Neurophysiological Correlates of Exposition Therapy in Spider Phobia

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03653923
Collaborator
(none)
40
1
3
15
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exposure Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Waiting-List RCT with crossover after Treatment (Waiting-List will be treated, treated subjects will rest)Waiting-List RCT with crossover after Treatment (Waiting-List will be treated, treated subjects will rest)
Masking:
None (Open Label)
Masking Description:
Psychotherapeutic Investigation - No masking possible
Primary Purpose:
Basic Science
Official Title:
Neurophysiological Correlates of Exposition Therapy in Spider Phobia
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Waiting-List

Behavioral: Exposure Therapy
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. Each session lasts for approximately 90 minutes. During the therapy additional anxiety coping strategies (e.g., controlled breathing, attention refocusing, cognitive reappraisal) are trained. Subjects of the waiting-list will be treated in the second study phase.
Other Names:
  • Psychotherapy
  • Experimental: Treatment

    Behavioral: Exposure Therapy
    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. Each session lasts for approximately 90 minutes. During the therapy additional anxiety coping strategies (e.g., controlled breathing, attention refocusing, cognitive reappraisal) are trained. Subjects of the waiting-list will be treated in the second study phase.
    Other Names:
  • Psychotherapy
  • No Intervention: Healthy Controls

    Not randomized healthy control group for comparison to normal functioning

    Outcome Measures

    Primary Outcome Measures

    1. fNIRS [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 Outcome Measures

    1. 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)]

      Range SPQ: 0 to 31, high values indicate high fear of spiders

    2. 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)]

      Avoidance with respect to spiders will be assessed on a behavioral scale = Spider is 5 m away (in a jar) = Patient watches pictures of spiders while the spider is 5 m away = spider is 2 m away (in a jar) = spider is 0.5 m away (in a jar) = spider is directly in front of the subject (in a jar) = spider is taken out of the jar into a larger tub = patient touches the spider with a pen = the spider is on the (covered) hand of the patient = patient touches the spider with his finger = spider walks on the hand of the patient = spider walks up the arm of the patient

    3. 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)]

      Heart rate and electromyography of the facial corrugator supercilii will be assessed

    4. 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)]

      Event-Related Potentials will be assessed with EEG

    5. 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)]

      Range FSQ: 18 to 126, high values indicate high fear of spiders

    6. 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)]

      Range SBQ (mean): 0 to 100%, high values indicate high maladaptive beliefs of spiders

    7. 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)]

      During exposure fear, disgust and aviodance will be rated after each trial by the subject on a scale from 1 (not at all) to 9 (very much)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Psychiatry and Psychotherapy, University Hospital Tuebingen Tuebingen Baden-Württemberg Germany 72076

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

    • Principal Investigator: David Rosenbaum, Dipl.-Psych., Universitiy Hospital of Tuebingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT03653923
    Other Study ID Numbers:
    • 481/2018BO2
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    Oct 9, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 9, 2018