Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
29. mai 2019 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
303
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Stockholm, Sverige, 171 77
- Karolinska Institutet
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
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
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6 months post-randomization
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Alcohol Use Disorders Identification Test score
Tidsramme: 12 months post-randomization
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12 months post-randomization
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Alcohol Use Disorders Identification Test score
Tidsramme: 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
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
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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
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
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24 months post-randomization
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Number of days absent from work due to illness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months post-randomization
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24 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
Tidsramme: 3 months post-randomization
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3 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
Tidsramme: 6 months post-randomization
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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
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24 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
Tidsramme: 3 months post-randomization
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3 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
Tidsramme: 6 months post-randomization
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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
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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
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24 months post-randomization
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Cost for treatment
Tidsramme: 3 months post-randomization
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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
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2015
Primær fullføring (Forventet)
1. desember 2019
Studiet fullført (Forventet)
1. desember 2019
Datoer for studieregistrering
Først innsendt
11. januar 2016
Først innsendt som oppfylte QC-kriteriene
1. februar 2016
Først lagt ut (Anslag)
2. februar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mai 2019
Sist bekreftet
1. mai 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2014/1758-31/2
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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