Clinical trial NCT05573620: ACT and Virtual Reality for Public Speaking Fear
Official title: Training University Students Through Acceptance and Virtual Reality for Coping Public Speaking Fear: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Public Speaking Fear
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization assigned participants to 3 arms:

* in vivo exposure
* virtual reality
* waiting list
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Public Speaking Self-confidence questionnaire PRCS (Paul, 1966)
timeFrame: Change from Baseline psychological inflexibilty at 4 months
Secondary outcomes:
measure: Change in Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Change from Baseline psychological inflexibilty at 4 months
measure: Change in Cognitive Fusion Questionnaire (CFQ)
timeFrame: Change from Baseline psychological inflexibilty at 4 months
measure: Change in Liebowitz Social Anxiety Scale LSAS
timeFrame: Change from Baseline psychological inflexibilty at 4 months
measure: Change in Self-Statements during Public Speaking SSPS
timeFrame: Change from Baseline psychological inflexibilty at 4 months
measure: Change in Public Speaking Self-efficacy and Fear Questionnaire CAHP
timeFrame: Change from Baseline psychological inflexibilty at 4 months
measure: Change in Anxiety intensity subjective scale
timeFrame: Change from Baseline psychological inflexibilty at 4 months
measure: Change in Anxiety interference subjective scale
timeFrame: Through study completion, an average of 4 months
measure: Change in Change in Satisfaction with performance subjective scale
timeFrame: Through study completion, an average of 4 months
measure: Change in Behavioral Checklist for Performance Anxiety (Paul, 1966, adapted by Bados, 1986)
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Universidad Europea de Madrid
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Francisco Montesinos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: