- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969160
Neural Activations During Imaginal Exposure in Individuals Fearful of Spiders
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Uppsala, Sweden
- Uppsala University Hospital - Akademiska sjukhuset
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Uppsala, Sweden
- Uppsala University, Departement of Psychology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Significant fear of spiders
Exclusion Criteria:
- Current psychiatric disorder other than spider phobia
- Substance abuse
- Neurological disease
- Psychological treatment or psychotropic medication within six months
- Magnetic resonance imaging contradiction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Imaginal exposure
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
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Imaginal exposure to mental imagery of phobic and neutral stimuli
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood oxygen level dependent contrast (BOLD-signal)
Time Frame: Day 1
|
BOLD-signal is assessed using functional magnetic resonance imaging.
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Day 1
|
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Physiological response during exposure to mental imagery
Time Frame: Day 1
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Skin-conductance responses are used as a measure of physiological response.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological response during exposure to mental imagery
Time Frame: Follow-up (one week after day 1)
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Skin-conductance responses are used as a measure of physiological response.
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Follow-up (one week after day 1)
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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)
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Skin-conductance responses are used as a measure of physiological response.
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Difference between day 1 and the follow-up session (one week after day 1)
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Ratings of subjective fear participants' expect to experience during exposure to mental imagery
Time Frame: Day 1
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Scale: 0-100; no fear at all - extreme fear.
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Day 1
|
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Ratings of subjective fear experienced during exposure to mental imagery
Time Frame: Day 1
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Scale: 0-100; no fear at all - extreme fear.
Fear ratings are completed immediately after the imaginal exposure experimental procedure
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Day 1
|
|
Spielberger State-Trait Anxiety Inventory (STAI-S)
Time Frame: Day 1
|
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).
|
Day 1
|
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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)
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Scale: 0-100; no fear at all - extreme fear.
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Difference between day 1 and the follow-up session (one week after day 1)
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Vividness of mental imagery
Time Frame: Day 1
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Vividness of mental imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).
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Day 1
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Vividness of mental imagery
Time Frame: Follow-up (one week after day 1)
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Vividness of imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).
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Follow-up (one week after day 1)
|
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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)
|
Vividness of imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).
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Difference between day 1 and the follow-up session (one week after day 1)
|
|
Difficulties in emotion regulation scale (DERS)
Time Frame: Day 1
|
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)
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Day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spider Phobia Questionnaire (SPQ)
Time Frame: Recruitment
|
SPQ is a self-rated questionnaire assessing fear of spiders.
A high score in SPQ (>19) is required for inclusion in the study.
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Recruitment
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Spielberger State-Trait Anxiety Inventory (STAI-T)
Time Frame: Day 1
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STAI-T is a self-rated questionnaire assessing trait anxiety and is included to describe the sample in terms of anxiety proneness.
High scores indicate higher levels of trait anxiety (range, total score: 20 - 80)
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Day 1
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Number of intrusive mental imagery of phobic stimuli
Time Frame: 7 days, starting on day 1.
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Number of intrusive mental images of phobic stimuli recorded by participants in a diary, daily (morning, afternoon, evening and night) for 7 days.
This measure is included as a manipulation check.
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7 days, starting on day 1.
|
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Demand questions
Time Frame: Day 1
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Two questions asking participants' to appreciate the emotional impact of producing mental imagery versus focusing on the verbal aspects of phobic situations used in the experimental procedure.
This measure is included as a manipulation check.
|
Day 1
|
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The Plymouth Sensory Imagery Questionnaire (Psi-Q)
Time Frame: Day 1
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The Psi-Q is a self-rated measure of vividness of imagery across different sensory modalities.
Higher scores indicate higher levels of vividness (range, total score 0 - 70).
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Day 1
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017/419
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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