- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989518
The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Uppsala, Sweden
- Uppsala University, Departement of Psychology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin conductance response (SCR)
Time Frame: 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)
Time Frame: 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)
|
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Skin conductance response (SCR)
Time Frame: 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.
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Day 3 (48 h after day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear ratings
Time Frame: Day 1
|
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
Time Frame: Day 1
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 %
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Day 2 (24 h after day 1)
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Fear ratings
Time Frame: 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)
|
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Expectancy ratings
Time Frame: 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)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Task compliance
Time Frame: 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 %.
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Day 1
|
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Task compliance
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-00524
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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