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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alcohol Abuse, Alcohol Dependence, Harmful Alcohol Use, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Alkoholhjälpen counselor support
* Behavioral: eChange Alkoholhjälpen
* Behavioral: Alkoholhjälpen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet self-help with support<br>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<br>* Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.<br>Behavioral: eChange Alkoholhjälpen<br>* An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help<br>|
| Experimental: Internet self-help<br>eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules. | Behavioral: eChange Alkoholhjälpen<br>* An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help<br>|
| Active Comparator: Information<br>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<br>* A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum<br>* Other names: alcoholhjalpen.se, alcohol-help-site;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Change in total MADRS-S score, as a summarized measure of depression | 3, 6, 12 and 24 months | 
| Generalised Anxiety Disorder Assessment (GAD-7) | Change in total GAD-7 score, as a summarized measure of anxiety | 3, 6, 12 and 24 months | 
| The EuroQol generic health index (EQ5D) | Change in total EQ5D score, as a summarized measure of quality of life | 3, 6, 12 and 24 months | 
| Questions about help-seeking behavior | 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) | Change in help-seeking for alcohol related problems from family and friends | 3, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy