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Completed

NCT Number: NCT01746667

Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders Social Phobia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Amsterdam, Department of Clinical Psychology

Amsterdam, 1018 XA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure in vivo

Behavioral

Other names: Behavior Therapy

virtual reality exposure therapy

Behavioral

Other names: Virtual Reality Therapy

Primary outcomes

  1. Change from baseline: Liebowitz Social Anxiety Scale-Self report

    Time frame: Pre-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.

  2. Change from baseline: Fear of Negative Evaluation Scale

    Time frame: Pre-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 outcomes

  1. Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale

    Time frame: Pre-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.

  2. Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module)

    Time frame: Pre-treatment to three months follow-up.

    Change in diagnosis of Social Phobia from pre-treatment to three months follow-up.

  3. Change from baseline: Depression Anxiety Stress Scale

    Time frame: Pre-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.

  4. Change from baseline: Personality Disorder Belief Questionnaire

    Time frame: Pre-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.

  5. Change from baseline: Eurohis Quality of Life Scale

    Time frame: Pre-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.

Other outcomes

  1. Change from baseline and in-treatment change: Focus of Attention Questionnaire

    Time frame: Pre-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.

  2. In-treatment change: Social Phobia Weekly Summary Scale

    Time frame: Change 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.

  3. Change from baseline:Social Cost Questionnaire

    Time frame: Pre-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).

  4. Experiences in Close Relationships Questionnaire

    Time frame: Pre-treatment

  5. In treatment change: Self-efficacy for Social Situations

    Time frame: Change 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).

  6. In-treatment change: Working Alliance Inventory -Short Revised

    Time frame: Session 3 to session 6 (two weeks)

    Change during treatment (with an expected average of two weeks) will be assessed.

  7. Simulator Sickness Questionnaire

    Time frame: Session 2 (first week of treatment)

    This scale will be used in the Virtual Reality condition only

  8. Credibility and Expectancy Questionnaire

    Time frame: Session 3 (second week of treatment)

  9. In-treatment change: Ingroup Presence Questionnaire

    Time frame: Session 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).

  10. Change from baseline: Dot-Probe Task

    Time frame: Pre-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.

  11. Change from baseline: Approach Avoidance Task

    Time frame: Pre-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.

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2012
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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