Clinical trial NCT03031002: Extinction Generalization in Exposure Therapy
Official title: Extinction Generalization in Exposure Therapy for Spider Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Keywords: exposure
spider phobia
generalization
extinction
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with anxiety disorders oftentimes express fear responses to more than only one fear-inducing object. The principal aim of this study is to examine whether the beneficial effects of exposure on fear reduction in spider phobia can extend to stimuli which are conceptually similar to spiders (i.e. cockroaches), but have never been presented during the respective treatment.

Detailed description: Fear extinction has evolved as the central mechanism underlying exposure-based treatments. Findings from conditioning studies indicate that fear reduction following a fear extinction procedure can generalize from the extinction stimulus to other conceptually and perceptually related stimuli. This study is aimed at translating these findings to a clinical application and will hence examine whether the basic principles of extinction generalization are applicable to exposure.

Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders or no treatment. Prior to as well as after treatment, patient's fear of spiders will be assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy on extinction generalization.

Eligibility criteria: Inclusion Criteria:

* spider phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria

Exclusion Criteria:

* any neurological or neuropsychiatric condition
* current behavioral or pharmacological treatment
* any mental disorder that is considered more severe than specific phobia

Primary outcomes:
measure: Change in the Behavioral Approach Test (BAT) from pre- to posttreatment
timeFrame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary outcomes:
measure: Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)
timeFrame: Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment
timeFrame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Change in the Fear of Spiders Questionnaire (FSQ)
timeFrame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Change in the Spider Phobia Questionnaire (SPQ)
timeFrame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Change in the Spider Beliefs Questionnaire (SBQ)
timeFrame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Other outcomes:
measure: Epigenetic / DNA methylation
timeFrame: Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Depression Anxiety Stress Scales (DASS)
timeFrame: Pretreatment (assessed once prior to treatment)
measure: Questionnaire for the Assessment of Disgust Sensitivity (FEE)
timeFrame: Pretreatment (assessed once prior to treatment)
Locations:
Study officials:
affiliation: Ruhr University of Bochum
name: Armin Zlomuzica, Dr.
role: PRINCIPAL_INVESTIGATOR
References: