Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
8 de setembro de 2022 atualizado por: University of Minnesota
Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring anxiety disorder ("comorbidity"), a condition that marks a high degree of treatment resistance, severity and relapse risk in AUD treatment patients.
The investigators conceptualize comorbidity as a feed-forward system ("vicious cycle", [VC]) of interacting negative affect/stress, drinking motives/behavior, coping skills deficits, environmental circumstances, and neurobiological adaptations.
Based on this model, the investigators developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system at several key linkage points.
In a recently completed randomized controlled trial (RCT), the investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or standard AUD treatment alone.
With a number needed to treat (NNT) index of 8 (relative to standard AUD treatment alone), the VC-CBT could, if broadly disseminated, have a large positive impact on AUD treatment.
Unfortunately, several significant barriers related to the resource- and expertise-intensive delivery of the VC-CBT limit its dissemination potential and, hence, the impact of this otherwise effective treatment.
Therefore, to maximize the public health and scientific potential of the investigators work, the investigators propose to adapt the therapist-delivered VC-CBT to a computer-delivered format to facilitate reliable and economical dissemination of the VC-CBT while maintaining its established efficacy.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The first phase of the work (Year 1) will be to adapt the 6-session therapist-delivered VC-CBT for delivery on an internet-based computer platform.
This work will be done using a standard iterative process for developing e-content in partnership with local technology experts experienced in producing engaging and effective e-learning products.
Approximately 5 patients will be employed in this phase.
The second phase (Years 2 and 3) will be devoted to a single arm pilot trial to test the efficacy of the refined computer-delivered VC-CBT.
The investigators will recruit AUD treatment patients with co-occurring anxiety disorder to receive the computer-delivered VC-CBT (50 patients).
Participants will complete follow-up assessments one and four months following treatment.
Participants will rate user satisfaction and will be evaluated on skill and knowledge acquisition as well as use of the tools in the follow-up period.
Success in the proposed work will serve as pilot data in support of a rigorous randomized clinical trial.
The proposed work aims to provide an easy and inexpensive computer-delivered version of the VC-CBT that has comparable efficacy to the validated but resource-intensive therapist-delivered version.
Achieving this will enable the VC-CBT therapy to benefit more AUD treatment patients and to be more easily studied by other investigators.
Tipo de estudo
Intervencional
Inscrição (Real)
59
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
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55408
- University of Minnesota
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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 a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Diagnostic and Statistical Manual-IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
- Diagnostic and Statistical Manual-IV diagnosis of alcohol dependence within the last 30 days
- inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
- alcohol use in the 30 days preceding the beginning of their Lodging Plus (LP) treatment
- willingness and ability to provide informed consent
- minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form
- familiarity with computer keyboarding as determined by history
- lives within reasonable driving distance of the Twin Cities and ability to travel to Fairview to allow for in-person follow-up interviews
Exclusion Criteria:
- Active psychosis or mania in the three months preceding the study
- Physical impairment (e.g., blindness, deafness) that interferes with study participation based on self-report or as judged by PI or study physician
- current significant suicide risk (i.e., intention and plan) as deemed by the PI and study physician to be serious and ongoing
- primary PTSD as determined by the Structured Clinical Interview for DSM (SCID) interview
- suspected cognitive impairment that interferes with study participation as informed by the SCID interview or as judged by the PI or study physician
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Computer-based VC-CBT
Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
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Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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User ratings
Prazo: up to 4 days post-treatment
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Likert scale ratings of understanding, engagement, and applicability to current problems
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up to 4 days post-treatment
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Knowledge Acquisition
Prazo: up to 4 days post-treatment
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Multiple choice and True/False questions to assess knowledge communicated in program
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up to 4 days post-treatment
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Skills Acquisition
Prazo: up to 4 days post-treatment
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Skill demonstration rated by study staff for accuracy
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up to 4 days post-treatment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 (Real)
16 de abril de 2018
Conclusão Primária (Real)
26 de abril de 2021
Conclusão do estudo (Real)
26 de julho de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
3 de agosto de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de setembro de 2017
Primeira postagem (Real)
3 de outubro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de setembro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de setembro de 2022
Última verificação
1 de setembro de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PSYCH-2018-26640
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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