ACT and Virtual Reality for Public Speaking Fear

NCT ID: NCT05573620

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-14

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Public Speaking Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization assigned participants to 3 arms:

* in vivo exposure
* virtual reality
* waiting list
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants did not know that two different treatments were delivered.

Study Groups

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ACT+In vivo exposure

5 individual weekly sessions which included ACT methods + in vivo exposure

Group Type EXPERIMENTAL

ACT

Intervention Type 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:

Intervention Type 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...)

ACT+Virtual reality

5 individual weekly sessions which included ACT methods + virtual reality

Group Type EXPERIMENTAL

ACT

Intervention Type 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.

Virtual Reality

Intervention Type 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...)

Waiting list

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ACT

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.

Intervention Type BEHAVIORAL

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...)

Intervention Type BEHAVIORAL

Virtual Reality

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...)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco Montesinos, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

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Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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CIPI/19/052

Identifier Type: -

Identifier Source: org_study_id

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