NCT03031002

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

January 14, 2017

Last Update Submit

January 24, 2017

Conditions

Keywords

exposurespider phobiageneralizationextinction

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)

Secondary Outcomes (5)

  • Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)

    Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)

  • Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment

    Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)

  • Change in the Fear of Spiders Questionnaire (FSQ)

    Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)

  • Change in the Spider Phobia Questionnaire (SPQ)

    Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)

  • Change in the Spider Beliefs Questionnaire (SBQ)

    Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)

Other Outcomes (3)

  • Epigenetic / DNA methylation

    Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)

  • Depression Anxiety Stress Scales (DASS)

    Pretreatment (assessed once prior to treatment)

  • Questionnaire for the Assessment of Disgust Sensitivity (FEE)

    Pretreatment (assessed once prior to treatment)

Study Arms (2)

Exposure Treatment

EXPERIMENTAL

Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear

Behavioral: Exposure treatment for spider fear

No Exposure Treatment

NO INTERVENTION

Participants of this arm receive no exposure or other adequate treatment

Interventions

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.

Exposure Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spider phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria

You may not qualify if:

  • any neurological or neuropsychiatric condition
  • current behavioral or pharmacological treatment
  • any mental disorder that is considered more severe than specific phobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Phobia, SpecificArachnophobia

Study Officials

  • Armin Zlomuzica, Dr.

    Ruhr University of Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 25, 2017

Study Start

February 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share