Public SpeakingNCT06086756
Virtual Reality Intervention for Speech Anxiety
A study testing Exposure intervention plus positive mood induction and Exposure intervention plus negative mood induction in people with Public Speaking and Speech Anxiety, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate whether mood state moderates outcome to a brief VR exposure intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Public Speaking, Speech Anxiety
- What is being tested?
- Exposure intervention plus positive mood induction and Exposure intervention plus negative mood induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 5 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-report of 18 years of age or older
- Current student at Boston University
- Ability to read English to provide informed consent
- Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).
- For Phase 2: speech anxiety scale score of ≥ 14 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)
Who cannot join
- Previous participation (i.e., no participant may take the survey more than once).
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders
Boston, Massachusetts, 02215
About this study
Official title: The Influence of Mood on Response to Virtual Reality-Based Exposure for Public Speaking Anxiety
Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate whether mood state moderates outcome to a brief VR exposure intervention.
Read the detailed description
The goal of this clinical trial is to compare outcomes of VR exposure therapy for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to determine whether mood state prior to engaging in a brief VR exposure therapy session for public speaking anxiety impacts treatment outcomes.
The study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing VR based exposure therapy. Public speaking and social anxiety outcomes are measured immediately post-intervention and one week later.
Researchers will compare participants given a positive mood induction to participants given a negative mood induction to see if public speaking anxiety outcomes differ.
- Conditions
- Public Speaking, Speech Anxiety
- Being tested
- Exposure intervention plus positive mood induction, Exposure intervention plus negative mood induction
- Medical subject headings
- Speech, Glossophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure intervention plus positive mood inductionBehavioural
Positive mood induction followed by a brief VR exposure session for public speaking anxiety.
Exposure intervention plus negative mood inductionBehavioural
Negative mood induction followed by a brief VR exposure session for public speaking anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Positive Mood Induction via positive film clips | Experimental | The standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, \& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit positive affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \& Otto, 2018). Together, the two film clips will last for approximately 5 minutes. Receives: Behavioral: Exposure intervention plus positive mood induction |
| Negative Mood Induction via negative film clips | Experimental | The standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, \& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit negative affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \& Otto, 2018). Together, the two film clips will last for approximately 5 minutes. Receives: Behavioral: Exposure intervention plus negative mood induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Public Speaking Anxiety
Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)
Measured: Comparison of pre-exposure scores to scores from post-treatment, approximately 2 week post-screen
Secondary outcomes (3)
Valence
Self-report measure of how participant feels about having to give a speech
Measured: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
Social Phobia
Assessed using the social phobia inventory (SPIN)
Measured: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
Public Speaking Anxiety
Assessed using the PRCA-PS
Measured: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Nov 2023
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Public SpeakingStudies 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
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias Culver, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086756
- Sponsor's protocol ID
- 7164E
- Status last verified
- Dec 2023
- First submitted
- 2 Oct 2023
- Last updated
- 13 Dec 2023
- Results posted
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mood on Response to Virtual Reality-Based Exposure for Public Speaking Anxiety
- ClinicalTrials.gov ID
- NCT06086756
- Acronym / sponsor ID
- 7164E
- Conditions
- Public Speaking, Speech Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 17 Oct 2023 (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.
Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate whether mood state moderates outcome to a brief VR exposure intervention.
Detailed description
The goal of this clinical trial is to compare outcomes of VR exposure therapy for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to determine whether mood state prior to engaging in a brief VR exposure therapy session for public speaking anxiety impacts treatment outcomes.
The study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing VR based exposure therapy. Public speaking and social anxiety outcomes are measured immediately post-intervention and one week later.
Researchers will compare participants given a positive mood induction to participants given a negative mood induction to see if public speaking anxiety outcomes differ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Mood Induction via positive film clips | Experimental | Behavioral: Exposure intervention plus positive mood inductionThe standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, \& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit positive affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \& Otto, 2018). Together, the two film clips will last for approximately 5 minutes. |
| Negative Mood Induction via negative film clips | Experimental | Behavioral: Exposure intervention plus negative mood inductionThe standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, \& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit negative affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \& Otto, 2018). Together, the two film clips will last for approximately 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-report of 18 years of age or older
- Current student at Boston University
- Ability to read English to provide informed consent
- Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).
- For Phase 2: speech anxiety scale score of ≥ 14 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)
Key exclusion criteria (1 listed)
- Previous participation (i.e., no participant may take the survey more than once).
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 |
|---|---|---|
| Exposure intervention plus positive mood inductionPositive mood induction followed by a brief VR exposure session for public speaking anxiety. | Behavioural | Positive Mood Induction via positive film clips |
| Exposure intervention plus negative mood inductionNegative mood induction followed by a brief VR exposure session for public speaking anxiety. | Behavioural | Negative Mood Induction via negative film clips |
Primary outcome
Public Speaking Anxiety
Time frame: Comparison of pre-exposure scores to scores from post-treatment, approximately 2 week post-screen
Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)
3 secondary outcomes
Valence
Time frame: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
Social Phobia
Time frame: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
Public Speaking Anxiety
Time frame: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
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 13 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Elias Culver principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure intervention plus positive mood induction and Exposure intervention plus negative mood induction in people with Public Speaking and Speech Anxiety, run by Boston University Charles River Campus at 1 site in United States.
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 5 inclusion and 1 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 13 Dec 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 United States. 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?
Public Speaking Anxiety (time frame: Comparison of pre-exposure scores to scores from post-treatment, approximately 2 week post-screen). 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 13 Dec 2023.