Clinical trial NCT04396392: VR-based Exposure Training for Adolescents With Fear of Public Speaking
Official title: VR-based Training for Adolescents With Fear of Public Speaking, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Adolescent Development
Technology
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm University
First posted: 2020-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: Inclusion:

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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Primary outcomes:
measure: Change in Public Speaking Anxiety Scale
timeFrame: 18 months
Secondary outcomes:
measure: Change in Social Interaction Anxiety Scale
timeFrame: 18 months
measure: Change in Catastrophic belief expectancy
timeFrame: 18 months
measure: Change in Social Phobia Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen Municipality Division School
state: Vestland
Study officials:
References: