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
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
-
-
-
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
No
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 |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: ICBT standard
Internet-based cognitive behavioural therapy with therapeutic guidance through mail
|
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
|
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
|
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
|
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
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.
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. .