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

Not Applicable

• Conditions: Alcohol Use Disorders
• Interventions: Behavioral: Guide to better alcohol habits

• Registration Number: NCT02671019
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-30
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 303

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based treatment	Guide to better alcohol habits	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.
Face-to-face treatment	Guide to better alcohol habits	Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	24 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	24 months post-randomization
Number of days absent from work due to illness	24 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale	24 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale	24 months post-randomization
Score on EQ-5D measuring the quality of life	24 months post-randomization
Cost for treatment	24 months post-randomization

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden