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Completed

NCT Number: NCT03031002

Extinction Generalization in Exposure Therapy

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.

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Key information

Conditions

Specific Phobia Arachnophobia Phobia, Specific

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure treatment for spider fear

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Extinction Generalization in Exposure Therapy for Spider Phobia

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2017
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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