Extinction Generalization in Exposure Therapy
Primary Purpose
Specific Phobia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exposure treatment for spider fear
Sponsored by

About this trial
This is an interventional treatment trial for Specific Phobia focused on measuring exposure, spider phobia, generalization, extinction
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exposure Treatment
No Exposure Treatment
Arm Description
Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear
Participants of this arm receive no exposure or other adequate treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Change in the Fear of Spiders Questionnaire (FSQ)
Change in the Spider Phobia Questionnaire (SPQ)
Change in the Spider Beliefs Questionnaire (SBQ)
Full Information
NCT ID
NCT03031002
First Posted
January 14, 2017
Last Updated
January 24, 2017
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT03031002
Brief Title
Extinction Generalization in Exposure Therapy
Official Title
Extinction Generalization in Exposure Therapy for Spider Phobia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia
Keywords
exposure, spider phobia, generalization, extinction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposure Treatment
Arm Type
Experimental
Arm Description
Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear
Arm Title
No Exposure Treatment
Arm Type
No Intervention
Arm Description
Participants of this arm receive no exposure or other adequate treatment
Intervention Type
Behavioral
Intervention Name(s)
Exposure treatment for spider fear
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Behavioral Approach Test (BAT) from pre- to posttreatment
Description
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.
Time Frame
Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary Outcome Measure Information:
Title
Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)
Description
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.
Time Frame
Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)
Title
Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment
Description
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.
Time Frame
Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Title
Change in the Fear of Spiders Questionnaire (FSQ)
Time Frame
Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Title
Change in the Spider Phobia Questionnaire (SPQ)
Time Frame
Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Title
Change in the Spider Beliefs Questionnaire (SBQ)
Time Frame
Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Other Pre-specified Outcome Measures:
Title
Epigenetic / DNA methylation
Description
DNA collection kits at pre- and posttreatment
Time Frame
Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)
Title
Depression Anxiety Stress Scales (DASS)
Time Frame
Pretreatment (assessed once prior to treatment)
Title
Questionnaire for the Assessment of Disgust Sensitivity (FEE)
Time Frame
Pretreatment (assessed once prior to treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Zlomuzica, Dr.
Organizational Affiliation
Ruhr University of Bochum
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extinction Generalization in Exposure Therapy
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