- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05168592
The Neural Mechanisms of Imaginal Extinction
Exploring the Neural Mechanisms of Imaginal Extinction Using fMRI and Psychophysiology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, participants undergo threat conditioning to two pictures (CS+, CS-) in order to acquire a conditioned threat response. After this, the conditioned threat response is diminished through imaginal extinction (i.e extinction to the mental imagery of CS+ and CS-). Functional magnetic resonance imaging (7T) is used to measure neural activations during threat conditioning and imaginal extinction. Skin conductance is used to measure arousal response. Subjective fear and mental imagery vividness ratings will also be collected. In this way, this study aims to characterize the neural underpinnings of imaginal extinction.
Note that this study employs participants fearful of spiders. This is because data collection is shared with a related study (ClinicalTrials.gov ID 2020-06930a).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Ågren, PhD
- Phone Number: +46(0)184712124
- Email: thomas.agren@psyk.uu.se
Study Contact Backup
- Name: Johannes Björkstrand, PhD
- Email: johannes.bjorkstrand@psy.lu.se
Study Locations
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Lund, Sweden, 22242
- Recruiting
- The Swedish 7T facility
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Contact:
- Karin Markenroth Bloch, PhD
- Email: karin.markenroth@med.lu.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Willing and able to provide informed consent and complete study procedures
- Fear of spiders (due to data collection together with ID 2020-06930a)
Exclusion Criteria:
- Current psychiatric disorder other than spider phobia. Current use of psychotropic medication. Current neurological conditions. MRI-contraindications (i.e metal implants in skull).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaginal extinction
Conditioned fear will be diminished using imaginal extinction.
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Day 1: The participant is repeatedly shown two stimulus (CS+,CS-), one at a time.
CS+ is paired with an electric shock.
CS- acts as a control stimulus.
The stimuli consist of photos of two different objects.
Stimuli will be counterbalanced between participants.
Day 1: Participants are repeatedly instructed to produce mental imagery of the two stimuli used during threat conditioning.
Imagery is prompted through different written instructions presented in pseudo-randomized order on a screen.
No shocks will be delivered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood oxygen level dependent contrast (BOLD-signal) during threat conditioning and imaginal extinction.
Time Frame: Day 1
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BOLD-signal is assessed using functional magnetic resonance imaging.
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Day 1
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Physiological arousal response during threat conditioning and imaginal extinction.
Time Frame: Day 1
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Skin conductance responses are used as a measure of physiological arousal response (i.e.
event-related rise in electrodermal activity to stimuli).
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Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Task-specific mental imagery vividness during imaginal extinction
Time Frame: Day 1
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Vividness of Imagery (scale:1-5; no image at all - image as clear and vivid as real life)
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Day 1
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Ratings of subjective fear experienced during threat conditioning and imaginal extinction.
Time Frame: Day 1
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Scale 0-100; no fear at all - extreme fear
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Day 1
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Spielberger State-Trait Anxiety Inventory (STAI-T)
Time Frame: One week after Day 1
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STAI-T is a self-rated questionnaire included assess trait-anxiety in the participants.
Scale: 20-80, where higher scores represent higher levels of trait anxiety.
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One week after Day 1
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Vividness of visual imagery Questionnaire (VVIQ)
Time Frame: One week after Day 1
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VVIQ is used to measure individual differences in the Vividness of Visual mental Imagery; scale: 16-80 where higher scores represent a higher ability for visual imagery.
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One week after Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thoma Ågren, PhD, Uppsala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 2020-06930b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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