Neurophysiological Correlates of Exposition Therapy in Spider Phobia

NCT ID: NCT03653923

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-01-31

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.

Conditions

Phobic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Waiting-List

Group Type: EXPERIMENTAL

Exposure Therapy

Intervention Type: BEHAVIORAL

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.

Treatment

Group Type: EXPERIMENTAL

Exposure Therapy

Intervention Type: BEHAVIORAL

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.

Healthy Controls

Not randomized healthy control group for comparison to normal functioning

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Psychotherapy

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rosenbaum, Dipl.-Psych.

Role: PRINCIPAL_INVESTIGATOR

Universitiy Hospital of Tuebingen

Locations

Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

David Rosenbaum, Dipl.-Psych.

Role: CONTACT

david.rosenbaum@med.uni-tuebingen.de

07071-29 83609

Facility Contacts

David Rosenbaum, Dipl.-Psych.

Role: primary

David.Rosenbaum@med.uni-tuebingen.de

0049 7071 29 ext. 83609

Ann-Christine Ehlis, PhD

Role: backup

Ann-Christine.Ehlis@med.uni-tuebingen.de

0049 7071 29 ext. 87103

Other Identifiers

481/2018BO2

Identifier Type: -

Identifier Source: org_study_id