Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
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Descrição detalhada
Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments most of the cases evolve with only partial remission, relapse and recurrence.
Cognitive models made a significant contribution in the understanding of unipolar depression and its psychological treatment. Even though, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence.
Our research group has been working in the notion of cognitive conflict viewed as personal dilemma according to personal construct theory. The investigators use a novel method for identifying those conflicts using the repertory grid technique. Preliminary results with depressive patients show that more than 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused in the resolution of these internal conflicts.
This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will contribute to enhance the efficacy of Cognitive-Behavioral Therapy for depression. A therapy manual for this approach will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: a CBT treatment package and another package combining cognitive-behavioral and dilemma-focused interventions. The investigators expect that this combined package will increase the efficacy of CBT, one of the more prestigious therapies for depression, this resulting in a significant contribution for its treatment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Barcelona
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Mataro, Barcelona, Espanha, 08304
- Hospital de Mataro (Consorci Sanitari del Maresme)
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Catalonia
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Barcelona, Catalonia, Espanha, 08004
- CAP Les Hortes
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Barcelona, Catalonia, Espanha, 08004
- Fundació Sanitària Sant Pere Claver
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Barcelona, Catalonia, Espanha, 08032
- Associació Catalana de Teràpies Cognitives
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Meeting diagnostic criteria for Major Depressive Disorder (MDD) or Dysthymic Disorder (DD) according to the DSM-IV-TR (APA, 2002) criteria a assessed using SCID-I
- A score above 19 on the BDI-II Questionnaire
- Presenting at leat one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the Repertory Grid Technique
- Enough level of competence to communicate in Spanish or Catalan
Exclusion Criteria:
- Bipolar disorders
- Psychotic symptoms
- Substance abuse
- Organic brain dysfunction
- Mental retardation
- Serious suicidal ideation
- Receiving psychological treatment (unless it is suspended at the time of inclusion in the study itself, in agreement with the patient and the practitioner applying it)
- Substantial visual, hearing or cognitive deficits
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Cognitive Behavioral + Dilemma Therapy
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
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7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session.
Manualized.
Outros nomes:
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Comparador Ativo: Cognitive Behavioral Therapy
Combined Group and Individual Cognitive Behavioral Therapy
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Cognitive Behavioral Therapy for Depression.
Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session.
Manualized.
Outros nomes:
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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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Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
Prazo: End of therapy (16 weeks), 3 and 12-month follow-up
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To assess change in severity of depressive symptoms.
The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.
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End of therapy (16 weeks), 3 and 12-month follow-up
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Hamilton-Depression Rating Scale-17 Items
Prazo: End of therapy and 12-month follow-up
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This clinician-administered measure was only applied to 78 patients at pre- and posttreatment.
It measures severity of depressive symptoms.
The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.
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End of therapy and 12-month follow-up
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Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
Prazo: End of therapy, 3 and 12 month follow-up
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To assess subjective well-being, symptoms or problems, life functioning, and risk.
The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34).
The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.
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End of therapy, 3 and 12 month follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Guillem Feixas, Ph.D., University of Barcelona
Publicações e links úteis
Publicações Gerais
- Feixas G, Bados A, Garcia-Grau E, Montesano A, Dada G, Compan V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saul-Gutierrez LA, Canete J, Gasol M, Ibarra M, Medeiros-Ferreira L, Soriano J, Ribeiro E, Caspar F, Winter D. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial. Trials. 2013 May 17;14:144. doi: 10.1186/1745-6215-14-144.
- Feixas G, Bados A, Garcia-Grau E, Paz C, Montesano A, Compan V, Salla M, Aguilera M, Trujillo A, Canete J, Medeiros-Ferreira L, Soriano J, Ibarra M, Medina JC, Ortiz E, Lana F. A DILEMMA-FOCUSED INTERVENTION FOR DEPRESSION: A MULTICENTER, RANDOMIZED CONTROLLED TRIAL WITH A 3-MONTH FOLLOW-UP. Depress Anxiety. 2016 Sep;33(9):862-9. doi: 10.1002/da.22510. Epub 2016 Apr 22.
- Feixas G, Paz C, Garcia-Grau E, Montesano A, Medina JC, Bados A, Trujillo A, Ortiz E, Compan V, Salla M, Aguilera M, Guasch V, Codina J, Winter DA. One-year follow-up of a randomized trial with a dilemma-focused intervention for depression: Exploring an alternative to problem-oriented strategies. PLoS One. 2018 Dec 13;13(12):e0208245. doi: 10.1371/journal.pone.0208245. eCollection 2018.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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 (Real)
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
- dilemma2012
- PSI2011-23246 (Número de outro subsídio/financiamento: Ministry of Science and Innovation (Spanish Government))
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