Extinction Generalization in Exposure Therapy

Specific Phobia Clinical Trial

Official title:

Extinction Generalization in Exposure Therapy for Spider Phobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031002
• Other study ID #: ZL 59/2-2
• Status: Completed
• Phase: N/A
• First received: January 14, 2017
• Last updated: January 24, 2017
• Start date: February 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Phobic Disorders
• Specific Phobia

Intervention

Behavioral:
• Exposure treatment for spider fear
Two sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epigenetic / DNA methylation	DNA collection kits at pre- and posttreatment	Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)
Other	Depression Anxiety Stress Scales (DASS)		Pretreatment (assessed once prior to treatment)
Other	Questionnaire for the Assessment of Disgust Sensitivity (FEE)		Pretreatment (assessed once prior to treatment)
Primary	Change in the Behavioral Approach Test (BAT) from pre- to posttreatment	Behavioral Approach Tests with Spiders and Cockroaches will be conducted at pre- and posttreatment. Here, the closest proximity a participant is able to attain to the spider/cockroach will be measured.	Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary	Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)	Subjective Fear / Disgust during the Behavioral Approach will be assessed at the initial and final approach distances to the spider / cockroach during the respective BATs.	Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary	Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment	During each BAT with spiders and cockroaches, heart rate will be measured. In addition, a 5-minute baseline will be recorded prior to the first BAT at each assessment.	Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary	Change in the Fear of Spiders Questionnaire (FSQ)		Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary	Change in the Spider Phobia Questionnaire (SPQ)		Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary	Change in the Spider Beliefs Questionnaire (SBQ)		Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)