroop Test), self-efficacy (General Self-Efficacy Scale), and executive function (Zoo Map Test and Modified Six Elements Test of the Behavioural Assessment of the Dysexecutive Syndrome), assessed before and after the intervention. Global cognitive function will be screened using the Montreal Cognitive Assessment Japanese version (MoCA-J). Qualitative data on perceived changes in difficulties in daily life will be collected through semi-structured focus group and individual interviews after the intervention.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Patients who meet all of the following criteria will be included: Patients diagnosed with alcohol dependence or alcohol use disorder. Patients aged 20 to 65 years. Patients who are currently employed or who wish to be employed in the future. Patients living in the community.
Exclude criteria	Patients who meet any of the following criteria will be excluded: Patients diagnosed with dementia, including alcohol-related dementia (patients scoring 20 points or below on the Montreal Cognitive Assessment [MoCA] will be excluded). Patients with a history of or a diagnosis of organic brain disorders, such as cerebral infarction or traumatic brain injury. Patients diagnosed with psychiatric disorders, including schizophrenia, mood disorders, or neurodevelopmental disorders. Patients deemed inappropriate for participation in the study by the principal investigator or co-investigators. Patients who are judged by the responsible personnel at the participating facility to be unable to continue participation in the study due to poor physical condition or unstable mental status