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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00734370
Other study ID # KP-2008-518
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2008
Est. completion date January 2012

Study information

Verified date September 2018
Source VU University of Amsterdam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. enhanced VRET making use of the latest avatar technology with

2. exposure in vivo in agoraphobic participants

3. wait-list control.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date January 2012
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Reality Exposure Therapy for agoraphobic participants
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
Standard exposure in vivo for agoraphobic participants
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)

Locations

Country Name City State
Netherlands University of Amsterdam Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 same measures will also be taken at 6 months follow-up. 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
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