NCT00734370

Brief Summary

Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders, particularly for specific phobias as fear of heights and fear of flying (e.g. Powers \& Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable. Therefore, the aim of the present research proposal is to investigate the comparative efficacy of:

  1. 1.enhanced VRET making use of the latest avatar technology with
  2. 2.exposure in vivo in agoraphobic participants
  3. 3.wait-list control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

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

First Submitted

Initial submission to the registry

August 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

August 11, 2008

Last Update Submit

September 11, 2018

Conditions

Keywords

Panic Disorder and AgoraphobiaVirtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (1)

  • Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT)

    Assessed at pre- and post-treatment and 6-12 months follow-up

Secondary Outcomes (1)

  • Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Panic Disorder Severity Scale (PDSS); Agoraphobic Cognitions Questionnaire (ACQ); Bodily Sensations Questionnaire (BSQ); Panic Appraisal Inventory (PAI)

    Process measures: are taken prior to treatment, after the fourth treatment session and at post-treatment. The PDSS and PAI will be administered every therapy session

Study Arms (3)

VRET

EXPERIMENTAL

Virtual Reality Exposure Therapy for agoraphobic participants

Behavioral: Virtual Reality Exposure Therapy for agoraphobic participants

Exposure in vivo

ACTIVE COMPARATOR

Standard exposure in vivo for panic disorder

Behavioral: Standard exposure in vivo for agoraphobic participants

Wait-list control

NO INTERVENTION

Wait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting.

Interventions

This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of * Psycho-education, breathing training and cognitive restructuring * Virtual reality Exposure to agoraphobic situations and interoceptive exposure * Relapse prevention

VRET

This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of * Psycho-education, breathing training and cognitive restructuring * Standard exposure in vivo to agoraphobic situations and interoceptive exposure * Relapse prevention (according to the protocol of Craske \& Barlow)

Exposure in vivo

Eligibility Criteria

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

You may qualify if:

  • A full diagnosis of panic disorder with agoraphobia according to the DSM-IV
  • Between the ages of 18-65 years
  • Sufficient fluency in Dutch to complete treatment and research protocol

You may not qualify if:

  • Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, pacemaker)
  • Current use of Beta-blockers
  • Current use of tranquilizers (Benzodiazepines)
  • Unstable psychotropic medication
  • Substance dependence
  • Psychosis
  • Depression with suicidal ideation
  • Posttraumatic Stress Disorder
  • Dementia or other severe cognitive impairment
  • Bipolar Disorder
  • Borderline Personality Disorder
  • Anti-social Personality Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Amsterdam

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Panic DisorderAgoraphobia

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Paul MG Emmelkamp, Professor

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 14, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2011

Study Completion

January 1, 2012

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations