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

Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial

13 de dezembro de 2019 atualizado por: Erik Hedman, Karolinska Institutet
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system. In this study psychologists will deliver the treatment. We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list. We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.

Tipo de estudo

Intervencional

Inscrição (Real)

100

Estágio

  • Não aplicável

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:

To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.

Exclusion Criteria:

Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.

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

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Active treatment, Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy. Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout.
Comportamental: Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy
Sem intervenção: Waiting list control
The control condition is a waiting list. Participants in this arm receive no active treatment. After 12 weeks on waiting list, participants are crossed over to treatment.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Perceived stress scale (PSS)
Prazo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in PSS at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Shirlom Melamed Burnout Questionnaire (SMBQ)
Prazo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in SMBQ at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Insomnia Severity Index (IS)
Prazo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in ISI at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Generalized AnxietyDisorder-7 (GAD-7)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in GAD-7 at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Physical Health Questionnaire-15 (PHQ-15)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in PHQ-15 at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in MADRS-S at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Self-rated health (SRH)
Prazo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in SRH at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Work Ability Index (WAI)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in WAI at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Euroqol 5 dimensions (EQ5D)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in EQ5D at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Brunnsviken Brief Quality of life inventory (BBQ)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in BBQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
World Health Organization Disability Assessment Schedule (WHODAS)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in WHODAS at post-treatment and follow-up compared to baseline.
baseline, post-treatment (12 weeks), 6 month follow-up
Alcohol Disorders Identification Test (AUDIT)
Prazo: Baseline
This instrument will be used for screening purpose only
Baseline
Sickness questionnaire state (SQ)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in SQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in TIC-P at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Karolinska Sleep Questionnaire (KSQ)
Prazo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in KSQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Client Satisfaction Questionnaire (CSQ)
Prazo: Post-treatment (12 weeks)
Mean and standard deviations will be presented
Post-treatment (12 weeks)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Credibility Scale (C-scale)
Prazo: Week 2 and week 8
Measures treatment credibility. Mean scores and standard deviations will be presented
Week 2 and week 8
Change in Putative mediators
Prazo: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Colaboradores e Investigadores

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

Patrocinador

Karolinska Institutet

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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 outubro de 2015

Conclusão Primária (Real)

1 de outubro de 2017

Conclusão do estudo (Real)

1 de outubro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

1 de setembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de setembro de 2015

Primeira postagem (Estimativa)

3 de setembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de dezembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de dezembro de 2019

Última verificação

1 de dezembro de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ICBT for stress

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 Síndrome de Burnout

Ensaios clínicos em Internet-based CBT

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Israel

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

Se inscrever