- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03989518
The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Uppsala, Sverige
- Uppsala University, Departement of Psychology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Simple stimuli
Two perceptually simple stimuli are used during all experimental phases (geometrical figures).
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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.
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Eksperimentel: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Skin conductance response (SCR)
Tidsramme: Day 1
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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.
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Day 1
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Skin conductance response (SCR)
Tidsramme: Day 2 (24 h after day1)
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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.
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Day 2 (24 h after day1)
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Skin conductance response (SCR)
Tidsramme: Day 3 (48 h after day 1)
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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.
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Day 3 (48 h after day 1)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fear ratings
Tidsramme: Day 1
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 1
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State-Trait Anxiety Inventory
Tidsramme: Day 1
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This is a self-rated questionnaire measuring trait anxiety.
Higher scores indicate higher level of trait-anxiety (range 20-80)
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Day 1
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Difficulties in emotion regulation scale
Tidsramme: Day 1
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This is a self-rated questionnaire measuring difficulties in emotion regulation.
Higher scores indicate higher level of difficulties in emotion regulation (range 36-180)
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Day 1
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Fear ratings
Tidsramme: Day 2 (24 h after day 1)
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 2 (24 h after day 1)
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Vividness of mental imagery during imaginal extinction
Tidsramme: Day 2 (24 h after day 1)
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Scale: 1-5; no image at all - image as clear and vivid as real life
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Day 2 (24 h after day 1)
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The Plymouth Sensory Imagery Questionnaire
Tidsramme: Day 2 (24 h after day 1)
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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)
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Day 2 (24 h after day 1)
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The Vividness of Visual Imagery Questionnaire
Tidsramme: Day 2 (24 h after day 1)
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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)
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Day 2 (24 h after day 1)
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Spontaneous use of imagery scale
Tidsramme: Day 2 (24 h after day 1)
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This is a self-rated questionnaire measuring spontaneous use of imagery.
Higher scores higher levels use of spontaneous use of imagery (range 12- 60)
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Day 2 (24 h after day 1)
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Expectancy ratings
Tidsramme: Day 2 (24 h after day 1)
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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 %
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Day 2 (24 h after day 1)
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Fear ratings
Tidsramme: Day 3 (48 h after day 1)
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 3 (48 h after day 1)
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Expectancy ratings
Tidsramme: Day 3 (48 h after day 1)
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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 %
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Day 3 (48 h after day 1)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Task compliance
Tidsramme: Day 1
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 1
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Task compliance
Tidsramme: Day 2 (24 h after day 1)
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 2 (24 h after day 1)
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Task compliance
Tidsramme: Day 3 (48 h after day 1)
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 3 (48 h after day 1)
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2019-00524
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
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