Extinction Generalization in Exposure Therapy
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|ClinicalTrials.gov Identifier: NCT03031002|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Specific Phobia||Behavioral: Exposure treatment for spider fear||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extinction Generalization in Exposure Therapy for Spider Phobia|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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
- Change in the Behavioral Approach Test (BAT) from pre- to posttreatment [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and 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.
- Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS) [ Time Frame: Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment) ]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 [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and 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) [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment) ]
- Change in the Spider Phobia Questionnaire (SPQ) [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment) ]
- Change in the Spider Beliefs Questionnaire (SBQ) [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment) ]
- Epigenetic / DNA methylation [ Time Frame: Pre- and posttreatment (with approximately 4 days between pre- and posttreatment) ]DNA collection kits at pre- and posttreatment
- Depression Anxiety Stress Scales (DASS) [ Time Frame: Pretreatment (assessed once prior to treatment) ]
- Questionnaire for the Assessment of Disgust Sensitivity (FEE) [ Time Frame: Pretreatment (assessed once prior to treatment) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031002
|Principal Investigator:||Armin Zlomuzica, Dr.||Ruhr University of Bochum|