Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT03969160
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2019-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Activations During Imaginal Exposure in Individuals Fearful of Spiders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007171', 'term': 'Implosive Therapy'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Spider Phobia Questionnaire (SPQ)', 'timeFrame': 'Recruitment', 'description': 'SPQ is a self-rated questionnaire assessing fear of spiders. A high score in SPQ (\\>19) is required for inclusion in the study.'}, {'measure': 'Spielberger State-Trait Anxiety Inventory (STAI-T)', 'timeFrame': 'Day 1', 'description': '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)'}, {'measure': 'Number of intrusive mental imagery of phobic stimuli', 'timeFrame': '7 days, starting on day 1.', 'description': '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.'}, {'measure': 'Demand questions', 'timeFrame': 'Day 1', 'description': "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."}, {'measure': 'The Plymouth Sensory Imagery Questionnaire (Psi-Q)', 'timeFrame': 'Day 1', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Blood oxygen level dependent contrast (BOLD-signal)', 'timeFrame': 'Day 1', 'description': 'BOLD-signal is assessed using functional magnetic resonance imaging.'}, {'measure': 'Physiological response during exposure to mental imagery', 'timeFrame': 'Day 1', 'description': 'Skin-conductance responses are used as a measure of physiological response.'}], 'secondaryOutcomes': [{'measure': 'Physiological response during exposure to mental imagery', 'timeFrame': 'Follow-up (one week after day 1)', 'description': 'Skin-conductance responses are used as a measure of physiological response.'}, {'measure': 'Differences in physiological response during exposure to mental imagery, during day 1 compared to the follow-up session.', 'timeFrame': 'Difference between day 1 and the follow-up session (one week after day 1)', 'description': 'Skin-conductance responses are used as a measure of physiological response.'}, {'measure': "Ratings of subjective fear participants' expect to experience during exposure to mental imagery", 'timeFrame': 'Day 1', 'description': 'Scale: 0-100; no fear at all - extreme fear.'}, {'measure': 'Ratings of subjective fear experienced during exposure to mental imagery', 'timeFrame': 'Day 1', 'description': 'Scale: 0-100; no fear at all - extreme fear. Fear ratings are completed immediately after the imaginal exposure experimental procedure'}, {'measure': 'Spielberger State-Trait Anxiety Inventory (STAI-S)', 'timeFrame': 'Day 1', 'description': '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).'}, {'measure': 'Differences in ratings of subjective fear during exposure to mental imagery, during day 1 compared to the follow-up session.', 'timeFrame': 'Difference between day 1 and the follow-up session (one week after day 1)', 'description': 'Scale: 0-100; no fear at all - extreme fear.'}, {'measure': 'Vividness of mental imagery', 'timeFrame': 'Day 1', 'description': 'Vividness of mental imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).'}, {'measure': 'Vividness of mental imagery', 'timeFrame': 'Follow-up (one week after day 1)', 'description': 'Vividness of imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).'}, {'measure': 'Differences in vividness of mental imagery, during day 1 compared to the follow-up session.', 'timeFrame': 'Difference between day 1 and the follow-up session (one week after day 1)', 'description': 'Vividness of imagery of phobic stimuli (scale: 1-5; no image at all - image as clear and vivid as real life).'}, {'measure': 'Difficulties in emotion regulation scale (DERS)', 'timeFrame': 'Day 1', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imaginal exposure', 'brain imaging', 'mental imagery'], 'conditions': ['Individuals With Fear of Spiders']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Significant fear of spiders\n\nExclusion Criteria:\n\n* Current psychiatric disorder other than spider phobia\n* Substance abuse\n* Neurological disease\n* Psychological treatment or psychotropic medication within six months\n* Magnetic resonance imaging contradiction'}, 'identificationModule': {'nctId': 'NCT03969160', 'briefTitle': 'Neural Activations During Imaginal Exposure in Individuals Fearful of Spiders', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Neural Activations During Imaginal Exposure in Individuals Fearful of Spiders', 'orgStudyIdInfo': {'id': '2017/419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imaginal exposure', 'description': "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", 'interventionNames': ['Behavioral: Imaginal exposure']}], 'interventions': [{'name': 'Imaginal exposure', 'type': 'BEHAVIORAL', 'description': 'Imaginal exposure to mental imagery of phobic and neutral stimuli', 'armGroupLabels': ['Imaginal exposure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital - Akademiska sjukhuset', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University, Departement of Psychology', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}