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Neurophysiological Correlates of Exposition Therapy in Spider Phobia

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ClinicalTrials.gov Identifier: NCT03653923
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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
Phobic Disorders Behavioral: Exposure Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias

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 Name: 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 Name: Psychotherapy

No Intervention: Healthy Controls
Not randomized healthy control group for comparison to normal functioning



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. spider phobia questionnaire [ 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) ]
    Range SPQ: 0 to 31, high values indicate high fear of spiders

  2. Behavioral Measures [ 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) ]

    Avoidance with respect to spiders will be assessed on a behavioral scale

    1. = Spider is 5 m away (in a jar)
    2. = Patient watches pictures of spiders while the spider is 5 m away
    3. = spider is 2 m away (in a jar)
    4. = spider is 0.5 m away (in a jar)
    5. = spider is directly in front of the subject (in a jar)
    6. = spider is taken out of the jar into a larger tub
    7. = patient touches the spider with a pen
    8. = the spider is on the (covered) hand of the patient
    9. = patient touches the spider with his finger
    10. = spider walks on the hand of the patient
    11. = spider walks up the arm of the patient

  3. Peripheral Physiology [ 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) ]
    Heart rate and electromyography of the facial corrugator supercilii will be assessed

  4. EEG/EKP [ 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) ]
    Event-Related Potentials will be assessed with EEG

  5. Fear of Spiders Questionnaire [ 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) ]
    Range FSQ: 18 to 126, high values indicate high fear of spiders

  6. Spider-Phobia-Beliefs Questionnaire [ 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) ]
    Range SBQ (mean): 0 to 100%, high values indicate high maladaptive beliefs of spiders

  7. Visual analogue scales [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653923


Contacts
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Contact: David Rosenbaum, Dipl.-Psych. 07071-29 83609 david.rosenbaum@med.uni-tuebingen.de

Locations
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Germany
Department of Psychiatry and Psychotherapy, University Hospital Tuebingen Recruiting
Tuebingen, Baden-Württemberg, Germany, 72076
Contact: David Rosenbaum, Dipl.-Psych.    0049 7071 29 ext 83609    David.Rosenbaum@med.uni-tuebingen.de   
Contact: Ann-Christine Ehlis, PhD    0049 7071 29 ext 87103    Ann-Christine.Ehlis@med.uni-tuebingen.de   
Principal Investigator: Ann-Christine Ehlis, Dr.         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: David Rosenbaum, Dipl.-Psych. Universitiy Hospital of Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03653923    
Other Study ID Numbers: 481/2018BO2
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be sent after enquiry

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders