Public Speaking FearNCT05573620
ACT and Virtual Reality for Public Speaking Fear
A study testing ACT, In vivo exposure: and Virtual Reality in people with Public Speaking Fear, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Public Speaking Fear
- What is being tested?
- ACT, In vivo exposure: and Virtual Reality
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Student at European University of Madrid, Spain
- Significant social anxiety (LSAS Liebowitz Social Anxiety Scale)
- Subjective fear intensity and interference > 5/10
Who cannot join
- Alcohol or drugs abuse
- Psychotropic drug consume
- Following psychological/psychiatric treatment
- Serious mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training University Students Through Acceptance and Virtual Reality for Coping Public Speaking Fear: a Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Public Speaking Fear
- Being tested
- ACT, In vivo exposure:, Virtual Reality
- Medical subject headings
- Glossophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
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:Behavioural
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 RealityBehavioural
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...)
| Study group | Role | What they receive |
|---|---|---|
| ACT+In vivo exposure | Experimental | 5 individual weekly sessions which included ACT methods + in vivo exposure Receives: Behavioral: ACT; Behavioral: In vivo exposure: |
| ACT+Virtual reality | Experimental | 5 individual weekly sessions which included ACT methods + virtual reality Receives: Behavioral: ACT; Behavioral: Virtual Reality |
| Waiting list | No intervention | Participants assigned to Waiting List arm waited for 5 weeks before receiving treatment (i.e., after completing the measures they continued in the study and then were randomly assigned to ACT+in vivo exposure or ACT+virtual reality arms). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Public Speaking Self-confidence questionnaire PRCS (Paul, 1966)
'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.
Measured: Change from Baseline psychological inflexibilty at 4 months
Secondary outcomes (9)
Change in Acceptance and Action Questionnaire (AAQ-II)
'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.
Measured: Change from Baseline psychological inflexibilty at 4 months
Change in Cognitive Fusion Questionnaire (CFQ)
'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.
Measured: Change from Baseline psychological inflexibilty at 4 months
Change in Liebowitz Social Anxiety Scale LSAS
'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.
Measured: Change from Baseline psychological inflexibilty at 4 months
Change in Self-Statements during Public Speaking SSPS
'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.
Measured: Change from Baseline psychological inflexibilty at 4 months
Change in Public Speaking Self-efficacy and Fear Questionnaire CAHP
'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.
Measured: Change from Baseline psychological inflexibilty at 4 months
Change in Anxiety intensity subjective scale
'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.
Measured: Change from Baseline psychological inflexibilty at 4 months
Change in Anxiety interference subjective scale
'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.
Measured: Through study completion, an average of 4 months
Change in Change in Satisfaction with performance subjective scale
'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.
Measured: Through study completion, an average of 4 months
Change in Behavioral Checklist for Performance Anxiety (Paul, 1966, adapted by Bados, 1986)
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.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start14 Mar 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Public Speaking FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization assigned participants to 3 arms: * in vivo exposure * virtual reality * waiting list
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Montesinos, Ph.D., Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573620
- Sponsor's protocol ID
- CIPI/19/052
- Status last verified
- May 2023
- First submitted
- 13 Sep 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training University Students Through Acceptance and Virtual Reality for Coping Public Speaking Fear: a Clinical Trial
- ClinicalTrials.gov ID
- NCT05573620
- Acronym / sponsor ID
- CIPI/19/052
- Conditions
- Public Speaking Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomization assigned participants to 3 arms: * in vivo exposure * virtual reality * waiting list
| Arm | Type | Receives |
|---|---|---|
| ACT+In vivo exposure | Experimental | Behavioral: ACT, Behavioral: In vivo exposure:5 individual weekly sessions which included ACT methods + in vivo exposure |
| ACT+Virtual reality | Experimental | Behavioral: ACT, Behavioral: Virtual Reality5 individual weekly sessions which included ACT methods + virtual reality |
| Waiting list | No intervention | –Participants assigned to Waiting List arm waited for 5 weeks before receiving treatment (i.e., after completing the measures they continued in the study and then were randomly assigned to ACT+in vivo exposure or ACT+virtual reality arms). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Student at European University of Madrid, Spain
- Significant social anxiety (LSAS Liebowitz Social Anxiety Scale)
- Subjective fear intensity and interference > 5/10
Key exclusion criteria (4 listed)
- Alcohol or drugs abuse
- Psychotropic drug consume
- Following psychological/psychiatric treatment
- Serious mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTAcceptance 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. | Behavioural | ACT+In vivo exposure, ACT+Virtual reality |
| In vivo exposure: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...) | Behavioural | ACT+In vivo exposure |
| Virtual RealityVirtual 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...) | Behavioural | ACT+Virtual reality |
Primary outcome
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.
9 secondary outcomes
Change in Acceptance and Action Questionnaire (AAQ-II)
Time frame: Change from Baseline psychological inflexibilty at 4 months
Change in Cognitive Fusion Questionnaire (CFQ)
Time frame: Change from Baseline psychological inflexibilty at 4 months
Change in Liebowitz Social Anxiety Scale LSAS
Time frame: Change from Baseline psychological inflexibilty at 4 months
Change in Self-Statements during Public Speaking SSPS
Time frame: Change from Baseline psychological inflexibilty at 4 months
Change in Public Speaking Self-efficacy and Fear Questionnaire CAHP
Time frame: Change from Baseline psychological inflexibilty at 4 months
Change in Anxiety intensity subjective scale
Time frame: Change from Baseline psychological inflexibilty at 4 months
Change in Anxiety interference subjective scale
Time frame: Through study completion, an average of 4 months
Change in Change in Satisfaction with performance subjective scale
Time frame: Through study completion, an average of 4 months
Change in Behavioral Checklist for Performance Anxiety (Paul, 1966, adapted by Bados, 1986)
Time frame: Through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
Related trials for Public Speaking Fear
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Virtual Reality as a Tool for Training Public Speaking Skills in Higher Education Students
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Recruiting
Enhancing Generalization of Virtual Reality Exposure for Public Speaking Anxiety
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Recruiting
Group Exposure Workshops for Socially Anxious Undergraduates
Social Anxiety Disorder, Public Speaking Fear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Montesinos, Ph.D. principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT, In vivo exposure: and Virtual Reality in people with Public Speaking Fear, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Public Speaking Self-confidence questionnaire PRCS (Paul, 1966) (time frame: Change from Baseline psychological inflexibilty at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.