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Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure

Primary Purpose

Fear of Spiders, Fear of Heights

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exposure
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fear of Spiders focused on measuring Exposure Therapy, Fear of Spiders, Fear of Heights, Anxiety Disorders, Generalization, Extinction, Specific Phobias

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Comorbid presence of fear of spiders and fear of heights [Potential diagnosis of specific phobias (arachnophobia and acrophobia) assessed by application of the Diagnostic Short-Interview for Mental Disorders (Mini-Dips)].

Exclusion Criteria:

  • Any acute or chronic mental and / or somatic disease
  • Psychological, psychiatric, neurological or pharmacological treatment (Application of the Mini-DIPS to screen for the presence of a psychological condition)
  • Drug or alcohol abuse
  • Pregnancy

Sites / Locations

  • Mental Health Research and Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exposure

No Exposure

Arm Description

Participants of this arm receive one 120-minute session of exposure treatment for spider fear.

Participants of this arm receive no exposure or other adequate treatment.

Outcomes

Primary Outcome Measures

Behavioral Approach Test (BAT) for Spiders
Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus) [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. During the Behavioral Approach Test (BAT) the closest distance to a spider as well as subjective fear and heart rate is measured.
Behavioral Approach Test (BAT) for Heights
Change in the Behavioral Approach Test with heights (untreated fear stimulus) [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. During the Behavioral Approach Test (BAT) the level of the approached height as well as subjective fear and heart rate is measured.

Secondary Outcome Measures

Fear of Spiders Questionnaire (FSQ)
Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of spiders will be used. The Fear of Spiders Questionnaire (FSQ) will be applied. Scores on this scale range from 0 to 108, with higher scores indicating greater fear of spiders.
Spider Fear Questionnaire (SPQ)
Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of spiders will be used. The Spider Fear Questionnaire (SPQ) will be applied. Scores on this scale range from 0 to 31, with higher scores indicating greater fear of spiders.
Spider Beliefs Questionnaire (SBQ)
Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of spiders will be used. The Spider Beliefs Questionnaire (SBQ) will be applied. Scores on this scale range from 0 to 100, with higher scores indicating greater fear of spiders.
Acrophobia Questionnaire (AQ)
Change in the height related questionnaire [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of heights will be used. The German version of the anxiety subscale of the Acrophobia Questionnaire (AQ) will be used. Scores on these scales range from 0 to 120, with higher scores indicating greater fear of heights.

Full Information

First Posted
March 28, 2019
Last Updated
March 28, 2023
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT03907345
Brief Title
Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure
Official Title
Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study investigates whether a one-session exposure treatment for spider-related stimuli can lead to a generalization of extinguished fear to height-related stimuli in individuals with comorbid fear of spiders and fear of heights.
Detailed Description
Exposure therapy has been proven to be effective in the treatment of specific phobias and in a variety of fear evoking situations and stimuli. However, since there is a high prevalence of comorbid fears, therapeutic interventions can get very extensive when each fearful situation and / or stimuli needs to be treated separately and over a repeated number of times. It has recently been shown, that exposure to one fearful stimuli (i.e., a spider), can also lead to a reduction of fear to another, perceptually and conceptually related, but untreated fearful stimulus (i.e., a cockroach) (Preusser, Margraf & Zlomuzica, 2017). Potentially, this generalization of exposure effects might also be relevant for coexisting fears that do not share conceptually related fearful stimuli (e.g., fear of spiders and fear of heights). The present study aims to investigate whether successful exposure treatment to one fearful stimulus (i.e., a spider) can also lead to a reduction of fear to an untreated fear evoking stimulus (i.e., height). Participants will be randomly assigned to the treatment or no-treatment condition. The entire experimental procedure will take place in three sessions. The first session incorporates spider and height fear related questionnaires and two Behavioral Approach Tests (BATs): One that involves a spider and one that involves height. These BATs are counterbalanced in each group with half of participants receiving the spider BAT first and the height BAT second, and vice versa. The second session takes place approximately seven days later. The treatment group receives a seven-step in vivo exposure with spiders (duration: 1,5 hours). Twenty-four hours later, session 3 takes place and involves the same measures that were applied in session 1. The treatment and no-treatment group receive an identical set of measures except that the no-treatment group will not be subjected to exposure. The effects of exposure-based anxiety reductions toward spiders (treated fear stimulus) and heights (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the behavioral and subjective level at pretreatment and posttreatment (24 hours after exposure).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear of Spiders, Fear of Heights
Keywords
Exposure Therapy, Fear of Spiders, Fear of Heights, Anxiety Disorders, Generalization, Extinction, Specific Phobias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure
Arm Type
Experimental
Arm Description
Participants of this arm receive one 120-minute session of exposure treatment for spider fear.
Arm Title
No Exposure
Arm Type
No Intervention
Arm Description
Participants of this arm receive no exposure or other adequate treatment.
Intervention Type
Behavioral
Intervention Name(s)
Exposure
Intervention Description
The exposure session comprises a hierarchy of 7 steps, reaching from (1) holding a glass with the spider 30cm in from the body / face, to (7) letting the spider walk on the arm. The exposure session has a duration of 120 minutes. Prior to the exposure, participants receive psychoeducation on anxiety and phobias. A house spider (Tegenaria domestica) is used for the exposure.
Primary Outcome Measure Information:
Title
Behavioral Approach Test (BAT) for Spiders
Description
Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus) [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. During the Behavioral Approach Test (BAT) the closest distance to a spider as well as subjective fear and heart rate is measured.
Time Frame
Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Title
Behavioral Approach Test (BAT) for Heights
Description
Change in the Behavioral Approach Test with heights (untreated fear stimulus) [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. During the Behavioral Approach Test (BAT) the level of the approached height as well as subjective fear and heart rate is measured.
Time Frame
Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Secondary Outcome Measure Information:
Title
Fear of Spiders Questionnaire (FSQ)
Description
Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of spiders will be used. The Fear of Spiders Questionnaire (FSQ) will be applied. Scores on this scale range from 0 to 108, with higher scores indicating greater fear of spiders.
Time Frame
Change in FSQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Title
Spider Fear Questionnaire (SPQ)
Description
Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of spiders will be used. The Spider Fear Questionnaire (SPQ) will be applied. Scores on this scale range from 0 to 31, with higher scores indicating greater fear of spiders.
Time Frame
Change in SPQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Title
Spider Beliefs Questionnaire (SBQ)
Description
Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of spiders will be used. The Spider Beliefs Questionnaire (SBQ) will be applied. Scores on this scale range from 0 to 100, with higher scores indicating greater fear of spiders.
Time Frame
Change in SBQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Title
Acrophobia Questionnaire (AQ)
Description
Change in the height related questionnaire [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)]. Self-report questionnaires assessing fear of heights will be used. The German version of the anxiety subscale of the Acrophobia Questionnaire (AQ) will be used. Scores on these scales range from 0 to 120, with higher scores indicating greater fear of heights.
Time Frame
Change in AQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Other Pre-specified Outcome Measures:
Title
Fear and Disgust Rating
Description
Self-developed, computerized fear and disgust ratings of 30 pictures of various animals (i.e., different mammals, insects, rodents, reptiles, birds). Participants have to rate their level of fear and disgust for each animal separately on a scale from 0 to 100. Higher scores indicate greater fear and disgust for each animal.
Time Frame
Change in Fear and Disgust Rating from pre- to posttreatment (across one week from pretreatment to posttreatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Comorbid presence of fear of spiders and fear of heights [Potential diagnosis of specific phobias (arachnophobia and acrophobia) assessed by application of the Diagnostic Short-Interview for Mental Disorders (Mini-Dips)]. Exclusion Criteria: Any acute or chronic mental and / or somatic disease Psychological, psychiatric, neurological or pharmacological treatment (Application of the Mini-DIPS to screen for the presence of a psychological condition) Drug or alcohol abuse Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Zlomuzica, PhD
Organizational Affiliation
Ruhr-University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Research and Treatment Center
City
Bochum
ZIP/Postal Code
44787
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28589965
Citation
Preusser F, Margraf J, Zlomuzica A. Generalization of Extinguished Fear to Untreated Fear Stimuli after Exposure. Neuropsychopharmacology. 2017 Dec;42(13):2545-2552. doi: 10.1038/npp.2017.119. Epub 2017 Jun 7.
Results Reference
background
Citation
Margraf, J. & Cwik, J. C. (2017). Mini-DIPS Open Access: Diagnostic Short-Interview for Mental Disorders. [Mini-DIPS Open Access: Diagnostisches Kurzinterview bei psychischen Störungen]. Bochum: Forschungs- und Behandlungszentrum für psychische Gesundheit, Ruhr-Universität. doi:10.13154/rub.102.9
Results Reference
background

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Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure

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