Clinical trial NCT02888002: Internet-based vs Face-to-face Treatment for Alcohol Dependence
Official title: Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Alcohol Dependence
Harmful Alcohol Use
Alcohol Use Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2016-09-02
Enrollment: 310
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: A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.

Detailed description: A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority 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. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Risk of severe withdrawal symptoms.
* Risk of suicide.
* Other psychiatric diagnosis that requires current treatment.
* Need for medication for alcohol dependence.
* Inadequate Swedish language skills.
* No Internet access

Primary outcomes:
measure: Time Line Follow Back (TLFB)
timeFrame: 3, 6, 12 and 24 months
Secondary outcomes:
measure: Time Line Follow Back (TLFB) Change in number of consumption days
timeFrame: 3, 6, 12 and 24 months
measure: Time Line Follow Back (TLFB) Change in number of days binge-drinking days
timeFrame: 3, 6, 12 and 24 months
measure: Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
timeFrame: 3, 6, 12 and 24 months
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 3, 6, 12 and 24 months
measure: Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
timeFrame: 3, 6, 12 and 24 months
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 3, 6, 12 and 24 months
measure: Questions about help-seeking behavior from family and friends
timeFrame: 3, 6, 12 and 24 months
measure: Questions about help-seeking behavior from professionals
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
measure: The Readiness Ruler
timeFrame: 3, 6, 12 and 24 month
measure: Use of Internet-based program and website
timeFrame: From baseline to 3 months
measure: Session rating scale (SRS)
timeFrame: 2 and 5 weeks in to treatment
measure: Working Alliance Inventory-Short Revised (WAI-SR)
timeFrame: 2 and 5 weeks in to treatment
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Public Health Sciences
Study officials:
affiliation: Karolinska Institutet
name: Sven Andreasson, MD, 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.