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Completed

NCT Number: NCT05573620

ACT and Virtual Reality for Public Speaking Fear

Investigation of Acceptance and Commitment Therapy (ACT) for the psychological treatment of public speaking fear. Two ACT-based treatment delivery modalities (in vivo exposure vs. virtual reality) were compared.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

About this study

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

The clinical trial will include a control group (waiting list).

Patients who meet eligibility requirements will be assigned to a waiting list, in vivo exposure and Virtual Reality.

Psychological intervention consisted in a 5-session individual face-to-face delivered ACT-based treatment.

The participants will be assessed through self-report instruments and observational measurements before and after treatment and at 3 months follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Student at European University of Madrid, Spain
  • Significant social anxiety (LSAS Liebowitz Social Anxiety Scale)
  • Subjective fear intensity and interference > 5/10

Exclusion criteria

  • Alcohol or drugs abuse
  • Psychotropic drug consume
  • Following psychological/psychiatric treatment
  • Serious mental disorder

Treatment and study plan

ACT

Behavioral

Acceptance and Commitment Therapy methods were focused on promoting Values clarification, Acceptance, Cognitive defusion, Committed action and Flexible attention to the present moment, and included 'The dreamed professional exercise' -variation on '"imagine your funeral" exercise'-, Ship's captain metaphor, Imaginal exposure, Physicalizing exercise, and Watching thoughts as graffiti.

In vivo exposure:

Behavioral

The audience was made up of university students. Every session included a 12 minute oral presentation. Participants were asked to improvise a talk about a new topic (e.g. violence against women, education system in Spain…). Participants had 3 minutes to prepare their speech. Difficulty increased based on each participant's pre assessment (topics and distractors as ringtones, audience whispering...)

Virtual reality

Behavioral

Virtual reality was delivered through Psious platform distributed in Spain by TEA and through a Virtual Reality equipment that included a Samsung S7 mobile and Samsung Gear VR glasses.

Every session included a 12 minute oral presentation. Participants were asked to improvise a talk about a new topic (e.g. violence against women, education system in Spain…). Participants had 3 minutes to prepare their speech. Difficulty increased based on each participant's pre assessment (topics and distractors as ringtones, audience whispering...)

Primary outcomes

  1. Change in Public Speaking Self-confidence questionnaire PRCS (Paul, 1966)

    Time frame: Change from Baseline psychological inflexibilty at 4 months

    'Public Speaking Self-confidence questionnaire' assesses public speaking fear. It is a 12-item, five-point Likert-type scale. Scores range between 12 and 60. Higher the score in the questionnaire, indicate higher levels of public speaking fear and worse outcome.

Secondary outcomes

  1. Change in Acceptance and Action Questionnaire (AAQ-II)

    Time frame: Change from Baseline psychological inflexibilty at 4 months

    'Acceptance and Action Questionnaire' assesses psychological inflexibility. It is a 7-item, seven-point Likert-type scale. Scores range between 7 and 49. Higher scores indicate higher levels of psychological inflexibility and worse outcome.

  2. Change in Cognitive Fusion Questionnaire (CFQ)

    Time frame: Change from Baseline psychological inflexibilty at 4 months

    'Cognitive Fusion Questionnaire' assesses cognitive fusion (the tendency to believe the literal content of private events). It is a 7-item, seven-point Likert-type scale. Scores range between 7 and 49. Higher scores in the questionnaire indicate higher levels of cognitive fusion and worse outcome.

  3. Change in Liebowitz Social Anxiety Scale LSAS

    Time frame: Change from Baseline psychological inflexibilty at 4 months

    'Liebowitz Social Anxiety Scale' assesses social anxiety. It is a 24-item, four-point Likert-type scale. Scores range between 0 and 72. Scores above 51 indicates significant social anxiety (González, Bascaran & Saiz, 2001). Higher the score in the questionnaire, indicate higher levels of social anxiety and worse outcome.

  4. Change in Self-Statements during Public Speaking SSPS

    Time frame: Change from Baseline psychological inflexibilty at 4 months

    'Self-Statements during public Speaking questionnaire' assesses positive and negative self-statements. It is a 10-item, six-point Likert-type scale. It includes two subscales. Scores in positive self-statements subscale range between 5 and 30. Higher the score in this subscale, indicate higher levels of positive self-statements and better outcome. Scores in negative self-statements subscale range between 5 and 30. Higher the score in this subscale, indicate higher levels of negative self-statements and worse outcome.

  5. Change in Public Speaking Self-efficacy and Fear Questionnaire CAHP

    Time frame: Change from Baseline psychological inflexibilty at 4 months

    'Public speaking self-efficacy and fear questionnaire' assesses public speaking self-efficacy and public speaking fear. It is a 12-item, six-point Likert-type scale. It includes two subscales (self-efficacy and fear). Scores in self-efficacy subscale range between 12 and 72. Higher the score in the sef-efficacy subscale, indicate higher levels of public speaking self-efficacy and better outcome. Scores in public speaking fear subscale range between 12 and 72. Higher the score in the fear subscale, indicate higher levels of public speaking fear and worse outcome.

  6. Change in Anxiety intensity subjective scale

    Time frame: Change from Baseline psychological inflexibilty at 4 months

    'Anxiety intensity subjective scale' asesses global self-assessment of intensity of public speaking anxiety VAS-ratings (range from 0 = very low intensity to 10 = very high intensity). Higher the score in scale, indicate higher levels of public speaking anxiety intensity and worse outcome.

  7. Change in Anxiety interference subjective scale

    Time frame: Through study completion, an average of 4 months

    'Anxiety interference subjective scale' assesses global self-assessment of interference of public speaking anxiety VAS-ratings (range from 0 = very low interference to 10 = very high interference). Higher the score in scale, indicate higher levels of public speaking anxiety interference and worse outcome.

  8. Change in Change in Satisfaction with performance subjective scale

    Time frame: Through study completion, an average of 4 months

    'Satisfaction with performance subjective scale' assesses global self-assessment of satisfaction with performance VAS-ratings (range from 0 = very low satisfaction to 10 = very high satisfaction). Higher the score in scale, indicate higher satisfaction and better outcome.

  9. Change in Behavioral Checklist for Performance Anxiety (Paul, 1966, adapted by Bados, 1986)

    Time frame: Through study completion, an average of 4 months

    Behavioral Checklist for Performance Anxiety assesses anxiety performance. It includes using video recordings, 'CODIMG' behavioral observation and analysis coding software. It is a 14-items checklist. Scores range between 0 and 14. Higher the score in the checklist, indicate higher levels of anxiety performance and worse outcome.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Training University Students Through Acceptance and Virtual Reality for Coping Public Speaking Fear: a Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 10, 2022
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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