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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
Sponsor:
Information provided by (Responsible Party):
Armin Zlomuzica, Ruhr University of Bochum

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.

Condition or disease Intervention/treatment Phase
Specific Phobia Behavioral: Exposure treatment for spider fear Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in the Fear of Spiders Questionnaire (FSQ) [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment) ]
  4. Change in the Spider Phobia Questionnaire (SPQ) [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment) ]
  5. Change in the Spider Beliefs Questionnaire (SBQ) [ Time Frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment) ]

Other Outcome Measures:
  1. Epigenetic / DNA methylation [ Time Frame: Pre- and posttreatment (with approximately 4 days between pre- and posttreatment) ]
    DNA collection kits at pre- and posttreatment

  2. Depression Anxiety Stress Scales (DASS) [ Time Frame: Pretreatment (assessed once prior to treatment) ]
  3. Questionnaire for the Assessment of Disgust Sensitivity (FEE) [ Time Frame: Pretreatment (assessed once prior to treatment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Armin Zlomuzica, Dr. Ruhr University of Bochum
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Responsible Party: Armin Zlomuzica, Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT03031002    
Other Study ID Numbers: ZL 59/2-2
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Armin Zlomuzica, Ruhr University of Bochum:
exposure
spider phobia
generalization
extinction
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders