Clinical trial NCT03653923: Neurophysiological Correlates of Exposition Therapy in Spider Phobia
Official title: Neurophysiological Correlates of Exposition Therapy in Spider Phobia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phobic Disorders
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waiting-List RCT with crossover after Treatment (Waiting-List will be treated, treated subjects will rest)
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: fNIRS
timeFrame: 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
Secondary outcomes:
measure: spider phobia questionnaire
timeFrame: Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12)
measure: Behavioral Measures
timeFrame: Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12)
measure: Peripheral Physiology
timeFrame: Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12)
measure: EEG/EKP
timeFrame: Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12)
measure: Fear of Spiders Questionnaire
timeFrame: Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12)
measure: Spider-Phobia-Beliefs Questionnaire
timeFrame: Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12)
measure: Visual analogue scales
timeFrame: 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)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
state: Baden-Württemberg
Study officials:
affiliation: Universitiy Hospital of Tuebingen
name: David Rosenbaum, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References: