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

29. Mai 2019 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

303

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Schweden
      • Stockholm, Schweden, 171 77
        • Karolinska Institutet

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.
Aktiver Komparator: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Karolinska Institutet

Mitarbeiter

Region Stockholm

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2015

Primärer Abschluss (Voraussichtlich)

1. Dezember 2019

Studienabschluss (Voraussichtlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

11. Januar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Februar 2016

Zuerst gepostet (Schätzen)

2. Februar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Mai 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2019

Zuletzt verifiziert

1. Mai 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2014/1758-31/2

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