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

November 9, 2023 updated by: Anne H Berman, Karolinska Institutet

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Institutet, Department of Public Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet self-help with support
eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules. Patients will have access to Alkoholhjälpen counselor support through secure comments at every module they complete.
Behavioral: Alkoholhjälpen counselor support
Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.
Behavioral: eChange Alkoholhjälpen
An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help
Experimental: Internet self-help
eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules.
Behavioral: eChange Alkoholhjälpen
An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help
Active Comparator: Information
Brief information on resources that can be accessed through the open access website Alkoholhjälpen: Information on alcohol and health, where and how to find treatment and an internet discussion forum.
Behavioral: Alkoholhjälpen
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 6, 12 and 24 months
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, 6, 12 and 24 months
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
3, 6, 12 and 24 months
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
3, 6, 12 and 24 months
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
3, 6, 12 and 24 months
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)
3, 6, 12 and 24 months
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
3, 6, 12 and 24 months
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
3, 6, 12 and 24 months
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
3, 6, 12 and 24 months
Questions about help-seeking behavior
Time Frame: 3, 6, 12 and 24 months
Change in help-seeking for alcohol related problems from professionals
3, 6, 12 and 24 months
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
3, 6, 12 and 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
3, 6, 12 and 24 months
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
From baseline to 3 months
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)
2 and 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm
Public Health Agency of Sweden

Investigators

  • Principal Investigator: Sven Andreasson, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimated)

March 4, 2015

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/1758-31-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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