Virtual Reality Exposure Therapy for Public Speaking Anxiety

NCT03885414 | Completed

• 1 other identifier: VRETA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual Reality exposure therapy (VRET) is an efficacious treatment for anxiety disorders but has yet to be implemented in regular care settings. This is arguably due to the limitations of the past generation of VR technology, which was expensive, inaccessible, cumbersome and hard to use. With the advent of consumer VR technology, VRET is now ready for implementation in regular care. This multiple-baseline trial will examine the effectiveness of VRET for public speaking anxiety (PSA) when delivered under real-world conditions at an ordinary, non-specialized mental health clinic, by clinical psychologist with only brief VRET training. Participants will either be self-referred specifically for this treatment, or come through ordinary clinical channels. Self-rated PSA will serve as primary outcome measure and will be measured three times prior to treatment (at screening and twice after a diagnostic screening telephone interview) , four times after onset, at the end of the treatment period, and three months after treatment.

Conditions

Public Speaking; Social Anxiety; Social Anxiety Disorder, Performance Only

Outcome Measures

Primary Outcomes (1)

• Change from baseline: Public Speaking Anxiety Scale

  Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay \& Houlihan, 2016)

  Change from baseline: (1) five days after interview, (2) ten days after interview, (3) 7 days post-OST, (4) 14 days post-OST (5) 21 days post-OST (6) 28 days post-OST, (7) 35 days post-OST, (8) 125 days post-PST

Secondary Outcomes (5)

• Change from baseline: Brunnsviken Brief Quality of life scale

  Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST

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

  Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST

• Change from baseline: Brief Fear of Negative Evaluation Scale

  Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST

• Change from baseline: Patient Health Questionnaire 9-item

  Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST

• Change from baseline: Generalized Anxiety Disorder 7-item

  Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST

Study Arms (1)

OST-VRET + in-vivo transition program

EXPERIMENTAL

One-session treatment (OST) VRET on-location with clinical psychologist (3 hours), followed by a therapist-guided, four-week online program encouraging transition to real-world, in-vivo exposure exercises.

Behavioral: In-session Virtual Reality exposure therapy; Behavioral: Internet-administered transition program

Interventions

In-session Virtual Reality exposure therapy BEHAVIORAL

A series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback.

Also known as: Virtual reality therapy, Exposure therapy, Cognitive behavioral therapy

OST-VRET + in-vivo transition program

Internet-administered transition program BEHAVIORAL

Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.

Also known as: Internet intervention

OST-VRET + in-vivo transition program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have substantial public speaking anxiety (PSAS \>= 60)
• Can travel to PBM clinic on one occasion and pay stipulated patient fee
• Can speak and understand sufficient Swedish
• Have stable access to the internet

You may not qualify if:

• Deficits in sight or balance impacting the VR-experience
• A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar
• Active psychopharmacological treatment, unless stable for last 3 months
• Other ongoing psychological treatment

Sponsors & Collaborators

• Stockholm University: lead
• PBM: collaborator
• Mimerse: collaborator

Study Sites (1)

Department of Psychology

Stockholm, 10691, Sweden

Location

Related Publications (1)

• Lindner P, Miloff A, Fagernas S, Andersen J, Sigeman M, Andersson G, Furmark T, Carlbring P. Therapist-led and self-led one-session virtual reality exposure therapy for public speaking anxiety with consumer hardware and software: A randomized controlled trial. J Anxiety Disord. 2019 Jan;61:45-54. doi: 10.1016/j.janxdis.2018.07.003. Epub 2018 Jul 24.

  PMID: 30054173 BACKGROUND

Related Links

• Study website (Swedish)

MeSH Terms

Conditions

Speech; Phobia, Social

Interventions

Virtual Reality Exposure Therapy; Implosive Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Per Carlbring, PhD

  Stockholm University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multiple baseline

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 21, 2019
• Study Start: January 14, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

SE (1)