Priming Attachment Security Within an IAPT Setting
13 de julio de 2019 actualizado 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Anticipado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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North Yorkshire
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Harrogate, North Yorkshire, Reino Unido, hg12pw
- Harrogate IAPT Service
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
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Clients will engage in treatment as usual.
This involves low-intensity guided self-help behavioural activation for depression.
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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.
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Attendance
Periodo de tiempo: Up to 8 weeks from the beginning to end of treatment
|
Number of therapy appointments booked versus number attended for each participant
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Up to 8 weeks from the beginning to end of treatment
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Dropout
Periodo de tiempo: Up to 8 weeks from the beginning to end of treatment
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Number of participants who drop out of therapy after attending at least one session of treatment
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Up to 8 weeks from the beginning to end of treatment
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Stepping-up to higher intensity services
Periodo de tiempo: Up to 8 weeks from the beginning to end of treatment
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The number of participants in the study who are referred for a higher intensity form of therapy during their low-intensity therapy
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Up to 8 weeks from the beginning to end of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Periodo de tiempo: 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.
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Weekly for up to 8 weeks from the beginning to end of treatment
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The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)
Periodo de tiempo: Weekly for up to 8 weeks from the beginning to end of treatment
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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.
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Weekly for up to 8 weeks from the beginning to end of treatment
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The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)
Periodo de tiempo: Weekly for up to 8 weeks from the beginning to end of treatment
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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.
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Weekly for up to 8 weeks from the beginning to end of treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: James Walton, Harrogate IAPT Service
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de agosto de 2019
Finalización primaria (Anticipado)
1 de octubre de 2019
Finalización del estudio (Anticipado)
1 de octubre de 2019
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2019
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2019
Publicado por primera vez (Actual)
17 de julio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 249633
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Treatment as Usual (Behavioural Activation)
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Training and Implementation AssociatesReclutamientoEntrenamiento Tradicional Presencial | Plataforma de Capacitación e Implementación de Terapia Familiar (FTTIP)Estados Unidos