VR-based Exposure Training for Adolescents With Fear of Public Speaking

NCT ID: NCT04396392

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-03-03

Brief Summary

Public speaking anxiety (PSA) is a common anxiety with onset in adolescence and early adulthood. With the advent of consumer Virtual Reality (VR) technology, VR-delivered exposure therapy has previously been shown to be efficacious with adults. Virtual reality has existed for several decades, but it is only in the recent years it has become readily available. The new generation of off-the-shelf, consumer VR hardware, can revolutionize the design, availability and dissemination of VR therapist tools for exposure therapies. Importantly, there has been relatively little research on VR delivered exposure of anxiety in social situations compared to other anxiety disorders, presumably due to the complexity of the virtual stimuli required. There has been no study on VR delivered exposure specifically for adolescents until recently. A feasibility and pilot trial laying the foundation of the current study showed great potential in using VR for adolescents with PSA. The current study aims to investigate the efficacy of a self-guided VR intervention compared to a self-guided internet-delivered text-based intervention using a two-phased randomized design. Adolescents aged 13-16 will be invited to participate in the study

Detailed Description

The study is a two-phased intervention study .

Participants with PSA will be randomized into three self-guided intervention groups and one delayed waiting list group as follows:

Group 1: receiving VR intervention (3 weeks)

Group 2: receiving VR intervention (3 weeks) + text-based exposure program (T-B-Exp) (3 weeks)

Group 3: receiving text-based psychoeducation and exposure program (T-B PE + T-B Exp) (6 weeks)

Group 4: Waitlist (3 weeks) + receiving text-based psychoeducation (T-B PE) (3 weeks)

Interventions:

1. The VR intervention is a self-guided and home-based VR intervention that lasts for three weeks and focuses on exposure training. The VR group will receive the VR headset personally, in addition to instructional text about how the VR intervention works, how to use the VR application and how often to train. They will be instructed at least 5 tasks weekly during the intervention program.

2. The text-based Psychoeducation intervention is a three weeks program with three modules. One module will be assigned weekly, together with the weekly assessments, which will be same for all participants. The participants will receive a notification on text message when a module has been assigned to them. Module 1 will include information about the intervention program, psychoeducation about public speaking anxiety, cognitive therapy and case formulation. Module 2 will focus on catastrophic beliefs; how to recognize, how they develop, how they contribute to maintaining the anxiety and how they can be tested. Module 3 focuses on safety strategies; what they are, how they contribute in maintaining anxiety, and how to identify them.

3. The Text-based exposure intervention is a three weeks program with 3 modules. One module will be assigned weekly, together with weekly assessments. The modules will focus on how to practice exposure in real life (in vivo) and relapse prevention.

4. The waitlist group will be in waitlist mode for three weeks while the intervention groups are in phase 1. They will still receive weekly assessments during phase 1.

Conditions

Mental Health Issue; Adolescent Development; Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-based training

receiving only VR intervention

Group Type: EXPERIMENTAL

VR-based training

Intervention Type: BEHAVIORAL

All interventions will be home-based and self-guided. The participants will work on the interventions after school hours at home.

All participants will be randomized into four groups (see Figure 1). All participants will receive an introduction module, with information tailored to their study group. Parents will receive an introduction module with information about the study group their adolescents belong to.

text-based training

receiving only text-based intervention

Group Type: ACTIVE_COMPARATOR

VR-based training

Intervention Type: BEHAVIORAL

All interventions will be home-based and self-guided. The participants will work on the interventions after school hours at home.

All participants will be randomized into four groups (see Figure 1). All participants will receive an introduction module, with information tailored to their study group. Parents will receive an introduction module with information about the study group their adolescents belong to.

VR- and text-based training

receiving both VR intervention and text-based intervention

Group Type: EXPERIMENTAL

VR-based training

Intervention Type: BEHAVIORAL

All interventions will be home-based and self-guided. The participants will work on the interventions after school hours at home.

All participants will be randomized into four groups (see Figure 1). All participants will receive an introduction module, with information tailored to their study group. Parents will receive an introduction module with information about the study group their adolescents belong to.

waiting list

waiting list in phase 1 and text-based training after 3 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VR-based training

All interventions will be home-based and self-guided. The participants will work on the interventions after school hours at home.

All participants will be randomized into four groups (see Figure 1). All participants will receive an introduction module, with information tailored to their study group. Parents will receive an introduction module with information about the study group their adolescents belong to.

Intervention Type: BEHAVIORAL

Other Intervention Names

text-based training

Eligibility Criteria

Inclusion Criteria

Aged 13-16, Symptoms of PSA, as defined by Public Speaking Anxiety Scale (PSAS) which leads to distress and / or negative consequences at school. Based on data from the feasibility study (Kahlon et.al 2019) the cut-off will be PSAS < 55.

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Exclusion Criteria

Current ongoing treatment for mental health problems (psychoactive medication/psychotherapy) impaired eyesight and lack of stereoscopic vision which cause difficulties in the VR experience and balance problems

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• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockholm University

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bergen Municipality Division School

Bergen, Vestland, Norway

Countries

Norway

Other Identifiers

60628

Identifier Type: -

Identifier Source: org_study_id