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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05193383
Other study ID # 2020-06930a
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 7, 2022
Est. completion date December 2022

Study information

Verified date April 2022
Source Uppsala University
Contact Thomas Ågren, PhD
Phone +46(0)184712124
Email thomas.agren@psyk.uu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Imaginal exposure is a widely used and effective psychological treatment technique. Recent research suggests that neural activations and emotional responses during imaginal exposure are similar to those elicited during in vivo exposure. However, to the investigators knowledge, no direct comparison between in vivo and imaginal exposure has been performed during neuroimaging. This study compares neural activations and emotional responses during imaginal and in vivo exposure. This study also explores the generalizability of fear reduction achieved through imaginal exposure to fear responses elicited by in vivo stimuli, and vice versa, in a follow-up session approximately one week later. A better understanding of the mechanisms behind both types of exposure could have significant clinical utility, as well as elucidate the differences between fear created from outward stimuli and fear created from inward stimuli, such as mental imagery.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Imaginal exposure
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.
Exposure
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.
Approach-avoidance conflict
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).
In vivo exposure
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.

Locations

Country Name City State
Sweden The Swedish 7T facility Lund

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Hoppe JM, Holmes EA, Agren T. Exploring the neural basis of fear produced by mental imagery: imaginal exposure in individuals fearful of spiders. Philos Trans R Soc Lond B Biol Sci. 2021 Feb;376(1817):20190690. doi: 10.1098/rstb.2019.0690. Epub 2020 Dec 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood oxygen level dependent contrast (BOLD-signal) during exposure to fearful stimuli (in vivo or imaginal). BOLD-signal is assessed using functional magnetic resonance imaging. Day 1
Primary Physiological arousal response during exposure (in vivo or imaginal). 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. Day 1
Primary Physiological arousal response during follow-up exposure 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. One week after Day 1
Primary Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli Scale 0-100; no fear at all - extreme fear Day1
Primary Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli Scale 0-100; no fear at all - extreme fear One week after Day 1
Secondary Ratings of subjective fear participants expect to experience during exposure to fearful stimuli Scale 0-100; no fear at all - extreme fear Day 1 & one week after Day 1
Secondary Number of approach-avoidance decisions during an approach-avoidance behaviour task using fearful stimuli (spiders) Number of participants' decisions to avoid looking at a fearful stimuli, or to look at them and be compensated with at small amount. One week after Day 1
Secondary Task-specific mental imagery vividness ratings to fearful and neutral stimuli during imaginal exposure, and follow-up exposure (not applicable during in vivo exposure). Vividness of Imagery (scale: 1-5; no image at all - image as clear and vivid as real life) Day 1 & one week after Day 1
Secondary Spielberger State-Trait Anxiety Inventory (STAI-T) 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 One week after Day 1
Secondary Vividness of visual imagery Questionnaire (VVIQ) 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. One week after Day 1
Secondary Amount of watching film clips (not applicable during imaginal exposure). 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. Day 1 & one week after Day 1
See also
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Completed NCT04162509 - Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders N/A
Completed NCT03907345 - Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure N/A
Recruiting NCT05168592 - The Neural Mechanisms of Imaginal Extinction N/A