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

NCT04396392 | Unknown

• 1 other identifier: 60628
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Mental Health Issue; Adolescent Development; Technology

Outcome Measures

Primary Outcomes (1)

• Change in Public Speaking Anxiety Scale

  A new, modern, reliable and valid self-rating scale (Bartholomay \& Houlihan, 2016). The PSAS features 17 items (5 of which are reverse-coded) covering cognitive, behavioral and physiological aspects of PSA. Since the PSAS features a full Likert item response format, it should be more sensitive to change than older rating scales such as the Personal Report of Confidence as a Speaker (Phillips, Jones, Rieger, \& Snell, 1997). Normative score data is however as of yet missing. This scale is translated into Norwegian according to scientific standards (back-translation.). Although intended for adults, the wording did not present any problem for adolescents in our feasibility study. lower score means lower symptom-leves

  18 months

Secondary Outcomes (3)

• Change in Social Interaction Anxiety Scale

  18 months

• Change in Catastrophic belief expectancy

  18 months

• Change in Social Phobia Scale

  18 months

Study Arms (4)

VR-based training

EXPERIMENTAL

receiving only VR intervention

Behavioral: VR-based training

text-based training

ACTIVE COMPARATOR

receiving only text-based intervention

Behavioral: VR-based training

VR- and text-based training

EXPERIMENTAL

receiving both VR intervention and text-based intervention

Behavioral: VR-based training

waiting list

NO INTERVENTION

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

Interventions

VR-based training 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.

Also known as: text-based training

VR- and text-based training; VR-based training; text-based training

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Stockholm University: collaborator

Study Sites (1)

Bergen Municipality Division School

Bergen, Vestland, 5003, Norway

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: May 20, 2020
• Study Start: March 1, 2020
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

NO (1)