Phobic DisordersNCT03653923
Neurophysiological Correlates of Exposition Therapy in Spider Phobia
A study testing Exposure Therapy in people with Phobic Disorders, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobic Disorders
- What is being tested?
- Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2018to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Spider Phobia or no fear of spiders
- Age between 18 and 50
- normal vision (or corrected with glasses)
- German mother tongue or comparable knowledge
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
David Rosenbaum, Dipl.-Psych., 0049 7071 29 ext. 83609, David.Rosenbaum@med.uni-tuebingen.de
Ann-Christine Ehlis, PhD, 0049 7071 29 ext. 87103, Ann-Christine.Ehlis@med.uni-tuebingen.de
About this study
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).
Read more
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.
- Conditions
- Phobic Disorders
- Being tested
- Exposure Therapy
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure TherapyBehavioural
Also called Psychotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Waiting-List | Experimental | Not described Receives: Behavioral: Exposure Therapy |
| Treatment | Experimental | Not described Receives: Behavioral: Exposure Therapy |
| Healthy Controls | No intervention | Not randomized healthy control group for comparison to normal functioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (7)
spider phobia questionnaire
Range SPQ: 0 to 31, high values indicate high fear of spiders
Measured: 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
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
Measured: 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
Heart rate and electromyography of the facial corrugator supercilii will be assessed
Measured: 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
Event-Related Potentials will be assessed with EEG
Measured: 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
Range FSQ: 18 to 126, high values indicate high fear of spiders
Measured: 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
Range SBQ (mean): 0 to 100%, high values indicate high maladaptive beliefs of spiders
Measured: 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 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waiting-List RCT with crossover after Treatment (Waiting-List will be treated, treated subjects will rest)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rosenbaum, Dipl.-Psych., Principal investigator, Universitiy Hospital of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653923
- Sponsor's protocol ID
- 481/2018BO2
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be sent after enquiry
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Correlates of Exposition Therapy in Spider Phobia
- ClinicalTrials.gov ID
- NCT03653923
- Acronym / sponsor ID
- 481/2018BO2
- Conditions
- Phobic Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Waiting-List RCT with crossover after Treatment (Waiting-List will be treated, treated subjects will rest)
| Arm | Type | Receives |
|---|---|---|
| Waiting-List | Experimental | Behavioral: Exposure Therapy |
| Treatment | Experimental | Behavioral: Exposure Therapy |
| Healthy Controls | No intervention | –Not randomized healthy control group for comparison to normal functioning |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Spider Phobia or no fear of spiders
- Age between 18 and 50
- normal vision (or corrected with glasses)
- German mother tongue or comparable knowledge
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure TherapyAlso: PsychotherapyBefore 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. | Behavioural | Treatment, Waiting-List |
Primary outcome
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.
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided. IPD will be sent after enquiry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rosenbaum, Dipl.-Psych. principal investigator
Universitiy Hospital of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy in people with Phobic Disorders, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Rosenbaum, Dipl.-Psych. (07071-29 83609, david.rosenbaum@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.