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

Study Overview
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Brief Summary
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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: 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. 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.

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

Conditions
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Alcohol Use Disorders

Intervention / Treatment
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* Behavioral: Guide to better alcohol habits


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based treatment<br>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<br>* 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.<br>|
| Active Comparator: Face-to-face treatment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |