Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03653923
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2018-07-24
Brief Title:
Neurophysiological Correlates of Exposition Therapy in Spider Phobia
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Neurophysiological Correlates of Exposition Therapy in Spider Phobia
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the neurophysiological correlates of spider phobia and its treatment with CBT based Exposure Therapy This is the first study to investigate the neurophysiological correlates of Exposure Therapy in situ by means of functional Near-Infrared Spectroscopy fNIRS
30 spider phobic patients will be assessed and randomly allocated to 5 sessions of exposure therapy or waiting-list Further 30 non-phobic control subjects will be assessed primary assessment only
During Exposure Therapy changes in blood oxygenation will be measured with fNIRS in areas of the Cognitive Control Network Regions of interest are the bilateral dorsolateral prefrontal cortex DLPFC bilateral inferior frontal gyrus IFG and somatosensory association cortex SAC Before the treatment subjects will have one session of psychoeducation in which the rationale for the treatment is explained In each therapy session subjects are exposed to 20 trials each lasting 40s of guided exposure by a psychotherapist Further 20 control trials of equal length are assessed in which subjects work with an earthworm During the therapy additional anxiety coping strategies eg controlled breathing attention refocusing cognitive reappraisal are trained After the treatment or waiting-list phase treatment conditions are switched The waiting list will be treated and the treated subject will wait for approximately 6 weeks
Before treatment primary assessment after treatment secondary assessment and after study completion final assessment additional combined NIRS EEG measurements are done On a peripheral physiological level heart rate and EMG of the facial corrugator supercilii are measured During these measurements subjects are asked to watch 10s lasting video clips showing spiders experimental condition or pets dogs and cats On a psychometric level spider phobia will be assessed by questionnaires SPQ FSQ SBQ and behavioral assessments
30 spider phobic patients will be assessed and randomly allocated to 5 sessions of exposure therapy or waiting-list Further 30 non-phobic control subjects will be assessed primary assessment only
During Exposure Therapy changes in blood oxygenation will be measured with fNIRS in areas of the Cognitive Control Network Regions of interest are the bilateral dorsolateral prefrontal cortex DLPFC bilateral inferior frontal gyrus IFG and somatosensory association cortex SAC Before the treatment subjects will have one session of psychoeducation in which the rationale for the treatment is explained In each therapy session subjects are exposed to 20 trials each lasting 40s of guided exposure by a psychotherapist Further 20 control trials of equal length are assessed in which subjects work with an earthworm During the therapy additional anxiety coping strategies eg controlled breathing attention refocusing cognitive reappraisal are trained After the treatment or waiting-list phase treatment conditions are switched The waiting list will be treated and the treated subject will wait for approximately 6 weeks
Before treatment primary assessment after treatment secondary assessment and after study completion final assessment additional combined NIRS EEG measurements are done On a peripheral physiological level heart rate and EMG of the facial corrugator supercilii are measured During these measurements subjects are asked to watch 10s lasting video clips showing spiders experimental condition or pets dogs and cats On a psychometric level spider phobia will be assessed by questionnaires SPQ FSQ SBQ and behavioral assessments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None