Internet-based vs Face-to-face Treatment for Alcohol Dependence (IMS)

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

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

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence; Alcohol Use Disorder; Alcohol Abuse; Harmful Alcohol Use
• Intervention / Treatment: Behavioral: Guide to better alcohol habits

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.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska Institutet, Department of Public Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based treatment; "Guide to better alcohol habits online". An Internet-based treatment program with online counselor support.	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.; Other Names: Cognitive Behavioral Therapy (CBT); eChange; Motivational Interviewing (MI); Behavioral Self-Control Training
Experimental: Face-to-face treatment; "Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic.	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.; Other Names: Cognitive Behavioral Therapy (CBT); eChange; Motivational Interviewing (MI); Behavioral Self-Control Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Line Follow Back (TLFB)	Change in number of standard drinks per day during last 7 days	3, 6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalised Anxiety Disorder Assessment (GAD-7)	Change in total GAD-7 score, as a summarized measure of anxiety	3, 6, 12 and 24 months
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Session rating scale (SRS)	4 scale questions on the user's alliance with the counselor	2 and 5 weeks in to treatment
Working Alliance Inventory-Short Revised (WAI-SR)	12 questions on working alliance adapted for Internet-based programs	2 and 5 weeks in to treatment

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Sven Andreasson, MD, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Helpful Links

• Clinic website

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: January 17, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: 2014/1758-31/2-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED