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Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01746667
Enrollment
70
Registered
2012-12-11
Start date
2012-02-29
Completion date
2015-08-31
Last updated
2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder, Social Phobia

Keywords

Social Anxiety Disorder, Social Phobia, Virtual Reality, Exposure

Brief summary

The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. Levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.

Interventions

BEHAVIORALVirtual Reality Exposure Therapy

Sponsors

VU University of Amsterdam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 18 - 65 years old * a primary diagnosis of social anxiety disorder as measured with the SCID * fluency in Dutch.

Exclusion criteria

* psychotic episodes in the past, suicidal intentions or substance dependence. * behavior therapy in the preceding one year.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline: Fear of Negative Evaluation ScalePre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Change from baseline: Liebowitz Social Anxiety Scale-Self reportPre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

Secondary

MeasureTime frameDescription
Change from baseline: Depression Anxiety Stress ScalePre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Change from baseline: Personality Disorder Belief QuestionnairePre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Change from baseline: Eurohis Quality of Life ScalePre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance ScalePre-treatment to post-treatment (5 weeks)The BAT consists of a videotaped 5 minute impromptu speech in front of two confederates. The Public Speaking Performance Scale will be used to evaluate the performance during the speech, both by patients and indipendent raters. Change from pre-treatment to post-treatment (5 weeks) will be examined.
Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module)Pre-treatment to three months follow-up.Change in diagnosis of Social Phobia from pre-treatment to three months follow-up.

Other

MeasureTime frameDescription
Change from baseline:Social Cost QuestionnairePre-treatment to session 7 (3,5 weeks) and post-treatment (5 weeks)Change from pre-treatment to sessino 7 (3,5 weeks) and to post-treatment (5 weeks).
Experiences in Close Relationships QuestionnairePre-treatment
In treatment change: Self-efficacy for Social SituationsChange from session to session during the course of five weeks (i.e., session 1 until 10)Self-efficacy will be used in each session during the course the treatment that will take place twice a week (session 1 until 10). Change during treatment will be assessed (5 weeks).
In-treatment change: Working Alliance Inventory -Short RevisedSession 3 to session 6 (two weeks)Change during treatment (with an expected average of two weeks) will be assessed.
Simulator Sickness QuestionnaireSession 2 (first week of treatment)This scale will be used in the Virtual Reality condition only
Credibility and Expectancy QuestionnaireSession 3 (second week of treatment)
In-treatment change: Ingroup Presence QuestionnaireSession 2 to session 3 (one week) and session and 6 (three weeks).This scale will be used in the Virtual Reality condition only to measure change in the sense of presence from session 2 to session 3 (one week) and session 6 (three weeks).
Change from baseline: Dot-Probe TaskPre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.An implicit measure to assess attentional bias in social phobia. Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Change from baseline: Approach Avoidance TaskPre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.A computer task to assess automatic approach and avoidance tendencies by measuring reaction times for pushing away or pulling closer faces with a joystick. Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
In-treatment change: Social Phobia Weekly Summary ScaleChange from session to session during the course of five weeks (i.e., session 1 until 10)The Social Phobia Weekly Summary Scale will be used in each session during the course of the treatment that will take place twice a week (session 1 until 10). Change during treatment will be assessed.
Change from baseline and in-treatment change: Focus of Attention QuestionnairePre-treatment to post-treatment (5 weeks), change during the course of four weeks of exposure therapy (session 3 until 9)Focus of Attention will be assessed during the course of four weeks of exposure therapy that will take place twice a week (session 3 until 9). Change from pre-treatment to post-treatment (5 weeks) as well as change during treatment (four weeks) will be assessed.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026