Individuals With Fear of SpidersNCT03969160
Neural Activations During Imaginal Exposure in Individuals Fearful of Spiders
A study testing Imaginal exposure in people with Individuals With Fear of Spiders, run by Uppsala University at 2 sites in Sweden.
Trial summary
This study explores the brain basis of imaginal exposure, a widely used psychological treatment technique. Specifically, this study uses functional magnetic resonance imaging to examine brain areas activated during imaginal exposure, in individuals fearful of spiders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Individuals With Fear of Spiders
- What is being tested?
- Imaginal exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSweden
- Study dates
- 11 Nov 2017to 22 Feb 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Significant fear of spiders
Who cannot join
- Current psychiatric disorder other than spider phobia
- Substance abuse
- Neurological disease
- Psychological treatment or psychotropic medication within six months
- Magnetic resonance imaging contradiction
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Uppsala University Hospital - Akademiska sjukhuset
Uppsala
Uppsala University, Departement of Psychology
Uppsala
About this study
This study explores the brain basis of imaginal exposure, a widely used psychological treatment technique. Specifically, this study uses functional magnetic resonance imaging to examine brain areas activated during imaginal exposure, in individuals fearful of spiders. Physiological responses and subjective fear experienced during imaginal exposure are also assessed.
The primary aim of this study is to explore differences in neural activity during exposure to phobic, compared to neutral, mental imagery. The study will focus primarily on exploratory whole brain analyses, but will also include regions of interest analyses on brain areas previously associated with imaginal exposure. The experimental procedure consists of repeated exposure to mental imagery, i.e. imagery of short durations, including either highly emotion-provoking or neutral content, prompted by verbal instructions. A secondary aim is to explore the effects of repeated exposure to mental imagery, used during the experimental procedure, on subjective fear and physiological responses.
Read the detailed description
Results will elucidate if neural activity to phobic imagery differs from activity associated with the production of mental imagery per se. Findings will also increase our general understanding of the neural basis of imaginal exposure treatments.
- Conditions
- Individuals With Fear of Spiders
- Being tested
- Imaginal exposure
- Keywords
- Imaginal exposure, brain imaging, mental imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginal exposureBehavioural
Imaginal exposure to mental imagery of phobic and neutral stimuli
| Study group | Role | What they receive |
|---|---|---|
| Imaginal exposure | Experimental | The experimental procedure consists of imaginal exposure to mental imagery of phobic and neutral stimuli, prompted through recorded verbal instructions. Participants' repeat the experimental procedure one week later in a follow-up session. Brain imaging data is only collected during day 1 Receives: Behavioral: Imaginal 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)
BOLD-signal is assessed using functional magnetic resonance imaging.
Measured: Day 1
Physiological response during exposure to mental imagery
Skin-conductance responses are used as a measure of physiological response.
Measured: Day 1
Secondary outcomes (10)
Physiological response during exposure to mental imagery
Skin-conductance responses are used as a measure of physiological response.
Measured: Follow-up (one week after day 1)
Differences in physiological response during exposure to mental imagery, during day 1 compared to the follow-up session.
Skin-conductance responses are used as a measure of physiological response.
Measured: Difference between day 1 and the follow-up session (one week after day 1)
Ratings of subjective fear participants' expect to experience during exposure to mental imagery
Scale: 0-100; no fear at all - extreme fear.
Measured: Day 1
Ratings of subjective fear experienced during exposure to mental imagery
Scale: 0-100; no fear at all - extreme fear. Fear ratings are completed immediately after the imaginal exposure experimental procedure
Measured: Day 1
Spielberger State-Trait Anxiety Inventory (STAI-S)
STAI-S is a self-rated questionnaire included to assess state-anxiety experienced during exposure. High scores indicate high levels of state anxiety (range, total score: 20 - 80).
Measured: Day 1
Differences in ratings of subjective fear during exposure to mental imagery, during day 1 compared to the follow-up session.
Scale: 0-100; no fear at all - extreme fear.
Measured: Difference between day 1 and the follow-up session (one week after day 1)
Vividness of mental imagery
Vividness of mental imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).
Measured: Day 1
Vividness of mental imagery
Vividness of imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).
