NCT03012035

Brief Summary

This study evaluates the role of treatment success expectation in spider fearful individuals on the actual treatment success. Half of participants will have positive treatment success expectations, while the other half will have neutral treatment outcome expectations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 18, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

December 21, 2016

Last Update Submit

March 20, 2018

Conditions

Keywords

psychotherapyexpositionspider fearexpectation

Outcome Measures

Primary Outcomes (1)

  • Change in subjective anxiety assessed by questionnaire

    assessment of change in subjective anxiety by questionnaire at selcted time points

    Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days

Study Arms (2)

experimental group

EXPERIMENTAL

Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).

Other: positive treatment expectations

comparator group

OTHER

The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).

Other: neutral treatment expectations

Interventions

Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).

experimental group

The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).

comparator group

Eligibility Criteria

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

You may qualify if:

  • good knowledge of German language
  • marked fear or anxiety about spiders
  • spiders almost always provoke immediate fear or anxiety
  • spiders are actively avoided or endured with intense fear or anxiety
  • the fear or anxiety is out of proportion to the actual danger posed by spiders
  • the fear, anxiety, or avoidance is persistent, typically lasting for 6 months or more
  • the disturbance is not better explained by the symptoms of mental disorders as agoraphobia, obsessive-compulsive disorder, posttraumatic stress disorder, separation anxiety or social anxiety disorder

You may not qualify if:

  • acute or chronic psychiatric disorder
  • currently in psychological or psychiatric treatment
  • knowledge of exposure training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy University of Basel

Basel, 4055, Switzerland

Location

MeSH Terms

Conditions

Phobic DisordersArachnophobia

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Jens Gaab, Prof. Dr.

    Department of Clinical Psychology and Psychotherapy University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 6, 2017

Study Start

May 18, 2017

Primary Completion

March 12, 2018

Study Completion

March 12, 2018

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations