Neural Mechanisms of Imaginal and in Vivo Exposure
1 other identifier
interventional
87
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedStudy Start
First participant enrolled
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedAugust 26, 2024
August 1, 2024
11 months
December 9, 2021
August 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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
Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli
Scale 0-100; no fear at all - extreme fear
Day1
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 Outcomes (6)
Ratings of subjective fear participants expect to experience during exposure to fearful stimuli
Day 1 & one week after Day 1
Number of approach-avoidance decisions during an approach-avoidance behaviour task using fearful stimuli (spiders)
One week after Day 1
Task-specific mental imagery vividness ratings to fearful and neutral stimuli during imaginal exposure, and follow-up exposure (not applicable during in vivo exposure).
Day 1 & one week after Day 1
Spielberger State-Trait Anxiety Inventory (STAI-T)
One week after Day 1
Vividness of visual imagery Questionnaire (VVIQ)
One week after Day 1
- +1 more secondary outcomes
Study Arms (2)
Imaginal exposure
EXPERIMENTALExposure to mental imagery including a fearful stimulus (spider) and corresponding scenes including a neutral stimulus (leaf)
In vivo exposure
EXPERIMENTALExposure to video clips including a fearful stimulus (spider) and corresponding clips including a neutral stimulus (leaf)
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- Willing and able to provide informed consent and complete study procedures
- Fear of spiders
You may not qualify if:
- Current psychiatric disorder other than spider phobia
- Current use of psychotropic medication
- Current neurological conditions
- MRI-contraindications (i.e metal implants in skull)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Swedish 7T facility
Lund, 22242, Sweden
Related 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 14.
PMID: 33308073RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Ă…gren, PhD
Uppsala University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2021
First Posted
January 14, 2022
Study Start
April 7, 2022
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
August 26, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available from completion of analysis and publication, and onwards.
- Access Criteria
- Anonymous behavioural and brain imaging data, training material, Statistical Analysis plan, and informed consent form will be made public on the project site on Open Science Framework (https://osf.io/vmrpw/).
We plan to share anonymous behavioural and brain imaging data, training material, Statistical Analysis plan, and informed consent form on the project site on Open Science Framework (https://osf.io/vmrpw/).