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

11 september 2026 bijgewerkt door: 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:

  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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

303

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Zweden
      • Stockholm, Zweden, 171 77
        • Karolinska Institutet

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Guide to better alcohol habits
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.
Actieve vergelijker: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
Gedragsmatig: Guide to better alcohol habits
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tijdsspanne: 3 months post-randomization
3 months post-randomization

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Alcohol Use Disorders Identification Test score
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Alcohol Use Disorders Identification Test score
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Alcohol Use Disorders Identification Test score
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Alcohol Use Disorders Identification Test score
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Number of days absent from work due to illness
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Number of days absent from work due to illness
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Number of days absent from work due to illness
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Number of days absent from work due to illness
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Score on EQ-5D measuring the quality of life
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Score on EQ-5D measuring the quality of life
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Score on EQ-5D measuring the quality of life
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Score on EQ-5D measuring the quality of life
Tijdsspanne: 24 months post-randomization
24 months post-randomization
Cost for treatment
Tijdsspanne: 3 months post-randomization
3 months post-randomization
Cost for treatment
Tijdsspanne: 6 months post-randomization
6 months post-randomization
Cost for treatment
Tijdsspanne: 12 months post-randomization
12 months post-randomization
Cost for treatment
Tijdsspanne: 24 months post-randomization
24 months post-randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Karolinska Institutet

Medewerkers

Region Stockholm

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 november 2015

Primaire voltooiing (Werkelijk)

31 maart 2020

Studie voltooiing (Werkelijk)

31 maart 2025

Studieregistratiedata

Eerst ingediend

11 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

1 februari 2016

Eerst geplaatst (Geschat)

2 februari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

11 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2014/1758-31/2

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