Clinical trial NCT02377726: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Alcohol Dependence
Harmful Alcohol Use
Alcohol Use Disorder
Keywords: Randomized Controlled Trial
Alcohol
Internet
Internet based therapy
Cognitive behavioral therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Sweden
name: Region Stockholm
First posted: 2015-03-04
Enrollment: 1170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)
timeFrame: 3, 6, 12 and 24 months
Secondary outcomes:
measure: Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days)
timeFrame: 3, 6, 12 and 24 months
measure: Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days)
timeFrame: 3, 6, 12 and 24 months
measure: Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days)
timeFrame: 3, 6, 12 and 24 months
measure: Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)
timeFrame: 3, 6, 12 and 24 months
measure: Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met)
timeFrame: 3, 6, 12 and 24 months
measure: Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use)
timeFrame: 3, 6, 12 and 24 months
measure: Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score)
timeFrame: 3, 6, 12 and 24 months
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 3, 6, 12 and 24 months
measure: The EuroQol generic health index (EQ5D)
timeFrame: 3, 6, 12 and 24 months
measure: Questions about help-seeking behavior
timeFrame: 3, 6, 12 and 24 months
measure: Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends)
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
measure: The Readiness Ruler (Scores between 0 and 100)
timeFrame: 3, 6, 12 and 24 months
measure: Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website)
timeFrame: From baseline to 3 months
measure: Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention )
timeFrame: 2 and 5 weeks
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Public Health Sciences
Study officials:
affiliation: Karolinska Institutet
name: Sven Andreasson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.