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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02377726
Other study ID # 2014/1758-31-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2015
Est. completion date November 30, 2019

Study information

Verified date November 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1170
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
eChange Alkoholhjälpen
An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help
Alkoholhjälpen
A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum

Locations

Country Name City State
Sweden Karolinska Institutet, Department of Public Health Sciences Stockholm

Sponsors (3)

Lead Sponsor Collaborator
Karolinska Institutet Public Health Agency of Sweden, Region Stockholm

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other The Readiness Ruler (Scores between 0 and 100) 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
Other Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website) Number of visits and number of completed exercises in the Internet based program and website From baseline to 3 months
Other Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention ) 4 scale questions on the users alliance with the internet based intervention (program and/or website) 2 and 5 weeks
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Generalised Anxiety Disorder Assessment (GAD-7) Change in total GAD-7 score, as a summarized measure of anxiety 3, 6, 12 and 24 months
Secondary 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
Secondary Questions about help-seeking behavior Change in help-seeking for alcohol related problems from professionals 3, 6, 12 and 24 months
Secondary 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
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