Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
11 septembre 2026 mis à jour par: Kristina Sinadinovic, Karolinska Institutet
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:
- 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
303
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Stockholm, Suède, 171 77
- Karolinska Institutet
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Délai: 3 months post-randomization
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3 months post-randomization
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Délai: 6 months post-randomization
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6 months post-randomization
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Délai: 12 months post-randomization
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12 months post-randomization
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Délai: 24 months post-randomization
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24 months post-randomization
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Alcohol Use Disorders Identification Test score
Délai: 3 months post-randomization
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3 months post-randomization
|
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Alcohol Use Disorders Identification Test score
Délai: 6 months post-randomization
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6 months post-randomization
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Alcohol Use Disorders Identification Test score
Délai: 12 months post-randomization
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12 months post-randomization
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Alcohol Use Disorders Identification Test score
Délai: 24 months post-randomization
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24 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Délai: 3 months post-randomization
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3 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Délai: 6 months post-randomization
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6 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Délai: 12 months post-randomization
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12 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Délai: 24 months post-randomization
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24 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Délai: 3 months post-randomization
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3 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Délai: 6 months post-randomization
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6 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Délai: 12 months post-randomization
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12 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Délai: 24 months post-randomization
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24 months post-randomization
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Number of days absent from work due to illness
Délai: 3 months post-randomization
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3 months post-randomization
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Number of days absent from work due to illness
Délai: 6 months post-randomization
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6 months post-randomization
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Number of days absent from work due to illness
Délai: 12 months post-randomization
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12 months post-randomization
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Number of days absent from work due to illness
Délai: 24 months post-randomization
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24 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
Délai: 3 months post-randomization
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3 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
Délai: 6 months post-randomization
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6 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
Délai: 12 months post-randomization
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12 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
Délai: 24 months post-randomization
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24 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
Délai: 3 months post-randomization
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3 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
Délai: 6 months post-randomization
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6 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
Délai: 12 months post-randomization
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12 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
Délai: 24 months post-randomization
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24 months post-randomization
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Score on EQ-5D measuring the quality of life
Délai: 3 months post-randomization
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3 months post-randomization
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Score on EQ-5D measuring the quality of life
Délai: 6 months post-randomization
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6 months post-randomization
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Score on EQ-5D measuring the quality of life
Délai: 12 months post-randomization
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12 months post-randomization
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Score on EQ-5D measuring the quality of life
Délai: 24 months post-randomization
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24 months post-randomization
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Cost for treatment
Délai: 3 months post-randomization
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3 months post-randomization
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Cost for treatment
Délai: 6 months post-randomization
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6 months post-randomization
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Cost for treatment
Délai: 12 months post-randomization
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12 months post-randomization
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Cost for treatment
Délai: 24 months post-randomization
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24 months post-randomization
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 novembre 2015
Achèvement primaire (Réel)
31 mars 2020
Achèvement de l'étude (Réel)
31 mars 2025
Dates d'inscription aux études
Première soumission
11 janvier 2016
Première soumission répondant aux critères de contrôle qualité
1 février 2016
Première publication (Estimé)
2 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2014/1758-31/2
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .