Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care

Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial

The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:

1. The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
2. The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.

The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:

Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.

Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.

Study Overview

• Status: Unknown
• Conditions: Alcohol Use Disorders
• Intervention / Treatment: Behavioral: Guide to better alcohol habits

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 77
    • Karolinska Institutet

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:

• 18 years or older
• 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
• Resident in Stockholm County

Exclusion Criteria:

• Lack of understanding of the Swedish language.
• Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
• Doctor's assessment that there is a need for medication for alcohol dependence.

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; A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.	Behavioral: Guide to better alcohol habits; A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
Active Comparator: Face-to-face treatment; Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.	Behavioral: Guide to better alcohol habits; A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method	3 months post-randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method	6 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method	12 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method	24 months post-randomization
Alcohol Use Disorders Identification Test score	3 months post-randomization
Alcohol Use Disorders Identification Test score	6 months post-randomization
Alcohol Use Disorders Identification Test score	12 months post-randomization
Alcohol Use Disorders Identification Test score	24 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10	3 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10	6 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10	12 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10	24 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V	3 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V	6 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V	12 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V	24 months post-randomization
Number of days absent from work due to illness	3 months post-randomization
Number of days absent from work due to illness	6 months post-randomization
Number of days absent from work due to illness	12 months post-randomization
Number of days absent from work due to illness	24 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale	3 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale	6 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale	12 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale	24 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale	3 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale	6 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale	12 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale	24 months post-randomization
Score on EQ-5D measuring the quality of life	3 months post-randomization
Score on EQ-5D measuring the quality of life	6 months post-randomization
Score on EQ-5D measuring the quality of life	12 months post-randomization
Score on EQ-5D measuring the quality of life	24 months post-randomization
Cost for treatment	3 months post-randomization
Cost for treatment	6 months post-randomization
Cost for treatment	12 months post-randomization
Cost for treatment	24 months post-randomization

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

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