- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03989518
The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study takes part over three consecutive days, with fear conditioning to visual stimuli on day 1, imaginal extinction on day 2, and a fear reinstatement procedure, again to visual stimuli, on day 3. Skin conductance is used to measure fear responses.
Participants' are randomized to receive conditioning, extinction and reinstatement with either complex or simple stimuli. During imaginal extinction, imagery of each experimental stimulus is prompted through different verbal instructions.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Uppsala, Suecia
- Uppsala University, Departement of Psychology
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Age 18 or over
Fluent in Swedish
Willing and able to provide informed consent and complete study procedures
Exclusion Criteria:
Current psychiatric disorder
Use of psychotropic medication within 6 months prior to study start
Receiving psychological treatment within 6 months prior to study start
Current neurological condition
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Simple stimuli
Two perceptually simple stimuli are used during all experimental phases (geometrical figures).
|
Day 1. Participants are exposed to two different visual stimuli.
One of these stimuli is paired with a mild electric shock (i.e.
conditioned stimuli).
Day 2 (24 hours after Day 1).
Participants are exposed to mental imagery of the stimuli used during fear conditioning.
Imagery is prompted through different verbal instructions presented in a pseudo-randomized order.
No shocks are delivered.
Prior to imaginal extinction, participants receive task specific training.
Day 3 (48 h after day1).
Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2).
Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus.
No further shocks are delivered.
This procedure allows the study of long term effects of imaginal extinction.
|
|
Experimental: Complex stimuli
Two complex stimuli are used in all experimental phases.
Stimuli consist of photographs of real objects of the same size and shape as the simple stimuli, but include perceptually more complex patterns, details and colors.
|
Day 1. Participants are exposed to two different visual stimuli.
One of these stimuli is paired with a mild electric shock (i.e.
conditioned stimuli).
Day 2 (24 hours after Day 1).
Participants are exposed to mental imagery of the stimuli used during fear conditioning.
Imagery is prompted through different verbal instructions presented in a pseudo-randomized order.
No shocks are delivered.
Prior to imaginal extinction, participants receive task specific training.
Day 3 (48 h after day1).
Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2).
Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus.
No further shocks are delivered.
This procedure allows the study of long term effects of imaginal extinction.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Skin conductance response (SCR)
Periodo de tiempo: Day 1
|
SCR is used as a measure of physiological fear responses.
Differences in fear responses are used to assess fear learning during fear acquisition and to explore main effects and interactions between fear learning, stimulus complexity and capacity for mental imagery.
|
Day 1
|
|
Skin conductance response (SCR)
Periodo de tiempo: Day 2 (24 h after day1)
|
SCR is used as a measure of physiological fear responses.Differences in fear responses are used to assess fear reduction during imaginal extinction, and to explore main effects and interactions between fear reduction, stimulus complexity and capacity for mental imagery.
|
Day 2 (24 h after day1)
|
|
Skin conductance response (SCR)
Periodo de tiempo: Day 3 (48 h after day 1)
|
SCR is used as a measure of physiological fear responses.Differences in fear response are used to assess return of fear during reinstatement, and to explore main effects and interactions between return of fear, stimulus complexity and capacity for mental imagery.
|
Day 3 (48 h after day 1)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fear ratings
Periodo de tiempo: Day 1
|
Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
|
Day 1
|
|
State-Trait Anxiety Inventory
Periodo de tiempo: Day 1
|
This is a self-rated questionnaire measuring trait anxiety.
Higher scores indicate higher level of trait-anxiety (range 20-80)
|
Day 1
|
|
Difficulties in emotion regulation scale
Periodo de tiempo: Day 1
|
This is a self-rated questionnaire measuring difficulties in emotion regulation.
Higher scores indicate higher level of difficulties in emotion regulation (range 36-180)
|
Day 1
|
|
Fear ratings
Periodo de tiempo: Day 2 (24 h after day 1)
|
Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
|
Day 2 (24 h after day 1)
|
|
Vividness of mental imagery during imaginal extinction
Periodo de tiempo: Day 2 (24 h after day 1)
|
Scale: 1-5; no image at all - image as clear and vivid as real life
|
Day 2 (24 h after day 1)
|
|
The Plymouth Sensory Imagery Questionnaire
Periodo de tiempo: Day 2 (24 h after day 1)
|
This is a self-rated questionnaire measuring vividness of mental imagery across different sensory modalities.
Higher scores indicate higher level of vividness.
(range 0-70)
|
Day 2 (24 h after day 1)
|
|
The Vividness of Visual Imagery Questionnaire
Periodo de tiempo: Day 2 (24 h after day 1)
|
This is a self-rated questionnaire measuring vividness of visual mental imagery.
Only eyes open section is administered.
Higher scores indicate higher level of vividness (range 0-80)
|
Day 2 (24 h after day 1)
|
|
Spontaneous use of imagery scale
Periodo de tiempo: Day 2 (24 h after day 1)
|
This is a self-rated questionnaire measuring spontaneous use of imagery.
Higher scores higher levels use of spontaneous use of imagery (range 12- 60)
|
Day 2 (24 h after day 1)
|
|
Expectancy ratings
Periodo de tiempo: Day 2 (24 h after day 1)
|
After the imaginal extinction procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 %
|
Day 2 (24 h after day 1)
|
|
Fear ratings
Periodo de tiempo: Day 3 (48 h after day 1)
|
Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
|
Day 3 (48 h after day 1)
|
|
Expectancy ratings
Periodo de tiempo: Day 3 (48 h after day 1)
|
After the reinstatement procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 %
|
Day 3 (48 h after day 1)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Task compliance
Periodo de tiempo: Day 1
|
Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
|
Day 1
|
|
Task compliance
Periodo de tiempo: Day 2 (24 h after day 1)
|
Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
|
Day 2 (24 h after day 1)
|
|
Task compliance
Periodo de tiempo: Day 3 (48 h after day 1)
|
Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
|
Day 3 (48 h after day 1)
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2019-00524
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
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. .