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Neurophysiological Correlates of Exposition Therapy in Spider Phobia

Primary Purpose

Phobic Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exposure Therapy
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Phobic Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University Hospital TuebingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Waiting-List

Treatment

Healthy Controls

Arm Description

Not randomized healthy control group for comparison to normal functioning

Outcomes

Primary Outcome Measures

fNIRS
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

spider phobia questionnaire
Range SPQ: 0 to 31, high values indicate high fear of spiders
Behavioral Measures
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
Peripheral Physiology
Heart rate and electromyography of the facial corrugator supercilii will be assessed
EEG/EKP
Event-Related Potentials will be assessed with EEG
Fear of Spiders Questionnaire
Range FSQ: 18 to 126, high values indicate high fear of spiders
Spider-Phobia-Beliefs Questionnaire
Range SBQ (mean): 0 to 100%, high values indicate high maladaptive beliefs of spiders
Visual analogue scales
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)

Full Information

First Posted
July 24, 2018
Last Updated
October 4, 2018
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03653923
Brief Title
Neurophysiological Correlates of Exposition Therapy in Spider Phobia
Official Title
Neurophysiological Correlates of Exposition Therapy in Spider Phobia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobic Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waiting-List
Arm Type
Experimental
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
Not randomized healthy control group for comparison to normal functioning
Intervention Type
Behavioral
Intervention Name(s)
Exposure Therapy
Other Intervention Name(s)
Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
fNIRS
Description
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.
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
Secondary Outcome Measure Information:
Title
spider phobia questionnaire
Description
Range SPQ: 0 to 31, high values indicate high fear of spiders
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)
Title
Behavioral Measures
Description
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
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)
Title
Peripheral Physiology
Description
Heart rate and electromyography of the facial corrugator supercilii will be assessed
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)
Title
EEG/EKP
Description
Event-Related Potentials will be assessed with EEG
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)
Title
Fear of Spiders Questionnaire
Description
Range FSQ: 18 to 126, high values indicate high fear of spiders
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)
Title
Spider-Phobia-Beliefs Questionnaire
Description
Range SBQ (mean): 0 to 100%, high values indicate high maladaptive beliefs of spiders
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)
Title
Visual analogue scales
Description
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Rosenbaum, Dipl.-Psych.
Phone
07071-29 83609
Email
david.rosenbaum@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosenbaum, Dipl.-Psych.
Organizational Affiliation
Universitiy Hospital of Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Rosenbaum, Dipl.-Psych.
Phone
0049 7071 29
Ext
83609
Email
David.Rosenbaum@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Ann-Christine Ehlis, PhD
Phone
0049 7071 29
Ext
87103
Email
Ann-Christine.Ehlis@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Ann-Christine Ehlis, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be sent after enquiry

Learn more about this trial

Neurophysiological Correlates of Exposition Therapy in Spider Phobia

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