Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
8 de agosto de 2018 atualizado por: Gerhard Andersson, Linkoeping University
Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety: A Factorial Design
The purpose of this study is to evaluate the effects of learning support and chat on treatment outcome in internet-administrated cognitive behaviour therapy (ICBT) for adolescents with anxiety.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The study is set up as a factorial design with two independent variables: 1: Learning support and 2: chat-sessions in real time.
The intervention tested is based on cognitive behavior therapy delivered over the internet via a secure treatment platform.
Participants in the study are recruited from the general public via social media.
The intervention is in Swedish.
Tipo de estudo
Intervencional
Inscrição (Real)
120
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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Linköping, Suécia
- Linköping University
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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
15 anos a 19 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Be between the ages of 15-19 years old
- Have symptoms of anxiety, anxiety disorder
Exclusion Criteria:
- Suicidal ideation
- Alcohol addiction
- other major primary psychiatric disorder
- Ongoing psychological treatment
- recent (during last 4 weeks) change in psychiatric medication
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 fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: ICBT standard
Internet-based cognitive behavioural therapy with therapeutic guidance through mail
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Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
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Experimental: ICBT chat
Internet-based cognitive behavioural therapy with therapeutic guidance through chat
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Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
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Experimental: ICBT learning support
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail
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Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
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Experimental: ICBT with learning support and chat
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat
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Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Beck Anxiety Inventory (BAI)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures clinical anxiety.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Beck Depression Inventory - II (BDI-II)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures clinical depression.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Penn State Worry Questionnaire for Children (PSWQ - C)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures the tendency of youth to engage in excessive, generalized and uncontrollable worry.
Respondents rates each item on a 4-point Likert scale consisting of never (0), sometimes (1), often (2) and always (3).
The scores from each item are summed together to yield a total score that ranges from 0-42, with higher scores reflecting higher levels of worry.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Generalised Anxiety Disorder (GAD-7)
Prazo: First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.
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Measures severity of generalised anxiety.
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First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.
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Mini-Social Phobia Inventory (MINI-SPIN)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures clinical social phobia.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Agoraphobic Cognitions Questionnaire (ACQ)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures fearful cognitions associated with panic attacks and agoraphobia.
The ACQ consists of 14 items which will be scored as a total scale in this study.
worry.
Respondents rates each item on a 5-point Likert scale consisting of never (1), Thought never occurs (2), Thought rarely occurs (3) Thought occurs during half of the times when I am nervous (4) Thought usually occurs (5) Thought always occurs when I am nervous.
ACQ can be divided into two subscales: Loss of Control and Physical Concerns.
Each of the subscales consists of 7 items.The total scores (or the subscales) are calculated by averaging the responses to the individual items composing that score.
Higher scores indicates higher levels of fearful cognitions.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Satisfaction With Life Scale (SWLS)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures global cognitive judgements of one's life satisfacation as a whole, on a 5-item scale.
Respondants rates how much they agree or disagree on a 7-pont scale ranging from (7) strongly agree to (1) strongly disagree, where higher scores indicates higher levels of life satisfaction.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Rosenberg Self-Esteem Scale (RSES)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Evaluates individual self-esteem.
The scale is a ten item Likert scale with items answered on a four point scale, from (0) strongly agree to strongly disagree (3), where higher scores indicates higher self-esteem.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Alcohol Use Disorders Identification Test (AUDIT)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures alcohol consumption, drinking behaviors, and alcohol-related problems.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Knowledge of CBT strategies (developed by the research group)
Prazo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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A brief 16-item questionnaire that measures explicit, declarative knowledge about core CBT-principles and therapeutic points.
Higher scores indicates more knowledge.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Colaboradores e Investigadores
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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)
8 de fevereiro de 2018
Conclusão Primária (Real)
20 de maio de 2018
Conclusão do estudo (Real)
20 de junho de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
14 de fevereiro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de fevereiro de 2018
Primeira postagem (Real)
22 de fevereiro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de agosto de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de agosto de 2018
Última verificação
1 de agosto de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Dnr 2017/489-31.
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