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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based treatment | Experimental | 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 | Active Comparator | Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guide to better alcohol habits | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 171 77 | Sweden |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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 |