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

Primary Purpose

Alcohol Abuse, Alcohol Dependence, Harmful Alcohol Use

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Alkoholhjälpen counselor support
eChange Alkoholhjälpen
Alkoholhjälpen
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet, Department of Public Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Internet self-help with support

Internet self-help

Information

Arm Description

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.

eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)
Change in number of criteria for alcohol dependence met
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
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)
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
Generalised Anxiety Disorder Assessment (GAD-7)
Change in total GAD-7 score, as a summarized measure of anxiety
The EuroQol generic health index (EQ5D)
Change in total EQ5D score, as a summarized measure of quality of life
Questions about help-seeking behavior
Change in help-seeking for alcohol related problems from professionals
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

Full Information

First Posted
February 26, 2015
Last Updated
September 1, 2020
Sponsor
Karolinska Institutet
Collaborators
Public Health Agency of Sweden, Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT02377726
Brief Title
Anonymous Treatment on the Internet for Alcohol Dependence: A Randomised, Controlled Trial
Official Title
Internet Based Treatment for Alcohol Dependence Among Anonymous Help Seekers on the Internet : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Public Health Agency of Sweden, Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence, Harmful Alcohol Use, Alcohol Use Disorder
Keywords
Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet self-help with support
Arm Type
Experimental
Arm Description
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.
Arm Title
Internet self-help
Arm Type
Experimental
Arm Description
eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules.
Arm Title
Information
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Alkoholhjälpen counselor support
Intervention Description
Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.
Intervention Type
Behavioral
Intervention Name(s)
eChange Alkoholhjälpen
Intervention Description
An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help
Intervention Type
Behavioral
Intervention Name(s)
Alkoholhjälpen
Other Intervention Name(s)
alcoholhjalpen.se, alcohol-help-site
Intervention Description
A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum
Primary Outcome Measure Information:
Title
Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)
Description
Change in total in consumption of alcohol last 7 days
Time Frame
3, 6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days)
Description
Change in number of standard drinks per day during last 7 days
Time Frame
3, 6, 12 and 24 months
Title
Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days)
Description
Change in number of consumption days during last 7 days
Time Frame
3, 6, 12 and 24 months
Title
Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days)
Description
Change in number of days binge-drinking days during last 7 days
Time Frame
3, 6, 12 and 24 months
Title
Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)
Description
Change in number of criteria for alcohol dependence met
Time Frame
3, 6, 12 and 24 months
Title
Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met)
Description
Change in number of criteria for alcohol use disorder met
Time Frame
3, 6, 12 and 24 months
Title
Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use)
Description
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Time Frame
3, 6, 12 and 24 months
Title
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score)
Description
Change in total MADRS-S score, as a summarized measure of depression
Time Frame
3, 6, 12 and 24 months
Title
Generalised Anxiety Disorder Assessment (GAD-7)
Description
Change in total GAD-7 score, as a summarized measure of anxiety
Time Frame
3, 6, 12 and 24 months
Title
The EuroQol generic health index (EQ5D)
Description
Change in total EQ5D score, as a summarized measure of quality of life
Time Frame
3, 6, 12 and 24 months
Title
Questions about help-seeking behavior
Description
Change in help-seeking for alcohol related problems from professionals
Time Frame
3, 6, 12 and 24 months
Title
Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends)
Description
Change in help-seeking for alcohol related problems from family and friends
Time Frame
3, 6, 12 and 24 months
Other Pre-specified Outcome Measures:
Title
The Readiness Ruler (Scores between 0 and 100)
Description
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".
Time Frame
3, 6, 12 and 24 months
Title
Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website)
Description
Number of visits and number of completed exercises in the Internet based program and website
Time Frame
From baseline to 3 months
Title
Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention )
Description
4 scale questions on the users alliance with the internet based intervention (program and/or website)
Time Frame
2 and 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Andreasson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of Public Health Sciences
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25300885
Citation
Sinadinovic K, Wennberg P, Johansson M, Berman AH. Targeting individuals with problematic alcohol use via Web-based cognitive-behavioral self-help modules, personalized screening feedback or assessment only: a randomized controlled trial. Eur Addict Res. 2014;20(6):305-18. doi: 10.1159/000362406. Epub 2014 Oct 4.
Results Reference
background
PubMed Identifier
34821563
Citation
Johansson M, Berman AH, Sinadinovic K, Lindner P, Hermansson U, Andreasson S. Effects of Internet-Based Cognitive Behavioral Therapy for Harmful Alcohol Use and Alcohol Dependence as Self-help or With Therapist Guidance: Three-Armed Randomized Trial. J Med Internet Res. 2021 Nov 24;23(11):e29666. doi: 10.2196/29666.
Results Reference
derived
Links:
URL
https://alkoholhjalpen.se
Description
Open access website
URL
http://ki.se/people/anberm
Description
Berman's research group profile

Learn more about this trial

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

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