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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
303
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.
Karolinska Institutet
Stockholm, Sweden
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 3 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 6 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 12 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 24 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 3 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 6 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 12 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 24 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 3 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 6 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 12 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 24 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 3 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 6 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 12 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 24 months post-randomization
Number of days absent from work due to illness
Time frame: 3 months post-randomization
Number of days absent from work due to illness
Time frame: 6 months post-randomization
Number of days absent from work due to illness
Time frame: 12 months post-randomization
Number of days absent from work due to illness
Time frame: 24 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 3 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 6 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 12 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 24 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 3 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 6 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 12 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 24 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 3 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 6 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 12 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 24 months post-randomization
Cost for treatment
Time frame: 3 months post-randomization
Cost for treatment
Time frame: 6 months post-randomization
Cost for treatment
Time frame: 12 months post-randomization
Cost for treatment
Time frame: 24 months post-randomization
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