Internet-based vs Face-to-face Treatment for Alcohol Dependence

Alcohol Use Disorder Clinical Trial

— IMS  

Official title:

Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888002
• Other study ID #: 2014/1758-31/2-2
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: March 30, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Harmful Alcohol Use

Intervention

Behavioral:
• Guide to better alcohol habits
A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

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. In this study, "How ready to change reduce my drinking" and "How ready to quit drinking".	3, 6, 12 and 24 month
Other	Use of 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	Session rating scale (SRS)	4 scale questions on the user's alliance with the counselor	2 and 5 weeks in to treatment
Other	Working Alliance Inventory-Short Revised (WAI-SR)	12 questions on working alliance adapted for Internet-based programs	2 and 5 weeks in to treatment
Primary	Time Line Follow Back (TLFB)	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	Change in number of drinking 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	Change in number of binge-drinking days during last 7 days	3, 6, 12 and 24 months
Secondary	Alcohol Use Disorders Identification Test Consumption (AUDIT-C)	Change in Quantity, Frequency and Binge-drinking scores during the time since last reported	3, 6, 12 and 24 months
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	Change in total AUDIT score, as a summarized measure of alcohol use since last reported	3, 6, 12 and 24 months
Secondary	Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)	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	Questions about help-seeking behavior from family and friends	Change in help-seeking for alcohol related problems from family and friends. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., & Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387	3, 6, 12 and 24 months
Secondary	Questions about help-seeking behavior from professionals	Change in help-seeking for alcohol related problems from professionals. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., & Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387	3, 6, 12 and 24 months

External Links

•   Clinic website