NCT03907345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

3.3 years

First QC Date

March 28, 2019

Last Update Submit

March 28, 2023

Conditions

Keywords

Exposure TherapyFear of SpidersFear of HeightsAnxiety DisordersGeneralizationExtinctionSpecific Phobias

Outcome Measures

Primary Outcomes (2)

  • 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.

    Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)

  • 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.

    Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)

Secondary Outcomes (4)

  • Fear of Spiders Questionnaire (FSQ)

    Change in FSQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)

  • Spider Fear Questionnaire (SPQ)

    Change in SPQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)

  • Spider Beliefs Questionnaire (SBQ)

    Change in SBQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)

  • Acrophobia Questionnaire (AQ)

    Change in AQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)

Other Outcomes (1)

  • Fear and Disgust Rating

    Change in Fear and Disgust Rating from pre- to posttreatment (across one week from pretreatment to posttreatment)

Study Arms (2)

Exposure

EXPERIMENTAL

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

Behavioral: Exposure

No Exposure

NO INTERVENTION

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

Interventions

ExposureBEHAVIORAL

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.

Exposure

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Research and Treatment Center

Bochum, 44787, Germany

Location

Related Publications (2)

  • 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.

    PMID: 28589965BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

ArachnophobiaAcrophobiaAnxiety DisordersPhobia, Specific

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Armin Zlomuzica, PhD

    Ruhr-University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 8, 2019

Study Start

June 6, 2019

Primary Completion

October 7, 2022

Study Completion

October 7, 2022

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations