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

NCT06739109 | Recruiting

• 2 other identifiers: eBehandling AlkoholREK no 672168
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Harmful Alcohol Use

Keywords

Internet based treatment; Guided internet treatment; Alcohol use

Outcome Measures

Primary Outcomes (6)

• Identifying characteristics of people seeking eBA

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

  Baseline measure

• Changes in alcohol use

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

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

• Changes in mental health status

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

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

• Changes in mental health status

  Measure changes using GAD-7 (Generalized Anxiety Disorder), reporting on a scale from 0 to 3; higher score indicating worse outcome.

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

• Changes in quality of life

  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.

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

• Changes in quality of life

  Measure changes in WHO quality of life score (WHOQOL-1) on a scale from 1 to 5, where higher scores indicate better outcome.

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

Secondary Outcomes (3)

• 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

Study Arms (1)

eBA intervention

EXPERIMENTAL

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

Procedure: Therapy-guided internet-based treatment program

Interventions

Therapy-guided internet-based treatment program PROCEDURE

eBA is a guided internet-based treatment for problematic alcohol use, based on cognitive behavioural therapy and motivational interview. The patients get access to self-help modules with information, questionnaires, and tools useful in a process of reducing alcohol use. Questionnaires measuring changes in alcohol use, illicit drug use, physical and mental health, and quality of life are frequently answered. These questionnaires are an integrated part of the treatment program and are used by the therapist to monitor and adjust the treatment according to each patient. The patients use the results from the questionnaires to assess whether the treatment is helpful reaching the treatment goal. The patients are guided by a therapist, and they communicate using a system for written messages in the treatment program and/ or guided by telephone.

eBA intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sykehuset i Vestfold HF: lead
• Sykehuset Innlandet HF: collaborator
• University Hospital, Akershus: collaborator
• Hospital of Southern Norway Trust: collaborator
• Trondheim University Hospital: collaborator

Study Sites (5)

Sørlandet Hospital Trust (Hospital of Kristiansand)

Kristiansand, Agder, 4604, Norway

NOT YET RECRUITING

Akershus University Hospital

Loerenskog, Akershus, 1478, Norway

RECRUITING

Innlandet Hospital Trust

Lillehammer, Innlandet, 2629, Norway

RECRUITING

St. Olavs Hospital

Trondheim, Trøndelag, 7006, Norway

RECRUITING

Vestfold Hospital Trust

Tønsberg, Vestfold, 3103, Norway

RECRUITING

Related Links

• Information about the eBA intervention in the Web sites of Vestfold Hospital Trust

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Kristin K Solli, PhD

  Sykehuset i Vestfold HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin K Solli, PhD

CONTACT

+4747905895; krsoll@siv.no

Elin K Vestly, BSc

CONTACT

+4747906120; veseli@siv.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 18, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)