Neurophysiological Correlates of Exposition Therapy in Spider Phobia

NCT03653923 | Unknown

• 1 other identifier: 481/2018BO2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Before Treatment (Primary Assessment, approximately week 1), after treatment completion (secondary assessment, approximately week 6) and after study completion (final assessment, approximately week 12)

Study Arms (3)

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

Interventions

Exposure Therapy 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.

Also known as: Psychotherapy

Treatment; Waiting-List

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Spider Phobia or no fear of spiders
• Age between 18 and 50
• normal vision (or corrected with glasses)
• German mother tongue or comparable knowledge

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Phobic Disorders

Interventions

Implosive Therapy; Psychotherapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Behavioral Disciplines and Activities

Study Officials

• David Rosenbaum, Dipl.-Psych.

  Universitiy Hospital of Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Rosenbaum, Dipl.-Psych.

CONTACT

07071-29 83609; david.rosenbaum@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Psychotherapeutic Investigation - No masking possible
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Waiting-List RCT with crossover after Treatment (Waiting-List will be treated, treated subjects will rest)

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: October 9, 2018

Record last verified: 2018-07

Locations

DE (1)