Clinical trial NCT01746667: Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Social Phobia
Keywords: Social Anxiety Disorder
Social Phobia
Virtual Reality
Exposure
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline: Liebowitz Social Anxiety Scale-Self report
timeFrame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
measure: Change from baseline: Fear of Negative Evaluation Scale
timeFrame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Secondary outcomes:
measure: Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale
timeFrame: Pre-treatment to post-treatment (5 weeks)
measure: Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module)
timeFrame: Pre-treatment to three months follow-up.
measure: Change from baseline: Depression Anxiety Stress Scale
timeFrame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
measure: Change from baseline: Personality Disorder Belief Questionnaire
timeFrame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
measure: Change from baseline: Eurohis Quality of Life Scale
timeFrame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Other outcomes:
measure: Change from baseline and in-treatment change: Focus of Attention Questionnaire
timeFrame: Pre-treatment to post-treatment (5 weeks), change during the course of four weeks of exposure therapy (session 3 until 9)
measure: In-treatment change: Social Phobia Weekly Summary Scale
timeFrame: Change from session to session during the course of five weeks (i.e., session 1 until 10)
measure: Change from baseline:Social Cost Questionnaire
timeFrame: Pre-treatment to session 7 (3,5 weeks) and post-treatment (5 weeks)
measure: Experiences in Close Relationships Questionnaire
timeFrame: Pre-treatment
measure: In treatment change: Self-efficacy for Social Situations
timeFrame: Change from session to session during the course of five weeks (i.e., session 1 until 10)
measure: In-treatment change: Working Alliance Inventory -Short Revised
timeFrame: Session 3 to session 6 (two weeks)
measure: Simulator Sickness Questionnaire
timeFrame: Session 2 (first week of treatment)
measure: Credibility and Expectancy Questionnaire
timeFrame: Session 3 (second week of treatment)
measure: In-treatment change: Ingroup Presence Questionnaire
timeFrame: Session 2 to session 3 (one week) and session and 6 (three weeks).
measure: Change from baseline: Dot-Probe Task
timeFrame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
measure: Change from baseline: Approach Avoidance Task
timeFrame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Locations:
city: Amsterdam
country: Netherlands
facility: University of Amsterdam, Department of Clinical Psychology
Study officials:
affiliation: University of Amsterdam
name: Paul GM Emmelkamp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Amsterdam
name: Nexhmedin Morina, PhD
role: STUDY_DIRECTOR
References:
citation: Kampmann IL, Emmelkamp PMG, Morina N. Cognitive predictors of treatment outcome for exposure therapy: do changes in self-efficacy, self-focused attention, and estimated social costs predict symptom improvement in social anxiety disorder? BMC Psychiatry. 2019 Feb 22;19(1):80. doi: 10.1186/s12888-019-2054-2.