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Clinical Trials/NCT03653923
NCT03653923UnknownNot Applicable

Neurophysiological Correlates of Exposition Therapy in Spider Phobia

University Hospital Tuebingen2 sites in 1 country40 target enrollmentStarted: October 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
2
Primary Endpoint
fNIRS

Study Overview

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 (e.g., 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Masking Description

Psychotherapeutic Investigation - No masking possible

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Spider Phobia or no fear of spiders
  • Age between 18 and 50
  • normal vision (or corrected with glasses)
  • German mother tongue or comparable knowledge

Exclusion Criteria

  • pregnancy
  • medication with exception of contraceptive medication
  • acute or chronic disease that affects brain functioning (other mental diagnosis than spider phobia, cardial diseases, diabetes, kidney diseases, concussion)

Arms & Interventions

Waiting-List

Experimental

Intervention: Exposure Therapy (Behavioral)

Treatment

Experimental

Intervention: Exposure Therapy (Behavioral)

Healthy Controls

No Intervention

Not randomized healthy control group for comparison to normal functioning

Outcomes

Primary Outcomes

fNIRS

Time Frame: Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12); During Exposure Therapy

Oxygenated and Deoxygenated Blood in the cerebral cortex will be measured with functional Near-Infrared Spectroscopy. Analysed will be Changes in Oxygenated Blood from Pre to Post-Measurement and between Control Conditions (EarthWorm) and Experimental Conditions (Working with Spiders). At Pre-Testing, the clinical population will be compared to the healthy controls.

Secondary Outcomes

  • spider phobia questionnaire(Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12))
  • Behavioral Measures(Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12))
  • Peripheral Physiology(Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12))
  • EEG/EKP(Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12))
  • Fear of Spiders Questionnaire(Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12))
  • Spider-Phobia-Beliefs Questionnaire(Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12))
  • Visual analogue scales(During each exposure session (week 1 to 5) and during EEG assessments (Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (approximately week 12))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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