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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
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring exposure, spider phobia, generalization, extinction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 14, 2017
    Last Updated
    January 24, 2017
    Sponsor
    Ruhr University of Bochum
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    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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