Virtual Reality Exposure Therapy in Agoraphobic Participants

Panic Disorder Clinical Trial

Official title:

Virtual Reality Exposure Therapy in Agoraphobic Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734370
• Other study ID #: KP-2008-518
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Agoraphobia
• Panic Disorder

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