Cognitive Computer Training in Patients With Depression
29 de junho de 2016 atualizado por: Kjeld Andersen, University of Southern Denmark
Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression
Cognitive impairment plays an important role in functional recovery and leads to long-term sickness absence.
Therefore there is a need of a treatment specifically improving cognitive functions.
In this pilot study the investigators aim to evaluate the feasibility of using cognitive computer training in patients with unipolar depression to enhance cognitive performance.
Further the investigators investigate whether this intervention shortens sick leave.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
This study will evaluate cognitive computer training on patients in remission from depression by measuring the compliance and effect, investigating whether patients returned earlier to work and examine patients' physical and psychological health. This is done by comparing an intervention group and a control group.
Outpatients from psychiatric department Odense in Denmark will be recruited from December 2015 to July 2017.
At enrolment the participants wil be randomized 1:1 to either the intervention group or the control group. After the participants will complete a clinical interview and answer the The Short Form (36) Health Survey (SF-36) questionnaire. The participants' cognitive function and depression severity will be measured at baseline and three months follow-up. At nine months follow-up the participants will receive an email with the SF-36 questionnaire and questions about their education and work status, which they were required to answer.
The intervention is a cognitive computer program, consisting of different computer games. The intervention will start at enrolment and finish at the three months follow-up. The participants in the intervention group will do trainings session lasting 10-20 minutes three times a week. Each participant ends up with a total of 36 training sessions.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
20
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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Region of southern Denmark
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Odense C, Region of southern Denmark, Dinamarca, 5000
- Recrutamento
- Research Unit of Psychiatry, Psychiatric Unit Odense - University function
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Contato:
- Anja F Elliott, BACH.MED.
- Número de telefone: +4560795724
- E-mail: anjaelliott@hotmail.com
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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
20 anos a 63 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- a diagnosis of a moderate to severe unipolar depression according to the International Classification of Diseases -10 criteria
- receiving antidepressant medicine
- completed their treatment for depression
- not be in any risk of suicide
- study or work on reduced hours, be unemployed or on long-term sickness leave at enrolment.
Exclusion Criteria:
- neurological disease of the central nervous system
- alcohol or substance abuse
- pregnancy
- receiving disability pension
- receiving electroconvulsive therapy within the last 6 weeks.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
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COGNIFIT is cognitive computer training.
Its purpose is to improve cognitive function and is designed to accommodate each individual's cognitive strengths and weaknesses.
The cognitive computer training last three months and must be done three times a week, in session lasting 10-20 minutes.
Outros nomes:
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Sem intervenção: cogntrol group
The control group do not receive cognitive computer training for three months
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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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Employment status of the participants at nine months follow-up
Prazo: When the study is completed, approximately 15 months
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Questionnaire about employment status and will be send to the participants via email at nine months follow-up.
The questionnaire include questions according to: current working situation; why they are not working; when they started working; do they work at the same workplace; do they have the same work assignments as before they got ill; do whey work the same number of hour as before the got ill.
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When the study is completed, approximately 15 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Prazo: approximately nine months
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Concentration is measured by The Digit Span Test
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approximately nine months
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The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
Prazo: approximately nine months
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Attention is measured by The Letter Cancellation Test
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approximately nine months
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The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.
Prazo: approximately nine months
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Working memory is measured by The Letter Number Sequencing
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approximately nine months
|
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The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
Prazo: approximately nine months
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Learning is measured by the Rey Auditory Verbal Learning Test.
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approximately nine months
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The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Prazo: approximately nine months
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Executive function is measured by The Verbal Fluency
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approximately nine months
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The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.
Prazo: approximately nine months
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Psychomotor speed is measured by The Trial Making Test (TMT).
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approximately nine months
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The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Prazo: approximately nine months
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Executive function is measured by The Tower of London
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approximately nine months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Compliance of cognitive computer training
Prazo: approximately nine months
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The participants were supposed to do 36 sessions of cognitive computer training during three months.
The actual completed trainings sessions are available on the website of the cognitive computer training, called COGNIFIT.
The compliance is defined as the percentage of actual completed training sessions of the 36 sessions of training.
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approximately nine months
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The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.
Prazo: approximately 15 months
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The health status is measured by a patient-reported survey called the The Short Form (36) Health Survey (SF-36) questionnaire
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approximately 15 months
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The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.
Prazo: approximately nine months
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The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
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approximately nine months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Bent Nielsen, Prof.MD, University of Southern Denmark
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 dezembro de 2015
Conclusão Primária (Antecipado)
1 de outubro de 2017
Conclusão do estudo (Antecipado)
1 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
6 de junho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de junho de 2016
Primeira postagem (Estimativa)
4 de julho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de julho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de junho de 2016
Última verificação
1 de junho de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Cognex-depression
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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