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临床试验/NCT06739109
NCT06739109进行中(未招募)不适用

Guided Internet-Based Treatment for Harmful Alcohol Use; eBehandling Alkohol

Sykehuset i Vestfold HF10 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250
试验地点
10
主要终点
Changes in mental health status

研究概览

简要总结

Guided internet-based treatment for individuals with harmful alcohol use, eBehandling Alkohol (eBA), will be implemented as an experimental treatment option in five hospitals autumn 2024. Concurrently, a research project related to the effects of eBA will be conducted. Results from a pilot project show that treatment with eBA can help reduce alcohol use and improve mental health among people with harmful alcohol consumption. Similar results have been found in other international studies.

Many individuals with harmful alcohol consumption avoid seeking treatment, leading to negative consequences for the individual, their families, and society. The pilot project indicates that guided internet-based treatment is an effective treatment that is easily accessible and cost-effective. Access to eBA can help circumvent shame and stigma, increase access to treatment, reduce alcohol use, and improve physical and mental health.

Individuals who wish to participate in eBA do not need a referral from a GP. After an initial screening, participants will be given access to eBA, which consists of 9 treatment modules to be completed over an 8-12-week period, upon giving their consent. Participants will be followed up 4 weeks, 6 months, and 2 years after the completion of treatment. Data will be collected during screening, throughout the treatment period, and post-treatment. Data will be collected in the form of questionnaires, interviews, and registry data.

Simultaneously with the implementation of eBA as an experimental treatment, this project aims to investigate the characteristics of participants who apply for eBA, as well as examine the effects eBA may have in terms of reducing alcohol use, improving physical and mental health, and enhancing the quality of life among participants. The overarching goal of the study is to strengthen the understanding of the effects of internet-based treatment, thereby providing a sufficient basis to assess whether eBA should be implemented as a regular treatment option.

The study will also be part of a larger collaborative project where we will conduct meta-analyses of results from eBA and two other studies that also include treatment programs aimed at individuals with varying degrees of alcohol problems: the "Predictor Study" and "Endre". The three treatment programs are aimed at individuals who are at different stages in their problem trajectory. The goal of this collaborative project is to contribute to the development of a more holistic and targeted treatment offer for individuals with varying degrees of problem development.

详细描述

Introduction Harmful alcohol use is a pressing issue that affects individuals, families, and society as a whole, posing a significant public health problem. For the individual, harmful alcohol use can lead to mental and physical health issues, as well as social and relational problems. From a societal perspective, it can result in reduced work capacity, increased sickness absence, crime, violence, accidents, and injuries. In Norway, at least 17% of the adult population engages in potentially harmful alcohol consumption. This leads to many inpatient stays in both somatic and psychiatric hospitals. Reducing high alcohol consumption can yield substantial health benefits and significant societal savings.

The public health services for alcohol use disorder in Norway fall within the interdisciplinary specialized addiction treatment (Tverrfaglig Spesialisert Rusbehandling; TSB). TSB offers various treatment options, predominantly outpatient treatments through individual or group therapy sessions. An ongoing study at Vestfold Hospital Trust, titled "Patient factors predicting completion and outcome in group treatment of alcohol use disorders" (the "Predictor study"), explores how patient factors (psychological, sociodemographic, and societal) predict outcomes in group treatment for alcohol use disorders (AUD). This study tracks participants through approximately 3 months of treatment and follows up at 1 and 3 years post-treatment.

Despite available treatments, a significant proportion of people with emerging alcohol problems do not seek help early on, missing the opportunity for early intervention. The reasons for this reluctance are varied and complex. Feelings of shame and guilt over having an emerging alcohol problem can prevent some individuals from seeking health care. Additionally, treatment may be inaccessible, or the available treatment options may not be tailored to the individual's needs. Common barriers include the necessity for GP referrals for TSB treatments, the prioritization of treatment for severe cases of alcohol use, financial constraints, and the logistical challenges of traveling to outpatient clinics while balancing studies, work, or family responsibilities.

Needs Description eBA (eBehandling Alkohol) is a guided internet-based treatment for problematic alcohol use, developed through a collaboration between Vestfold Hospital Trust and Haukeland University Hospital. The treatment is grounded in cognitive behavioral therapy (CBT) and motivational interviewing (MI). It provides patients with access to self-help modules containing information, questionnaires, and tools useful for the process of reducing alcohol use. Patients regularly complete questionnaires that measure changes in alcohol use, other drug use, physical and mental health, and quality of life. These questionnaires are integrated into the treatment program and help therapists monitor and adjust the treatment. Patients can use their questionnaire results to assess whether the treatment is helping them achieve their goals. In the planned research project, data from these questionnaires will be utilized to answer the research questions. Patients are guided by therapists through written messages in the treatment program or by telephone.

One of the main advantages of eBA is the potential to offer treatment for harmful alcohol use at an early stage, thus preventing further deterioration of the problem. This is invaluable for individuals, their families, and society. eBA is easily accessible, discrete, and can lower the threshold for seeking help by reducing stigma, financial barriers, and logistical difficulties.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Harmful alcohol use
  • Willing to make an effort to reduce alcohol consumption
  • Able to use guided internet-based treatment
  • Access to a computer, tablet, or smartphone
  • Access to BankID or equivalent secure log-in

排除标准

  • * Acute and/or severe mental disorders, such as psychotic issues or ongoing suicidal issues.

研究组 & 干预措施

eBA intervention

Experimental

Adults with harmful alcohol use will be offered to complete a therapy-guided internet based intervention.

干预措施: Therapy-guided internet-based treatment program (Procedure)

结局指标

主要结局

Changes in mental health status

时间窗: Measure changes from baseline to end of treatment, and 6 months and 2 years post-treatment

Measure changes in SCL-10R (Symptom Check List) scores on a scale from 1 to 4, the higher score the wore outcome.

Identifying characteristics of people seeking eBA

时间窗: Baseline measure

Describe demographics, age, sex, education, occupation, main source of income, marital status, children, duration of problem, previous treatment experience

Changes in alcohol use

时间窗: Measure changes from baseline to end of treatment, and 6 months and 2 years post-treatment

Measure changes using the Alcohol Use Disorder Scale (AUDIT ), reporting on a sum score scale from 0 to 40; higher score indicate worse outcome.

Changes in quality of life

时间窗: Measure changes from baseline to end of treatment, and 6 months and 2 years post-treatment

Measure changes in 5Q-5D-5L (quality of life ), including av visual analoge scale (VAS). The 5Q-5D-5L scores on a scale from 1 to 5, were high score indicate worse outcome. The instrument includes a VAS from 0 to 100, where higher score indicate better outcome.

次要结局

  • Compare participants characteristics in the eBA study, the Predictor Study and the Endre study(Baseline measure)
  • Compare retention in treatment in eBA to standard group-treatment in the Predictor study and the Endre program(End of treatment program)
  • Compare changes in alcohol use between participants in the eBA study, the Predictor study and the Endre study(Measure changes from baseline to end of treatment, and 6 months and 2 years post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Klemmetsby Solli

Project leader

Sykehuset i Vestfold HF

研究点 (10)

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