Condition category
Mental and Behavioural Disorders
Date applied
18/08/2010
Date assigned
23/09/2010
Last edited
23/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephane Bouchard

ORCID ID

Contact details

Université du Québec en Outaouais
Dept. de Psychoéducation et de psychologie
CP 1250
Succ Hull
Quebec
Gatineau
J8X 3X7
Canada
+1 819 595 3900/2360
stephane.bouchard@uqo.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A comparative study of virtual reality versus in vivo exposure in the cognitive behavior treatment of social phobia

Acronym

VRCVB

Study hypothesis

1. Aims:
1.1. To compare Cognitive Behaviour Therapy (CBT) treatments that differ only by the use of exposure in vivo or in virtuo and a waiting list control condition
1.2. To explore the efficacy of a combined Virtual Reality (VR) and in vivo treatment

2. Hypotheses:
2.1 Both non-combined treatments would be superior to the waiting list
2.2. The combined treatment would be more effective than the other two treatments

Ethics approval

The local ethics committee (Comité d'Éthique de la Recherche of the Université du Quebec en Outaouais) approved on the 7th of October 2009 (ref: 807). Ethics approval is due for renewal on the 7th of October 2010

Study design

3 arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet [in French]

Condition

Social phobia

Intervention

After receiving an appropriate diagnosis and completing the ethics procedures, participants will be randomly assigned to one of the following three conditions:
1. Tradd-CBT: Traditional individual CBT with in vivo exposure
2. VR-CBT: Traditional individual CBT with in virtuo exposure
3. Control: Waiting list to be treated later with a combined Tradd- and VR-CBT treatment

For in Tradd-CBT condition, the therapy will be similar to what is being used in other research centers, with treatment beginning by a case conceptualization, followed by cognitive restructuring, in vivo exposure (in real-life situations outside the therapist’s office) and relapse prevention. The only difference between Tradd-CBT and VR-CBT will be the use of four VR scenarios to conduct in virtuo exposure: speaking at a meeting, introducing oneself to new people, engaging in conversations in a restaurant and asserting oneself. There won’t be any in vivo exposure exercise in the VR-CBT. All treatments will last 14 sessions and will be supervised by the principal investigator (SB).
The treatment will be delivered by graduate students experienced in CBT and the treatment of anxiety disorders. The therapists also possesses a full year of practical experience in using VR in CBT. The in virtuo exposure scenarios will be produced by an IBM computer (Pentium III, 4.2Ghz, 1 Go RAM) equipped with a nVIDIA Gforce Ti 4200 graphics card, an InertiaCube motion tracker from Intersense, an nVISOR head mounted display by nVIS and a wireless mouse by Gyration.

A standardized treatment will be conducted for 14 weekly 60-minutes sessions delivered by experienced therapists. Treatment differentiation will be enhanced by the use of treatment manuals while treatment fidelity will be maximize by weekly supervisions. Adherence to the research protocol (treatment differentiation and fidelity) will be assessed regularly by independent raters who will review videotapes of therapy sessions.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Liebowitz Social Anxiety Scale (LSAS)
It is a self-report consisting of 24 items that has been used in most of the recent outcome studies on SAD. Eleven items correspond to fear and avoidance of social interactions and 13 to performance fears. It is an excellent measure of SAD symptoms. Participant anxiety and avoidance are assessed. A total score is obtained, as well as fear and avoidance subscores.

All outcomes will be assessed at baseline, post-treatment at at 6 month follow up.

Secondary outcome measures

1. Rathus Assertiveness Schedule
This self-report measures social assertiveness. Thirty items, under the form of assertions concerning the way of behaving in different social situations, are proposed. The subject must indicate to which degree these assertions are typical of him/her and select one of the six possible answers ranging from +3 (really typical) to –3 (really not typical).
2. Questionnaire on Social Contexts Inducing Anxiety
This questionnaire enables to establish a typology of social anxieties (focused or generalized phobia, and type of subgroup: performance, assertiveness, intimacy or scrutiny anxiety) where the participant assesses the degree of her/his anxiety.
3. Behavior Avoidance Test
Participants have to give an impromptu speech to a small audience (video recorded), for 6 minutes. Heart-rate variability and subjective anxiety are recorded and behavioral manifestations are coded by three independent assessors 'blind' to the hypotheses of the study.

All outcomes will be assessed at baseline, post-treatment at at 6 month follow up.

Overall trial start date

18/09/2010

Overall trial end date

18/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ambulatory men and women
2. At least 18 years old and at most 65 years old
3. French speaking
4. Receiving a principal diagnosis of social anxiety disorder (SAD) according to DSM-IV-TR’s diagnostic criteria. Assessed at a psychiatric interview, standardized with the Structured Clinical Interview for DSM (SCID)
5. Suffering from SAD since at least two years
6. If currently taking medication for SAD, pharmacotherapy must be stabilized (same type and dosage) for at least six months and the social phobia remained stable and uncured (i.e., still meeting diagnostic criteria despite take the medication)
Note that there is no perfect solution to the problem of medication since most severe cases already receive Selective Serotonin Reuptake Inhibitor (SSRI) from their doctors when they seek psychological treatments (thus, recruiting non-medicated participants would threaten the feasibility of the study and could lead to the selection of less severe cases) and stopping medication would induce other methodological problems (e.g., withdrawal symptoms, artificial peak of severity at pre-treatment, ethical issues).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45 (15 per group)

Participant exclusion criteria

1. Currently suffering from a severe organic disease, dementia, mental retardation, schizophrenia, amnesia, psychosis or bipolar disorder
2. The SAD being secondary to any DSM-IV Axis-III diagnosis
3. Receiving any form of concurrent psychotherapy

Recruitment start date

18/09/2010

Recruitment end date

18/08/2011

Locations

Countries of recruitment

Canada

Trial participating centre

Université du Québec en Outaouais
Gatineau
J8X 3X7
Canada

Sponsor information

Organisation

Social Sciences and Humanities Research Council (Canada)

Sponsor details

350 Albert Street
P.O. Box 1610
Ottawa
K1P 6G4
Canada
+1 613 992 3145
patricia.emery@sshrc-crsh.gc.ca

Sponsor type

Research council

Website

http://www.sshrc-crsh.gc.ca/home-accueil-eng.aspx

Funders

Funder type

Research council

Funder name

Social Sciences and Humanities Research Council (Canada) (Project: 7032024)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes