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Completed

NCT Number: NCT02377726

Anonymous Treatment on the Internet for Alcohol Dependence: A Randomised, Controlled Trial

Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.

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Key information

Conditions

Alcohol Abuse Alcohol Dependence Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Harmful Alcohol Use Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Department of Public Health Sciences

Stockholm, 17176, Sweden

About this study

A 5 module Internet based self help program based on motivational interviewing and cognitive behavioral therapy is tested among anonymous Internet help seekers.The design is a three armed randomized controlled study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 2400 participants are recruited entirely online from an open access website. Consenting participants will be randomized into one of three groups: 1.Internet based self help program with counselor support, 2.Internet based self help program without counselor support or 3. Information about the open access websites resources: information on alcohol and health, where you can find treatment and a online discussion forum. Follow-up will be conducted online after 3, 6, 12 and 24 months in all three groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

AUDIT-score >16 points and/or at least 3 criteria of alcohol dependence (ICD-10)

Exclusion criteria

Inadequate Swedish language skills No Internet access

Treatment and study plan

Alkoholhjälpen counselor support

Behavioral

Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.

eChange Alkoholhjälpen

Behavioral

An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help

Alkoholhjälpen

Behavioral

A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum

Other names: alcoholhjalpen.se, alcohol-help-site

Primary outcomes

  1. Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)

    Time frame: 3, 6, 12 and 24 months

    Change in total in consumption of alcohol last 7 days

Secondary outcomes

  1. Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days)

    Time frame: 3, 6, 12 and 24 months

    Change in number of standard drinks per day during last 7 days

  2. Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days)

    Time frame: 3, 6, 12 and 24 months

    Change in number of consumption days during last 7 days

  3. Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days)

    Time frame: 3, 6, 12 and 24 months

    Change in number of days binge-drinking days during last 7 days

  4. Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)

    Time frame: 3, 6, 12 and 24 months

    Change in number of criteria for alcohol dependence met

  5. Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met)

    Time frame: 3, 6, 12 and 24 months

    Change in number of criteria for alcohol use disorder met

  6. Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use)

    Time frame: 3, 6, 12 and 24 months

    Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

  7. Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score)

    Time frame: 3, 6, 12 and 24 months

    Change in total MADRS-S score, as a summarized measure of depression

  8. Generalised Anxiety Disorder Assessment (GAD-7)

    Time frame: 3, 6, 12 and 24 months

    Change in total GAD-7 score, as a summarized measure of anxiety

  9. The EuroQol generic health index (EQ5D)

    Time frame: 3, 6, 12 and 24 months

    Change in total EQ5D score, as a summarized measure of quality of life

  10. Questions about help-seeking behavior

    Time frame: 3, 6, 12 and 24 months

    Change in help-seeking for alcohol related problems from professionals

  11. Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends)

    Time frame: 3, 6, 12 and 24 months

    Change in help-seeking for alcohol related problems from family and friends

Other outcomes

  1. The Readiness Ruler (Scores between 0 and 100)

    Time frame: 3, 6, 12 and 24 months

    Scores between 0 and 100. In this study, "I am not ready to change my drinking habits" and "I am very much ready to change my drinking habits".

  2. Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website)

    Time frame: From baseline to 3 months

    Number of visits and number of completed exercises in the Internet based program and website

  3. Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention )

    Time frame: 2 and 5 weeks

    4 scale questions on the users alliance with the internet based intervention (program and/or website)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Public Health Agency of Sweden
  • Region Stockholm

Registry information

Official study title

Internet Based Treatment for Alcohol Dependence Among Anonymous Help Seekers on the Internet : A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2015
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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