Fear of SpidersNCT05193383
Neural Mechanisms of Imaginal and in Vivo Exposure
A study testing Imaginal exposure, Exposure and Approach-avoidance conflict in people with Fear of Spiders, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Spiders
- What is being tested?
- Imaginal exposure, Exposure and Approach-avoidance conflict
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSweden
- Study dates
- 7 Apr 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide informed consent and complete study procedures
- Fear of spiders
Who cannot join
- Current psychiatric disorder other than spider phobia
- Current use of psychotropic medication
- Current neurological conditions
- MRI-contraindications (i.e metal implants in skull)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Mechanisms of Imaginal and in Vivo Exposure: Exploring the Differences Between Imaginal and in Vivo Exposure, Using fMRI and Psychophysiology
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.
Read the 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.
- Conditions
- Fear of Spiders
- Being tested
- Imaginal exposure, Exposure, Approach-avoidance conflict, In vivo exposure
- Keywords
- Imaginal exposure, Exposure, Mental Imagery
- Medical subject headings
- Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginal exposureBehavioural
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.
ExposureBehavioural
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 conflictBehavioural
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 exposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaginal exposure | Experimental | Exposure to mental imagery including a fearful stimulus (spider) and corresponding scenes including a neutral stimulus (leaf) Receives: Behavioral: Imaginal exposure; Behavioral: Exposure; Behavioral: Approach-avoidance conflict |
| In vivo exposure | Experimental | Exposure to video clips including a fearful stimulus (spider) and corresponding clips including a neutral stimulus (leaf) Receives: Behavioral: Exposure; Behavioral: Approach-avoidance conflict; Behavioral: In vivo exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day1
Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli
Scale 0-100; no fear at all - extreme fear
Measured: One week after Day 1
Secondary outcomes (6)
Ratings of subjective fear participants expect to experience during exposure to fearful stimuli
Scale 0-100; no fear at all - extreme fear
Measured: Day 1 & one week after Day 1
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.
Measured: 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).
Vividness of Imagery (scale: 1-5; no image at all - image as clear and vivid as real life)
Measured: Day 1 & one week after Day 1
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
Measured: One week after Day 1
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.
Measured: One week after Day 1
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.
Measured: Day 1 & one week after Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start7 Apr 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of SpidersStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Ågren, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193383
- Sponsor's protocol ID
- 2020-06930a
- Status last verified
- Aug 2024
- First submitted
- 9 Dec 2021
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/).
Publications
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.
PubMed 33308073
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Imaginal and in Vivo Exposure: Exploring the Differences Between Imaginal and in Vivo Exposure, Using fMRI and Psychophysiology
- ClinicalTrials.gov ID
- NCT05193383
- Acronym / sponsor ID
- 2020-06930a
- Conditions
- Fear of Spiders
- Keywords
- Imaginal exposure, Exposure, Mental Imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaginal exposure | Experimental | Behavioral: Imaginal exposure, Behavioral: Exposure, Behavioral: Approach-avoidance conflictExposure to mental imagery including a fearful stimulus (spider) and corresponding scenes including a neutral stimulus (leaf) |
| In vivo exposure | Experimental | Behavioral: Exposure, Behavioral: Approach-avoidance conflict, Behavioral: In vivo exposureExposure to video clips including a fearful stimulus (spider) and corresponding clips including a neutral stimulus (leaf) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Willing and able to provide informed consent and complete study procedures
- Fear of spiders
Key exclusion criteria (4 listed)
- Current psychiatric disorder other than spider phobia
- Current use of psychotropic medication
- Current neurological conditions
- MRI-contraindications (i.e metal implants in skull)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaginal exposureSession 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. | Behavioural | Imaginal exposure |
| ExposureSession 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. | Behavioural | Imaginal exposure, In vivo exposure |
| Approach-avoidance conflictSession 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). | Behavioural | Imaginal exposure, In vivo exposure |
| In vivo exposureSession 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. | Behavioural | In vivo exposure |
Primary outcome
Blood oxygen level dependent contrast (BOLD-signal) during exposure to fearful stimuli (in vivo or imaginal).
Time frame: Day 1
BOLD-signal is assessed using functional magnetic resonance imaging.
Physiological arousal response during exposure (in vivo or imaginal).
Time frame: Day 1
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.
Physiological arousal response during follow-up exposure
Time frame: One week after Day 1
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.
Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli
Time frame: Day1
Scale 0-100; no fear at all - extreme fear
Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli
Time frame: One week after Day 1
Scale 0-100; no fear at all - extreme fear
6 secondary outcomes
Ratings of subjective fear participants expect to experience during exposure to fearful stimuli
Time frame: Day 1 & one week after Day 1
Number of approach-avoidance decisions during an approach-avoidance behaviour task using fearful stimuli (spiders)
Time frame: 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).
Time frame: Day 1 & one week after Day 1
Spielberger State-Trait Anxiety Inventory (STAI-T)
Time frame: One week after Day 1
Vividness of visual imagery Questionnaire (VVIQ)
Time frame: One week after Day 1
Amount of watching film clips (not applicable during imaginal exposure).
Time frame: Day 1 & one week after Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Results publication: PubMed 33308073Hoppe 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.
- Individual participant dataSharing planned: Yes. 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/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ågren, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginal exposure, Exposure and Approach-avoidance conflict in people with Fear of Spiders, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen level dependent contrast (BOLD-signal) during exposure to fearful stimuli (in vivo or imaginal). (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05193383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.