Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

NCT01746667 | Completed

• 1 other identifier: 05510207
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder; Social Phobia

Keywords

Social Anxiety Disorder; Social Phobia; Virtual Reality; Exposure

Outcome Measures

Primary Outcomes (2)

• Change from baseline: Liebowitz Social Anxiety Scale-Self report

  Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

  Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.

• Change from baseline: Fear of Negative Evaluation Scale

  Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

  Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.

Secondary Outcomes (5)

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

  Pre-treatment to post-treatment (5 weeks)

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

  Pre-treatment to three months follow-up.

• Change from baseline: Depression Anxiety Stress Scale

  Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.

• Change from baseline: Personality Disorder Belief Questionnaire

  Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.

• Change from baseline: Eurohis Quality of Life Scale

  Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.

Other Outcomes (11)

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

  Pre-treatment to post-treatment (5 weeks), change during the course of four weeks of exposure therapy (session 3 until 9)

• In-treatment change: Social Phobia Weekly Summary Scale

  Change from session to session during the course of five weeks (i.e., session 1 until 10)

• Change from baseline:Social Cost Questionnaire

  Pre-treatment to session 7 (3,5 weeks) and post-treatment (5 weeks)

Study Arms (3)

Exposure in vivo

EXPERIMENTAL

This treatment will consist of 10 sessions (twice a week) of exposure therapy based on the protocol used previously in exposure therapy for social anxiety disorder by Scholing \& Emmelkamp (1993).

Behavioral: Exposure in vivo

Virtual Reality Exposure Therapy

EXPERIMENTAL

This treatment consists of 10 sessions (twice a week) of exposure therapy by using virtual environments. The difference between the exposure in vivo and virtual reality exposure therapy is the exposure component, which will be delivered in vivo in one condition and through the Head Mounted Display (HMD) in the other condition.

Behavioral: Virtual Reality Exposure Therapy

Wait-list

NO INTERVENTION

Participants on the wait-list will be offered either exposure in vivo or in virtual reality after a waiting period of five weeks.

Interventions

Exposure in vivo BEHAVIORAL

Also known as: Behavior Therapy

Exposure in vivo

Virtual Reality Exposure Therapy BEHAVIORAL

Also known as: Virtual Reality Therapy

Virtual Reality Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• a primary diagnosis of social anxiety disorder as measured with the SCID
• fluency in Dutch.

You may not qualify if:

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

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

University of Amsterdam, Department of Clinical Psychology

Amsterdam, 1018 XA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30795749 DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

Behavior Therapy; Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Desensitization, Psychologic

Study Officials

• Paul GM Emmelkamp, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

• Nexhmedin Morina, PhD

  University of Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: December 11, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

NL (1)