Family Psychoeducation for Major Depressive Disorder
Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
More than 50 % of patients experiencing their first depressive episode will have at least one new episode. Therefore, effective interventions to reduce the risk of relapse are.
Psychoeducation is an interactive education form enhancing knowledge about patients' illness, including it course, symptoms and treatment.
Psychoeducational methods can also act as family intervention which already is an evidence-based practice in schizophrenia and bipolar disorder.
In spite of unipolar depression's high prevalence, only few studies have focused on the effect of psychoeducation, including family psychoeducation, in the prevention of new depressive episodes.
The aim of the present study is to compare an intervention consisting of Family Psychoeducation (FPE) to an active control intervention of social support for relatives of patients with a diagnosis of major depression.
The following hypotheses are proposed:
- Psychoeducational intervention for relatives will reduces the risk of depressive relapse (defined as a score on The Hamilton six-item subscale, HAM-D6≥7), among remitted depressed patients compared to the control condition
- Psychoeducational intervention for relatives will shorten time to achieve full symptomatic remission (defined as a score HAM-D6<5) among partially remitted depressed patients compared to the control condition
- Psychoeducational intervention for relatives will more effectively reduce depressive symptoms (measured on the HAM-D6) among patients fully symptomatic currently depressed patients, compared to control condition.
Secondary aims The study has as a secondary goal to investigate whether a high level of expressed emotion (EE) in relatives at baseline will be associated with poorer outcome, in the form of relapse, in depressed patients.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Hilleroed, Dinamarca, 3400
- Recrutamento
- Psychiatric Research Unit, Mental Health Centre North Zealand
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Contato:
- Nina Timmerby, MD
- Número de telefone: +4538643197
- E-mail: nina.02.timmerby@regionh.dk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Patients:
Inclusion Criteria:
- Age between 18 and 75
- Major depression diagnosis according to the ICD-10 established by a board certified psychiatrist and verified by the MINI International Neuropsychiatric Interview
- Living together , or in very regular contact (every day or almost every day), with an adult relative that the patient considers as emotionally important and who are available for intervention
Regarding hypothesis 1 and 2, patients will be included if they are in remission or partial remission at the inclusion time defined as a score <13 on the Hamilton Rating Scale for Depression (HAM-D17) [20]. Patients included for the test of hypothesis 3 have a HAM-D17-score >13 at the time of the inclusion.
Exclusion Criteria:
- Insufficient knowledge of Danish
- Clinical suspicion of dementia
- Alcohol, drug or medicine abuse
- Psychotic symptoms
- Co-morbidity of severe personality disorder
- Having undergone ECT treatment during the index depressive episode
- Maximum duration of the current depressive episode may not exceed 2 years
- Maximum duration of a period with stable remission may not exceed 3 consecutive months
Regarding to the relatives following criteria for participation apply:
Inclusion criteria:
• Age between 18 and 75
Exclusion criteria:
• Insufficient knowledge of Danish
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Family psychoeducation
The intervention consists of group-based family psychoeducation-program aimed at the patients' relatives.
Each group will consist of 5 participants and the patients will not be present at group sessions.
The program consists of four weekly sessions each consisting of both short lectures on relevant topics as well as interactive séances designed to give participants problem-solving skills.
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Comparador Ativo: Social support group
Relatives in the social support group will attend the same number of sessions of the same duration, as the relatives in the intervention group (family psychoeducation).
The psychiatric nurse who will be in charge of the social support group will not give any psychoeducational intervention.
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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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Number of relpase
Prazo: 9 months
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The primary outcome is relapse defined as a score ≥ 7 on HAM-D6 [47] in the 9-month follow-up period (hypothesis 1) among remitted patients.
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9 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Time to relapse
Prazo: Up to 9 months from baseline
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The number of weeks from baseline to relapse, time to full remission defined as a HAM-D6 <5, among the partially remitted patients (hypothesis 2)
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Up to 9 months from baseline
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Reduction of depressive symptoms
Prazo: 9 months
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Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3).
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9 months
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Nina Timmerby Timmerby, MD, Mental Health Centre North Zealand, Denmark
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H-4-2014-044
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