- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05193383
Neural Mechanisms of Imaginal and in Vivo Exposure
Neural Mechanisms of Imaginal and in Vivo Exposure: Exploring the Differences Between Imaginal and in Vivo Exposure, Using fMRI and Psychophysiology
Study Overview
Status
Conditions
Detailed Description
The study includes participants fearful of spiders and entails two experimental sessions, roughly one week apart. The first session includes brain imaging using functional magnetic resonance imaging (fMRI). During the first session, participants will be randomized into one of two conditions - in vivo exposure or imaginal exposure. In the in vivo exposure condition, participants will be shown video clips of spiders (fearful stimuli) and leaves (neutral stimuli) in different situations. In the imaginal exposure condition, participants will be instructed to produce mental imagery of the corresponding stimuli used for in vivo exposure.
Previous research found that the brief exposure procedure used during session 1 produced a fear reduction when the procedure was repeated one week later. Thus, in order to conceptually replicate this finding, and to examine the generalizability of fear reduction, participants return roughly one week later for a follow-up session. In the follow-up session, participants undergo a similar exposure procedure as used in session 1, but with half of the stimuli in vivo and the other half of the stimuli as mental imagery. In this way, it can be studied whether fear reduction generalize from exposure modality to another. The effects of imaginal and in vivo exposure on avoidance behavior towards fear-provoking stimuli (spiders) will also be assessed using an approach-avoidance conflict paradigm, using pictures of spiders to probe spider fear.
The current study will also explore the impact of mental imagery vividness during imaginal exposure on fear reduction. Additionally, the study will assess if vividness level can predict the generalizability of the effects of imaginal exposure to fear-provoking stimuli (mental imagery of a spider) on subsequent fear responses to to in vivo stimuli (film clip of a spider) one week later.
Functional magnetic resonance imaging (7T) is used to measure neural activations (session 1). Skin conductance is used to measure arousal response (session 1 & 2). Subjective fear and mental imagery vividness ratings will also be collected.
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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaginal exposure
Exposure to mental imagery including a fearful stimulus (spider) and corresponding scenes including a neutral stimulus (leaf)
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Session 1 (Day 1): Participants receive repeated exposure to mental imagery of fear-provoking stimuli (spiders) and neutral stimuli (leaves) while undergoing brain imaging med fMRI.
Session 2 (Ca one week): Participants receive both imaginal and in vivo exposure to fear-provoking stimuli and neutral stimuli (both arms are exposed to both video clips (in vivo exposure) and mental imagery (imaginal exposure).
Session 2 is conducted in the laboratory, i.e., no brain imaging.
Session 2 (Ca one week): Spider fear is probed by an approach-avoidance conflict task.
Participants can receive varying small rewards for watching pictures of spiders, or avoid the spider pictures at the cost of not receiving a reward (neutral pictures are shown instead).
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Experimental: In vivo exposure
Exposure to video clips including a fearful stimulus (spider) and corresponding clips including a neutral stimulus (leaf)
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Session 2 (Ca one week): Participants receive both imaginal and in vivo exposure to fear-provoking stimuli and neutral stimuli (both arms are exposed to both video clips (in vivo exposure) and mental imagery (imaginal exposure).
Session 2 is conducted in the laboratory, i.e., no brain imaging.
Session 2 (Ca one week): Spider fear is probed by an approach-avoidance conflict task.
Participants can receive varying small rewards for watching pictures of spiders, or avoid the spider pictures at the cost of not receiving a reward (neutral pictures are shown instead).
Session 1 (Day 1): in vivo exposure.
Participants receive repeated exposure to film clips of fear-provoking stimuli (spiders) and neutral stimuli (leaves) while undergoing brain imaging med fMRI.
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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 exposure to fearful stimuli (in vivo or imaginal).
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 exposure (in vivo or imaginal).
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 as a response to stimulus.
Unit of measure is microSiemens.
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Day 1
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Physiological arousal response during follow-up exposure
Time Frame: One week after 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 as a response to stimulus.
Unit of measure is microSiemens.
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One week after Day 1
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Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli
Time Frame: Day1
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Scale 0-100; no fear at all - extreme fear
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Day1
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Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli
Time Frame: One week after Day 1
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Scale 0-100; no fear at all - extreme fear
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One week after Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratings of subjective fear participants expect to experience during exposure to fearful stimuli
Time Frame: Day 1 & one week after Day 1
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Scale 0-100; no fear at all - extreme fear
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Day 1 & one week after Day 1
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Number of approach-avoidance decisions during an approach-avoidance behaviour task using fearful stimuli (spiders)
Time Frame: One week after Day 1
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Number of participants' decisions to avoid looking at a fearful stimuli, or to look at them and be compensated with at small amount.
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One week after Day 1
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Task-specific mental imagery vividness ratings to fearful and neutral stimuli during imaginal exposure, and follow-up exposure (not applicable during in vivo exposure).
Time Frame: Day 1 & one week after 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 & one week after 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 which assess trait anxiety.
Scale: 20-80 in the participants 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 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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Amount of watching film clips (not applicable during imaginal exposure).
Time Frame: Day 1 & one week after Day 1
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Assessment of avoidance when watching film clips.
"To what extent did you watch the film clips (i.e.
not close your eyes)?"
Scale 0-100% of film clips.
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Day 1 & one week after Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Ågren, PhD, Uppsala University
Publications and helpful links
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
Keywords
Other Study ID Numbers
- 2020-06930a
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
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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