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The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction

31 de octubre de 2019 actualizado por: Uppsala University
Imaginal exposure is a widely used psychological treatment technique. Imaginal extinction is an experimental analogue of imaginal exposure, that allows the study of this treatment technique under controlled circumstances (Agren, Björkstrand, & Fredrikson, 2017). During imaginal extinction, experimentally induced fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. However, it is not known to what extent fear reduction depends on the mental imagery produced during this procedure. A better understanding of the mechanisms driving the effects of imaginal exposure and the factors moderating fear reduction could have significant clinical utility, by suggesting mechanistically informed ways to improve this treatment.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

60

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

      • Uppsala, Suecia
        • Uppsala University, Departement of Psychology

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:

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

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: 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

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Patrocinador

Publicaciones y enlaces útiles

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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)

25 de febrero de 2019

Finalización primaria (Actual)

30 de octubre de 2019

Finalización del estudio (Actual)

30 de octubre de 2019

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2019

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2019

Publicado por primera vez (Actual)

18 de junio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2019

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

31 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2019-00524

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Marco de tiempo para compartir IPD

Data will be available upon publication.

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.

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. .

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