NCT01442805

Brief Summary

The project aims to explore the potential of Virtual Reality Exposure Therapy (VRET) for the treatment of the fear of driving, the fear of flying and the fear of public speaking. The study is a randomized controlled trial (RCT) designed to compare the efficiency of cognitive behavioural therapy with exposures in imagination to behavioural therapy with exposures in virtual reality. Anxiety levels are measured using specific questionnaires, SUD ratings and physiological measures (heart rate, skin conductance, skin temperature, breathing frequency, heart rate variability). Hypothesis: Treatments with exposures in virtual reality are more efficient than treatments with exposures in imagination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

September 15, 2011

Last Update Submit

March 13, 2017

Conditions

Keywords

Cognitive Behavior TherapyVirtual Reality Exposure TherapyPsychophysiological MeasuresDriving PhobiaFlying Phobia

Outcome Measures

Primary Outcomes (1)

  • Flight taken

    Participants are expected to take a real flight

    6 months

Secondary Outcomes (2)

  • Physiological Measures

    6 months

  • Specific Questionnaires

    6 months

Study Arms (2)

RV

EXPERIMENTAL

Cognitive Behavioral Therapy with Virtual Reality Exposures

Behavioral: Virtual Reality Exposure Therapy

IMAGO

EXPERIMENTAL

Cognitive Behavioral Therapy with Exposure Therapy through Imagination

Behavioral: Exposure Therapy through Imagination

Interventions

Participants are exposed to the feared situation (flying) through the virtual reality technology

RV

Participants are exposed to the feared situation (flying) through exposure technique of imagination.

IMAGO

Eligibility Criteria

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

You may qualify if:

  • Confirmed diagnosis of a specific phobia (DSM-IV-TR)

You may not qualify if:

  • Pregnant women
  • Subjects with severe pulmonary / cardiovascular problems; Asthma, epilepsy, vertigo
  • Drug abuse
  • Subjects under on-stabilized anti-depressant treatment
  • Psychotic subjects
  • Subjects with suicidal ideas
  • Subjects presenting insufficient intellectual capabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche Public de la Santé

Strassen, L-1445, Luxembourg

Location

MeSH Terms

Conditions

Aerophobia

Interventions

Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Charles Pull, Prof.Dr.

    Centre de Recherche Public de la Santé

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 29, 2011

Study Start

October 1, 2008

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

March 15, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations