Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
29. maj 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
303
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Stockholm, Sverige, 171 77
- Karolinska Institutet
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv 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.
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tidsramme: 3 months post-randomization
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3 months post-randomization
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months post-randomization
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24 months post-randomization
|
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Alcohol Use Disorders Identification Test score
Tidsramme: 3 months post-randomization
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3 months post-randomization
|
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Alcohol Use Disorders Identification Test score
Tidsramme: 6 months post-randomization
|
6 months post-randomization
|
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Alcohol Use Disorders Identification Test score
Tidsramme: 12 months post-randomization
|
12 months post-randomization
|
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Alcohol Use Disorders Identification Test score
Tidsramme: 24 months post-randomization
|
24 months post-randomization
|
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months post-randomization
|
24 months post-randomization
|
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months post-randomization
|
24 months post-randomization
|
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Number of days absent from work due to illness
Tidsramme: 3 months post-randomization
|
3 months post-randomization
|
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Number of days absent from work due to illness
Tidsramme: 6 months post-randomization
|
6 months post-randomization
|
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Number of days absent from work due to illness
Tidsramme: 12 months post-randomization
|
12 months post-randomization
|
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Number of days absent from work due to illness
Tidsramme: 24 months post-randomization
|
24 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
Tidsramme: 3 months post-randomization
|
3 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
Tidsramme: 6 months post-randomization
|
6 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
Tidsramme: 12 months post-randomization
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12 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
Tidsramme: 24 months post-randomization
|
24 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
Tidsramme: 3 months post-randomization
|
3 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
Tidsramme: 6 months post-randomization
|
6 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
Tidsramme: 12 months post-randomization
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12 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months post-randomization
|
6 months post-randomization
|
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Score on EQ-5D measuring the quality of life
Tidsramme: 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
Tidsramme: 24 months post-randomization
|
24 months post-randomization
|
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Cost for treatment
Tidsramme: 3 months post-randomization
|
3 months post-randomization
|
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Cost for treatment
Tidsramme: 6 months post-randomization
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6 months post-randomization
|
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Cost for treatment
Tidsramme: 12 months post-randomization
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12 months post-randomization
|
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Cost for treatment
Tidsramme: 24 months post-randomization
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24 months post-randomization
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2015
Primær færdiggørelse (Forventet)
1. december 2019
Studieafslutning (Forventet)
1. december 2019
Datoer for studieregistrering
Først indsendt
11. januar 2016
Først indsendt, der opfyldte QC-kriterier
1. februar 2016
Først opslået (Skøn)
2. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014/1758-31/2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .