Priming Attachment Security Within an IAPT Setting
13 de julho de 2019 atualizado por: Charlotte Heathcote, University of Sheffield
Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study
There is growing evidence that priming attachment security is associated with improved attitudes towards therapy, increased engagement and decreased levels of depression and anxiety.
Within the Improving Access to Psychological Therapies (IAPT) programme a consistent problem has been identified of high dropout rates at step 2 services (i.e.
where mild to moderate anxious and depressed patients receive guided self-help interventions).
The current study incorporates a feasibility and pilot design.
The feasibility element will explore issues related to study design to determine suitability for conducting a future randomised control trial (RCT).
The pilot study will look at the processes outlined in the protocol to determine whether the study components all work together.
Moreover, it will preliminarily aim to explore the effectiveness of the attachment security priming intervention on symptoms of depression and anxiety, as well as impaired functioning.
Both elements of the study will determine whether any changes are needed to the study design or protocol, and whether a future RCT is suitable and necessary.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
The study is being conducted in an IAPT primary care service in North Yorkshire.
The study will be recruiting 50 participants experiencing mild to moderate depression who are deemed suitable for 'behavioural activation' low intensity guided self-help intervention.
Following telephone screening for intervention, clinicians will ask clients if they wish to hear more about participating in a research study.
If participants say yes, their contact details will be passed on to the researcher who will send them the study information sheet and consent form in the post.
If the participant consents to taking part in the research, they will be randomised to receive either treatment as usual (low-intensity guided self-help utilising behavioural activation for depression) or treatment with security priming intervention (treatment as usual with an additional security priming task).
They will have between 6-8 sessions as routinely delivered within the service and will be asked to complete measures of depression, anxiety and impaired functioning on a sessional basis.
The principal investigator at the study site will collect information regarding attendance to therapy, dropout rates, and 'stepping' clients up to higher-intensity therapies as primary outcomes.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
50
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
-
-
North Yorkshire
-
Harrogate, North Yorkshire, Reino Unido, hg12pw
- Harrogate IAPT Service
-
-
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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Over age 18.
- Adequate English ability.
Exclusion Criteria:
- Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Inadequate English ability.
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 |
|---|---|
|
Comparador Ativo: Treatment as Usual
Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service.
|
Clients will engage in treatment as usual.
This involves low-intensity guided self-help behavioural activation for depression.
|
|
Experimental: Treatment with Security Prime
Participants randomised to the experimental group will receive behavioural activation guided self-help intervention as is routinely delivered in the service with additional attachment security priming intervention.
|
In addition to their treatment as usual (low-intensity guided self-help behavioural activation for depression), participants will complete an initial attachment security priming task during the first session with their allocated clinician. Participants will be prompted in their intervention workbook with a caption regarding what a secure attachment relationship represents. They will be asked to think of a person/ people with whom they feel they have this relationship, and list them. Following this, they are asked to plot these individuals on a diagram of concentric circles in relation to how close they feel this person is to them. The closer to the middle of the diagram the individual places each person, the closer they feel their relationship to that person is. Prior to each session with their clinician, they will be prompted to complete a repeated security priming task in order to increase feelings of security prior to therapy sessions. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Attendance
Prazo: Up to 8 weeks from the beginning to end of treatment
|
Number of therapy appointments booked versus number attended for each participant
|
Up to 8 weeks from the beginning to end of treatment
|
|
Dropout
Prazo: Up to 8 weeks from the beginning to end of treatment
|
Number of participants who drop out of therapy after attending at least one session of treatment
|
Up to 8 weeks from the beginning to end of treatment
|
|
Stepping-up to higher intensity services
Prazo: Up to 8 weeks from the beginning to end of treatment
|
The number of participants in the study who are referred for a higher intensity form of therapy during their low-intensity therapy
|
Up to 8 weeks from the beginning to end of treatment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Prazo: Weekly for up to 8 weeks from the beginning to end of treatment
|
Self-report measure of depression with total possible score ranging from 0 to 27.
Scores of 0-4 indicate minimal depression; 5-9 indicates mild depression; 10-14 indicates moderate depression; 15-19 indicates moderately severe depression; and 20-17 indicates severe depression.
|
Weekly for up to 8 weeks from the beginning to end of treatment
|
|
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)
Prazo: Weekly for up to 8 weeks from the beginning to end of treatment
|
Self-report measure of anxiety with total possible scores between 0 to 21. Scores of 0-5 indicate mild anxiety; 6-10 indicates moderate anxiety; 11-15 indicates moderately severe anxiety; and 16-20 indicates severe anxiety.
|
Weekly for up to 8 weeks from the beginning to end of treatment
|
|
The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)
Prazo: Weekly for up to 8 weeks from the beginning to end of treatment
|
Self-report measure of impaired functioning with total possible scores of between 0-20.
Scores below 10 are associated with subclinical populations.
Scores between 10 and 20 indicate significant functional impairment but less severe clinical symptomatology.
Scores above 20 indicate moderately severe or worse psychopathology.
|
Weekly for up to 8 weeks from the beginning to end of treatment
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: James Walton, Harrogate IAPT Service
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 (Antecipado)
1 de agosto de 2019
Conclusão Primária (Antecipado)
1 de outubro de 2019
Conclusão do estudo (Antecipado)
1 de outubro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
17 de junho de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de julho de 2019
Primeira postagem (Real)
17 de julho de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de julho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de julho de 2019
Última verificação
1 de julho de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 249633
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .