Dynamic Learning in Depression
15 de junho de 2020 atualizado por: University of Oxford
This study will assess learning bias (the tendency to learn more from negative relative to positive outcomes) at baseline in 3 groups of participants (currently depressed, previously depressed and never depressed).
It will then try to modify this bias using a simple computerised training task completed at home daily for 2 weeks.
Outcome measures include symptoms of depression, cognitive measures (i.e.
accuracy and reaction time during completion of tasks), pupillometry measures and salivary cortisol.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Depressed patients tend to focus on negative, at the expense of positive, events.
This bias of attention is thought to be one factor which causes some people to be at higher risk of developing depression.
One reason depressed people might pay more attention to negative events is that they think those events are more useful to them when they learn about the future.
In this study the investigators will compare the learning styles (i.e.
whether participants focus more on negative or positive information when learning about the future), cognitive biases and salivary cortisol levels (the levels of the hormone cortisol can be measured in the saliva and is known to be raised in those at risk of depression) of currently depressed (N=40), previously depressed (N=40) and never depressed (N=40) participants.
The study will then randomly assign participants to complete one of two version of a learning task daily over two weeks.
One version of the task will be designed to encourage an optimistic learning style, whereas the other will encourage neither an optimistic nor pessimistic learning style.
The study will then retest participants' learning styles, cognitive biases, salivary cortisol and mood (using questionnaire measures) after completion of the task and again after 1 month.
Study activities for participants will be: Screening visit (1 hours), baseline test visit (2 hours), task completion at home (10 mins per day for 2 weeks), test visit 2 (2 hours, completed 2 weeks after baseline visit) and test visit 3 (2 hours, completed 1 month after test visit 2).
Participants will be asked to collect saliva samples, to measure cortisol, immediately after they wake up on the 3 testing days.
Note that testing sessions involve pupillometry (measurement of area of pupil of the eye).
This is done using a specialised camera pointed at the eye and is not invasive.
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
-
-
Oxfordshire
-
Oxford, Oxfordshire, Reino Unido, OX3 7JX
- Dept of Psychiatry, University of Oxford
-
-
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 60 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 to 60 years.
- Fluent in English.
- Not currently taking any psychoactive medications (except hormone contraceptives).
- Currently meets SCID (Structured Clinical Interview for Diagnosis:DSMV) criteria for MDD--Major Depressive Disorder-- (currently depressed group only).
- Meets SCID criteria for 2 or more previous episodes of MDD, has been in remission for at least 3 months (previously depressed group only).
- No previous or current axis I diagnosis (control group only).
Exclusion Criteria:
- Previous or current diagnosis of bipolar disorder or psychotic illness.
- Previous or current anxiety disorder (control group only, anxiety disorder is permitted in current and previously depressed group as long as primary diagnosis of MDD (current or previous) is present).
- Significant suicidal ideation.
- Use of drug of abuse within the last 3 months.
- Receiving treatment (either pharmacological or psychological) for psychiatric condition.
- Medical or surgical treatment which prevents dilation/constriction of pupil.
- Prior experience of the tasks used in the study.
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: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: IBLT (information bias learning task)
Computerised task in which most information is provided by positive outcomes.
Completed for 10 mins per day every day for 2 weeks.
|
Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
|
|
Comparador de Placebo: IBLT control
Computerised task in which information is provided by both positive and negative outcomes.
Completed 10 mins per day every day for 2 weeks
|
A control version of the IBLT task-- a computer based task in which both positive and negative information is useful when learning how to complete it
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Prazo: change between baseline and week 6
|
Standard questionnaire measure of depressive symptoms
|
change between baseline and week 6
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Prazo: change between baseline and week 2
|
standard questionnaire measure of depressive symptoms
|
change between baseline and week 2
|
|
Montgomery Asberg Depression Rating Scale
Prazo: change from baseline to week 2 and 6
|
Standard clinical rating scale for depression
|
change from baseline to week 2 and 6
|
|
Learning parameters from information bias assessment task
Prazo: baseline to weeks 2 and 6
|
Derived parameters from a computer based learning task (tests process presumed to be altered by IBLT-- information bias learning task-- intervention)
|
baseline to weeks 2 and 6
|
|
Salivary cortisol concentration
Prazo: baseline to weeks 2 and 6
|
Samples collected on waking
|
baseline to weeks 2 and 6
|
|
Learning parameters derived from pupillometry data
Prazo: baseline to weeks 2 and 6
|
Parameters are derived from regression of pupil size data collected during the information bias assessment task
|
baseline to weeks 2 and 6
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Speilberger State and Trait Anxiety Inventory
Prazo: Baseline to weeks 2 and 6
|
standard questionnaire measure of state and trait anxiety
|
Baseline to weeks 2 and 6
|
|
Depressive Attributes Questionnaire
Prazo: baseline to weeks 2 and 6
|
Questionnaire assessing attribution bias in depression
|
baseline to weeks 2 and 6
|
|
Rumination Response Scale
Prazo: baseline to weeks 2 and 6
|
Questionnaire assessing tendency to ruminate
|
baseline to weeks 2 and 6
|
|
Snaith-Hamilton Pleasures Scale
Prazo: Baseline to weeks 2 and 6
|
Questionnaire assessing anhedonia
|
Baseline to weeks 2 and 6
|
|
Accuracy and reaction time during computerised cognitive tasks
Prazo: baseline to weeks 2 and 6
|
Scores are derived from computer based tasks assessing emotional perception and learning
|
baseline to weeks 2 and 6
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Michael Browning, MB.BS, University of Oxford
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)
1 de novembro de 2016
Conclusão Primária (Real)
3 de junho de 2020
Conclusão do estudo (Real)
3 de junho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
22 de setembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de setembro de 2016
Primeira postagem (Estimativa)
26 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de junho de 2020
Última verificação
1 de abril de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Dynamic Learning in Depression
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Anonymised data will be shared with researchers who contact the PI after study completion.
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 .