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

29 maggio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

303

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svezia
      • Stockholm, Svezia, 171 77
        • Karolinska Institutet

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Lasso di tempo: 3 months post-randomization
3 months post-randomization

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Karolinska Institutet

Collaboratori

Region Stockholm

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2015

Completamento primario (Anticipato)

1 dicembre 2019

Completamento dello studio (Anticipato)

1 dicembre 2019

Date di iscrizione allo studio

Primo inviato

11 gennaio 2016

Primo inviato che soddisfa i criteri di controllo qualità

1 febbraio 2016

Primo Inserito (Stima)

2 febbraio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2019

Ultimo verificato

1 maggio 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2014/1758-31/2

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

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