Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

29 de maio de 2019 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

303

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Suécia
      • Stockholm, Suécia, 171 77
        • Karolinska Institutet

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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.
Comparador Ativo: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Karolinska Institutet

Colaboradores

Region Stockholm

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2015

Conclusão Primária (Antecipado)

1 de dezembro de 2019

Conclusão do estudo (Antecipado)

1 de dezembro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

11 de janeiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de fevereiro de 2016

Primeira postagem (Estimativa)

2 de fevereiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de maio de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2019

Última verificação

1 de maio de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2014/1758-31/2

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Transtornos por Uso de Álcool

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in South Africa

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

Se inscrever