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

Not Applicable

Completed

• Conditions: Alcohol Abuse; Alcohol Use Disorder; Harmful Alcohol Use; Alcohol Dependence
• Interventions: Behavioral: Alkoholhjälpen counselor support; Behavioral: Alkoholhjälpen; Behavioral: eChange Alkoholhjälpen

• Registration Number: NCT02377726
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Study Start: 2015-04-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1170

Inclusion Criteria

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

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Exclusion Criteria

Inadequate Swedish language skills No Internet access

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet self-help with support	Alkoholhjälpen counselor 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.
Internet self-help with support	eChange Alkoholhjälpen	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.
Internet self-help	eChange Alkoholhjälpen	eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules.
Information	Alkoholhjälpen	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.

Primary Outcome Measures

Name	Time	Method
Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)	3, 6, 12 and 24 months	Change in total in consumption of alcohol last 7 days

Secondary Outcome Measures

Name	Time	Method
Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days)	3, 6, 12 and 24 months	Change in number of standard drinks per day during last 7 days
Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met)	3, 6, 12 and 24 months	Change in number of criteria for alcohol use disorder met
Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days)	3, 6, 12 and 24 months	Change in number of days binge-drinking days during last 7 days
Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)	3, 6, 12 and 24 months	Change in number of criteria for alcohol dependence met
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score)	3, 6, 12 and 24 months	Change in total MADRS-S score, as a summarized measure of depression
Generalised Anxiety Disorder Assessment (GAD-7)	3, 6, 12 and 24 months	Change in total GAD-7 score, as a summarized measure of anxiety
Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends)	3, 6, 12 and 24 months	Change in help-seeking for alcohol related problems from family and friends
Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days)	3, 6, 12 and 24 months	Change in number of consumption days during last 7 days
Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use)	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)
The EuroQol generic health index (EQ5D)	3, 6, 12 and 24 months	Change in total EQ5D score, as a summarized measure of quality of life
Questions about help-seeking behavior	3, 6, 12 and 24 months	Change in help-seeking for alcohol related problems from professionals

Trial Locations

Locations (1)

Karolinska Institutet, Department of Public Health Sciences; 🇸🇪 Stockholm, Sweden