Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000959279
Ethics application status
Not yet submitted
Date submitted
4/11/2009
Date registered
6/11/2009
Date last updated
6/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Reality Exposure Therapy for Agoraphobia
Scientific title
Virtual Reality Exposure Therapy for Agoraphobia involving a cognitive component: a comparative trial
Universal Trial Number (UTN)
U1111-1112-3836
Trial acronym
VR Agora
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agoraphobia 252122 0
Condition category
Condition code
Mental Health 252326 252326 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment of agoraphobia by using virtual reality exposure and cognitive therapy. Virtual reality exposure involves the confrontation of the agoraphobics with 3D real time computerized phobogenic situations. Cognitive therapy implies the use of cognitive therapy techniques (cognitive restructuring). Both are administered by a PhD student in clinical psychology.
Protocol :
1 weekly session of 1 and a half hour for 2 and a half month (total 10 sessions : 2 of cognitive and 8 of virtual reality exposure)
Intervention code [1] 241502 0
Treatment: Other
Comparator / control treatment
Virtual reality exposure therapy alone.
Protocol :
1 weekly session of 1 and a half hour for 2 and a half month (total 10 sessions : 2 of neutral conversation and 8 of virtual reality exposure).
Control group
Active

Outcomes
Primary outcome [1] 253194 0
Anxiety Sensitivity Index ASI (Peterson 1993). This instrument is a 16-item questionnaire which rate the fear of anxiety-related symptoms
Timepoint [1] 253194 0
At Baseline, after last therapeutic session and 6 months Follow Up
Primary outcome [2] 253195 0
Agoraphobia cognitions questionnaire ACQ (Chambless 1984) is 5 points scale questionnaires comprising 14 items to rate the intensity of thoughts regarding agoraphobia cognitions.
Timepoint [2] 253195 0
At Baseline, after last therapeutic session and 6 months Follow Up
Primary outcome [3] 253196 0
Mobility inventory for agoraphobia MIA, part 1 (Chambless 1985). This a 5 point Likert scale rating the severity of behavioural avoidance of situations dreaded by the agoraphobics
Timepoint [3] 253196 0
At Baseline, after last therapeutic session and 6 months Follow Up
Primary outcome [4] 253197 0
Behavioral Avoidance Test BAT. Classic objective behavioural measures of phobia intensity and clinical progress.
Timepoint [4] 253197 0
At Baseline, after last therapeutic session and 6 months Follow Up
Secondary outcome [1] 262129 0
Depression Anxiety Stress Scales DASS 21 (Lovibond 1995) is a 21-items subjective questionnaire that uses a 4 point scale to measure mood and depressive symptoms, anxiety and stress
Timepoint [1] 262129 0
At Baseline, after last therapeutic session and 6 months Follow Up

Eligibility
Key inclusion criteria
Diagnosis of Agoraphobia with or without Panic disorder
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy, epilepsy, severe organic condition, Heart arrhythmia, vestibular syndrome, substance abuse, discontinuation in the psychiatric treatment, psychosis (schizoid or not schizoid) and absence of competence in use of English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through different and various means.Diagnosis procedure will involve experienced post graduate psychology students under the supervision of a Clinic Director. Following the diagnosis, Allocation concealment will be achieved by using sealed opaque envelopes addressed to the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participants will be characterized by a specific number and this code will be feed in a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2208 0
2109

Funding & Sponsors
Funding source category [1] 243976 0
University
Name [1] 243976 0
Macquarie University
Country [1] 243976 0
Australia
Primary sponsor type
University
Name
Macquarie University (Psychology Dpt)
Address
Psychology department
Macquarie University
North Ryde
NSW 2109
Australia
Country
Australia
Secondary sponsor category [1] 251327 0
None
Name [1] 251327 0
Address [1] 251327 0
Country [1] 251327 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 244085 0
Macquarie University Ethics Review Committee
Ethics committee address [1] 244085 0
Macquarie University Ethics Review Committee
Research Office
Level 3, Research HUB, Building C5C, Macquarie University, NSW 2109.
Ethics committee country [1] 244085 0
Australia
Date submitted for ethics approval [1] 244085 0
20/11/2009
Approval date [1] 244085 0
Ethics approval number [1] 244085 0

Summary
Brief summary
Agoraphobia, a quite common anxiety disorder in Australia, is defined as the fear of being in places or situations from which escape might be difficult or embarrassing. Standard exposure therapy is not bereft of weaknesses. Hence, new research lines study the virtual reality exposure therapy. Virtual reality allows patients to interact in real time 3D computerized worlds. The project will include a sample of volunteered patients suffering from agoraphobia who will be exposed to virtual environments specifically created for the present study using an affordable game editor. This collaborative effort’s goal is finally to search for a better understanding of agoraphobia innovative treatment and to discover presence objective measure instruments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30462 0
Address 30462 0
Country 30462 0
Phone 30462 0
Fax 30462 0
Email 30462 0
Contact person for public queries
Name 13709 0
Dr Eric Malbos
Address 13709 0
Dept. of Psychology, Building C3A, Room 709
Macquarie University, Sydney, NSW 2109, Australia.
Country 13709 0
Australia
Phone 13709 0
+61 2 9850 8053
Fax 13709 0
+61 2 9850 8062
Email 13709 0
[email protected]
Contact person for scientific queries
Name 4637 0
Dr Eric Malbos
Address 4637 0
Dept. of Psychology, Building C3A, Room 709
Macquarie University, Sydney, NSW 2109, Australia.
Country 4637 0
Australia
Phone 4637 0
+61 2 9850 8053
Fax 4637 0
+61 2 9850 8062
Email 4637 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.