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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001154
Other study ID # VRetorik
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date June 2018

Study information

Verified date March 2019
Source Stockholm University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but because of the high financial costs and technical complexity of the past generation of VR hardware, there has been no large-scale implementation of this promising treatment. The present study will investigate whether off-the-shelf, commercial VR hardware and software can be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The study will recruit n=25+25 participants from the general public suffering from substantial speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered VRET treatment program.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 2018
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Substantial public speaking anxiety

- Have access to VR-compatible smartphone (including Internet)

- Can travel to Stockholm University for treatment on one occasion

- Can speak and understand sufficient Swedish

Exclusion Criteria:

- 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

Study Design


Intervention

Behavioral:
Face-to-face Virtual Reality Exposure Therapy
In session, systematic, hierarchical exposure to feared stimuli with therapist.
Internet-administered Virtual Reality Exposure Therapy
Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program
Other:
Waiting-list
Weekly assessments of public speaking

Locations

Country Name City State
Sweden Department of Psychology Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Public Speaking Anxiety Scale Self-rating of public speaking anxiety Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21
Secondary Liebowitz Social Anxiety Scale Self-Report Self-rating of general social anxiety Change from baseline: Week 0, 5 and 21
Secondary Brief Fear of Negative Evaluation Scale Self-rating of fear of negative evaluation Change from baseline: Week 0, 5 and 21
Secondary Patient Health Questionnaire 9-item Self-rating of depressive symptoms Change from baseline: Week 0, 5 and 21
Secondary Generalized Anxiety Disorder 7-item Self-rating of general anxiety symptoms Change from baseline: Week 0, 5 and 21
Secondary Brunnsviken Brief Quality of life scale Self-rating of quality of life Change from baseline: Week 0, 5 and 21
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