Fear of SpidersNCT05168592
The Neural Mechanisms of Imaginal Extinction
A study testing Threat conditioning and Imaginal extinction 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 in which patients are exposed to fearful stimuli and situations using mental imagery. This study examines imaginal extinction, an experimental analogue of imaginal exposure that allows the study of this treatment technique under… 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?
- Threat conditioning and Imaginal extinction
- 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 (due to data collection together with ID 2020-06930a)
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: Exploring the Neural Mechanisms of Imaginal Extinction Using fMRI and Psychophysiology
Imaginal exposure is a widely used and effective psychological treatment technique in which patients are exposed to fearful stimuli and situations using mental imagery. This study examines imaginal extinction, an experimental analogue of imaginal exposure that allows the study of this treatment technique under controlled circumstances. During imaginal extinction, conditioned fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. The neural underpinnings of imaginal extinction is not known, and hence, this study examines neural activations during imaginal extinction using psychophysiology and brain imaging.
Read the 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).
- Conditions
- Fear of Spiders
- Being tested
- Threat conditioning, Imaginal extinction
- Keywords
- Threat conditioning, Extinction, Imaginal Extinction, 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.
Threat conditioningBehavioural
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.
Imaginal extinctionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaginal extinction | Experimental | Conditioned fear will be diminished using imaginal extinction. Receives: Behavioral: Threat conditioning; Behavioral: Imaginal extinction |
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 threat conditioning and imaginal extinction.
BOLD-signal is assessed using functional magnetic resonance imaging.
Measured: Day 1
Physiological arousal response during threat conditioning and imaginal extinction.
Skin conductance responses are used as a measure of physiological arousal response (i.e. event-related rise in electrodermal activity to stimuli).
Measured: Day 1
Secondary outcomes (4)
Task-specific mental imagery vividness during imaginal extinction
Vividness of Imagery (scale:1-5; no image at all - image as clear and vivid as real life)
Measured: Day 1
Ratings of subjective fear experienced during threat conditioning and imaginal extinction.
Scale 0-100; no fear at all - extreme fear
Measured: Day 1
Spielberger State-Trait Anxiety Inventory (STAI-T)
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.
Measured: One week after Day 1
Vividness of visual imagery Questionnaire (VVIQ)
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.
Measured: 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 posted23 Dec 2021
- 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.
- 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
- Not applicable
- Intervention model
- Single group
- 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
- Thoma Ågren, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168592
- Sponsor's protocol ID
- 2020-06930b
- 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/s54dz/).
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
- Exploring the Neural Mechanisms of Imaginal Extinction Using fMRI and Psychophysiology
- ClinicalTrials.gov ID
- NCT05168592
- Acronym / sponsor ID
- 2020-06930b
- Conditions
- Fear of Spiders
- Keywords
- Threat conditioning, Extinction, Imaginal Extinction, 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
- 23 Dec 2021 (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 in which patients are exposed to fearful stimuli and situations using mental imagery. This study examines imaginal extinction, an experimental analogue of imaginal exposure that allows the study of this treatment technique under controlled circumstances. During imaginal extinction, conditioned fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. The neural underpinnings of imaginal extinction is not known, and hence, this study examines neural activations during imaginal extinction using psychophysiology and brain imaging.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaginal extinction | Experimental | Behavioral: Threat conditioning, Behavioral: Imaginal extinctionConditioned fear will be diminished using imaginal extinction. |
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 (due to data collection together with ID 2020-06930a)
Key exclusion criteria (1 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 |
|---|---|---|
| Threat conditioningDay 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. | Behavioural | Imaginal extinction |
| Imaginal extinctionDay 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. | Behavioural | Imaginal extinction |
Primary outcome
Blood oxygen level dependent contrast (BOLD-signal) during threat conditioning and imaginal extinction.
Time frame: Day 1
BOLD-signal is assessed using functional magnetic resonance imaging.
Physiological arousal response during threat conditioning and imaginal extinction.
Time frame: Day 1
Skin conductance responses are used as a measure of physiological arousal response (i.e. event-related rise in electrodermal activity to stimuli).
4 secondary outcomes
Task-specific mental imagery vividness during imaginal extinction
Time frame: Day 1
Ratings of subjective fear experienced during threat conditioning and imaginal extinction.
Time frame: 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
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.
- 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/s54dz/).
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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.
Thoma 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 Threat conditioning and Imaginal extinction 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 1 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 threat conditioning and imaginal extinction. (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.