Measured: Follow-up (one week after day 1)
Differences in vividness of mental imagery, during day 1 compared to the follow-up session.
Vividness of imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).
Measured: Difference between day 1 and the follow-up session (one week after day 1)
Difficulties in emotion regulation scale (DERS)
DERS is a self-rated questionnaire, included to explore potential relations between imaginal exposure and difficulties in emotion regulation. High scores indicate more difficulties in emotion regulation (range, total score: 36 - 180)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start11 Nov 2017
- Primary completion14 Feb 2018
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individuals With 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969160
- Sponsor's protocol ID
- 2017/419
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Activations During Imaginal Exposure in Individuals Fearful of Spiders
- ClinicalTrials.gov ID
- NCT03969160
- Acronym / sponsor ID
- 2017/419
- Conditions
- Individuals With Fear of Spiders
- Keywords
- Imaginal exposure, brain imaging, mental imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 31 May 2019 (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.
This study explores the brain basis of imaginal exposure, a widely used psychological treatment technique. Specifically, this study uses functional magnetic resonance imaging to examine brain areas activated during imaginal exposure, in individuals fearful of spiders. Physiological responses and subjective fear experienced during imaginal exposure are also assessed.
The primary aim of this study is to explore differences in neural activity during exposure to phobic, compared to neutral, mental imagery. The study will focus primarily on exploratory whole brain analyses, but will also include regions of interest analyses on brain areas previously associated with imaginal exposure. The experimental procedure consists of repeated exposure to mental imagery, i.e. imagery of short durations, including either highly emotion-provoking or neutral content, prompted by verbal instructions. A secondary aim is to explore the effects of repeated exposure to mental imagery, used during the experimental procedure, on subjective fear and physiological responses.
Detailed description
Results will elucidate if neural activity to phobic imagery differs from activity associated with the production of mental imagery per se. Findings will also increase our general understanding of the neural basis of imaginal exposure treatments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaginal exposure | Experimental | Behavioral: Imaginal exposureThe experimental procedure consists of imaginal exposure to mental imagery of phobic and neutral stimuli, prompted through recorded verbal instructions. Participants' repeat the experimental procedure one week later in a follow-up session. Brain imaging data is only collected during day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Significant fear of spiders
Key exclusion criteria (5 listed)
- Current psychiatric disorder other than spider phobia
- Substance abuse
- Neurological disease
- Psychological treatment or psychotropic medication within six months
- Magnetic resonance imaging contradiction
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 exposureImaginal exposure to mental imagery of phobic and neutral stimuli | Behavioural | Imaginal exposure |
Primary outcome
Blood oxygen level dependent contrast (BOLD-signal)
Time frame: Day 1
BOLD-signal is assessed using functional magnetic resonance imaging.
Physiological response during exposure to mental imagery
Time frame: Day 1
Skin-conductance responses are used as a measure of physiological response.
10 secondary outcomes
Physiological response during exposure to mental imagery
Time frame: Follow-up (one week after day 1)
Differences in physiological response during exposure to mental imagery, during day 1 compared to the follow-up session.
Time frame: Difference between day 1 and the follow-up session (one week after day 1)
Ratings of subjective fear participants' expect to experience during exposure to mental imagery
Time frame: Day 1
Ratings of subjective fear experienced during exposure to mental imagery
Time frame: Day 1
Spielberger State-Trait Anxiety Inventory (STAI-S)
Time frame: Day 1
Differences in ratings of subjective fear during exposure to mental imagery, during day 1 compared to the follow-up session.
Time frame: Difference between day 1 and the follow-up session (one week after day 1)
Vividness of mental imagery
Time frame: Day 1
Vividness of mental imagery
Time frame: Follow-up (one week after day 1)
Differences in vividness of mental imagery, during day 1 compared to the follow-up session.
Time frame: Difference between day 1 and the follow-up session (one week after day 1)
Difficulties in emotion regulation scale (DERS)
Time frame: 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 31 May 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginal exposure in people with Individuals With Fear of Spiders, run by Uppsala University at 2 sites 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 1 inclusion and 5 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 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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) (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 31 May 2019.