Extinction Generalization in Exposure Therapy

Extinction Generalization in Exposure Therapy for Spider Phobia

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.

Study Overview

• Status: Completed
• Conditions: Specific Phobia
• Intervention / Treatment: Behavioral: Exposure treatment for spider fear

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure Treatment; Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear	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.
No Intervention: No Exposure Treatment; Participants of this arm receive no exposure or other adequate treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Change in the Fear of Spiders Questionnaire (FSQ)		Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Spider Phobia Questionnaire (SPQ)		Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Spider Beliefs Questionnaire (SBQ)		Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epigenetic / DNA methylation	DNA collection kits at pre- and posttreatment	Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)
Depression Anxiety Stress Scales (DASS)		Pretreatment (assessed once prior to treatment)
Questionnaire for the Assessment of Disgust Sensitivity (FEE)		Pretreatment (assessed once prior to treatment)

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Armin Zlomuzica, Dr., Ruhr University of Bochum

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 14, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: exposure; spider phobia; extinction; generalization
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: ZL 59/2-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO