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Exploratory trial of non-face-to-face cognitive behavioural therapy to improve addiction symptoms of alcohol use disorder

A multicenter, prospective, comparative, single-blind, randomized, exploratory clinical trial to evaluate the safety and efficacy of digital cognitive behavioral therapy software improving addiction symptoms in patients with alcohol use disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010289
Enrollment
50
Registered
2025-03-12
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Intervention Description: A web program treatment device based on Cognitive Behavior Therapy (CBT) interventions for the treatment of alcohol use disorder symptoms in patients with me

Sponsors

Hallym University Medical Center- Chuncheon
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Adults aged 19 or older ? Individuals who meet the diagnostic criteria for Alcohol Use Disorder (AUD) based on the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) or have been diagnosed with Mental and Behavioral Disorders due to Alcohol Use (F10) according to the ICD-10. ? Individuals who have no difficulty reading and writing in Korean. ? Individuals who can comfortably use a web-based digital therapeutic device on general-purpose equipment (e.g., computer, laptop, or tablet PC). ? Individuals who have received a full explanation of this clinical trial, understand its purpose, voluntarily agree to participate, and provide written informed consent while committing to comply with study guidelines. ? Individuals with no history of dementia. ? For women of childbearing potential*: Individuals who agree to use medically approved contraception** during the clinical trial period. Women of childbearing potential: Women who have experienced menarche and are capable of becoming pregnant. Women who have undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or have experienced natural menopause (defined as 12 consecutive months of amenorrhea without an alternative medical cause) are not considered of childbearing potential. Medically approved contraception methods include: Hormonal contraception, Intrauterine device (IUD) or intrauterine system (IUS), Tubal ligation, Dual barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge), Single barrier methods combined with spermicide ? Individuals or their legally authorized representatives who have received a full explanation of the clinical trial, fully understand its details, voluntarily decide to participate, and provide written informed consent.

Exclusion criteria

Exclusion criteria: ? Any advanced, severe, progressive, or unstable disease that could put the patient at risk. ? Any medical or other neurological conditions that could explain cognitive decline(e.g., post-traumatic conditions, Huntington's disease, multiple sclerosis, cerebral palsy, encephalitis, meningitis, or any diseases affecting the central nervous system). ? Individuals with neurodegenerative diseases other than depression or those with severe psychiatric symptoms that may hinder their cooperation in the clinical trial. ? Individuals currently having uncontrolled seizure disorders. ? Individuals with a history of brain injury resulting in a loss of consciousness for more than 1 hour or hospitalization within the past 3 years. ? Hearing or vision impairments that may interfere with the performance of the required tasks in the clinical trial. ? Pregnant or breastfeeding women. ? Women of childbearing potential who plan to become pregnant during the clinical trial period. ? Individuals who are currently participating in another clinical trial or have participated in another clinical trial within 30 days prior to the screening date. ? Individuals deemed unsuitable for the study according to the judgment of the investigator.

Design outcomes

Primary

MeasureTime frame
Abstinence success rate (drinking frequency and alcohol consumption) during the 5- to 8-week treatment period.

Secondary

MeasureTime frame
Satisfaction with treatment, safety of treatment;Record a sobriety diary, Treatment retention rates;Scores on addiction-related clinical characteristic scales during the treatment period (8 weeks): Self-report questionnaires, including the Alcohol Urge Scale (AUDIT-K), which measures alcohol craving.

Countries

Korea, Republic of

Contacts

Public ContactEunji Lee

Hallym University Medical Center- Chuncheon

qkq1616@naver.com+82-33-240-5172

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026