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Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

8 de agosto de 2018 actualizado por: Gerhard Andersson, Linkoeping University

Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety: A Factorial Design

The purpose of this study is to evaluate the effects of learning support and chat on treatment outcome in internet-administrated cognitive behaviour therapy (ICBT) for adolescents with anxiety.

Descripción general del estudio

Estado

Terminado

Condiciones

Ansiedad

Intervención / Tratamiento

Descripción detallada

The study is set up as a factorial design with two independent variables: 1: Learning support and 2: chat-sessions in real time. The intervention tested is based on cognitive behavior therapy delivered over the internet via a secure treatment platform. Participants in the study are recruited from the general public via social media. The intervention is in Swedish.

Tipo de estudio

Intervencionista

Inscripción (Actual)

120

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

Suecia
- - Linköping, Suecia
    - Linköping University

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

15 años a 19 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Be between the ages of 15-19 years old
Have symptoms of anxiety, anxiety disorder

Exclusion Criteria:

Suicidal ideation
Alcohol addiction
other major primary psychiatric disorder
Ongoing psychological treatment
recent (during last 4 weeks) change in psychiatric medication

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 factorial
Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo Grupo de participantes/brazo Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.	Intervención / Tratamiento Intervención / Tratamiento Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Comparador activo: ICBT standard Internet-based cognitive behavioural therapy with therapeutic guidance through mail	Conductual: Guided-ICBT for adolescents with anxiety Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
Experimental: ICBT chat Internet-based cognitive behavioural therapy with therapeutic guidance through chat	Conductual: Guided-ICBT with chat Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
Experimental: ICBT learning support Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail	Conductual: Guided-ICBT with learning support Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
Experimental: ICBT with learning support and chat Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat	Conductual: Guided-ICBT with learning support and chat Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Beck Anxiety Inventory (BAI) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Measures clinical anxiety. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Beck Depression Inventory - II (BDI-II) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Measures clinical depression. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Penn State Worry Questionnaire for Children (PSWQ - C) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Measures the tendency of youth to engage in excessive, generalized and uncontrollable worry. Respondents rates each item on a 4-point Likert scale consisting of never (0), sometimes (1), often (2) and always (3). The scores from each item are summed together to yield a total score that ranges from 0-42, with higher scores reflecting higher levels of worry. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Generalised Anxiety Disorder (GAD-7) Periodo de tiempo: First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.	Measures severity of generalised anxiety.	First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.
Mini-Social Phobia Inventory (MINI-SPIN) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Measures clinical social phobia. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Agoraphobic Cognitions Questionnaire (ACQ) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Measures fearful cognitions associated with panic attacks and agoraphobia. The ACQ consists of 14 items which will be scored as a total scale in this study. worry. Respondents rates each item on a 5-point Likert scale consisting of never (1), Thought never occurs (2), Thought rarely occurs (3) Thought occurs during half of the times when I am nervous (4) Thought usually occurs (5) Thought always occurs when I am nervous. ACQ can be divided into two subscales: Loss of Control and Physical Concerns. Each of the subscales consists of 7 items.The total scores (or the subscales) are calculated by averaging the responses to the individual items composing that score. Higher scores indicates higher levels of fearful cognitions. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Satisfaction With Life Scale (SWLS) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Measures global cognitive judgements of one's life satisfacation as a whole, on a 5-item scale. Respondants rates how much they agree or disagree on a 7-pont scale ranging from (7) strongly agree to (1) strongly disagree, where higher scores indicates higher levels of life satisfaction. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Rosenberg Self-Esteem Scale (RSES) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Evaluates individual self-esteem. The scale is a ten item Likert scale with items answered on a four point scale, from (0) strongly agree to strongly disagree (3), where higher scores indicates higher self-esteem. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Alcohol Use Disorders Identification Test (AUDIT) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	Measures alcohol consumption, drinking behaviors, and alcohol-related problems. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Knowledge of CBT strategies (developed by the research group) Periodo de tiempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment	A brief 16-item questionnaire that measures explicit, declarative knowledge about core CBT-principles and therapeutic points. Higher scores indicates more knowledge. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Linkoeping University

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 (Actual)

8 de febrero de 2018

Finalización primaria (Actual)

20 de mayo de 2018

Finalización del estudio (Actual)

20 de junio de 2018

Fechas de registro del estudio

Enviado por primera vez

14 de febrero de 2018

Primero enviado que cumplió con los criterios de control de calidad

20 de febrero de 2018

Publicado por primera vez (Actual)

22 de febrero de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de agosto de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

8 de agosto de 2018

Última verificación

1 de agosto de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Dnr 2017/489-31.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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. .

Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety