Training University Students Through Acceptance and Virtual Reality for Coping Public Speaking Fear: a Clinical Trial
Phase: NA
Conditions: Public Speaking Fear
Sponsor: Universidad Europea de Madrid

 
 
 
 
 
 
 
Training University Students through Acceptance and Virtual Reality 
for Coping Public Speaking Fear: a Clinical Trial 
ID: CIPI/19/052 
Document date: 14th March 2019 
IP: Francisco Montesinos, Ph.D. 
Study Protocol and Statistical Analysis Plan  
 
 
 

Study Protocol:  
• Objective: To study the efficacy of in vivo exposure and virtual 
reality combined with Acceptance and Commitment Therapy to treat 
public speaking fear. 
• Design: Randomized clinical trial 
• Methods.  
 
After being informed about the study, all patients giving written 
informed consent will be assessed to determine eligibility for study 
entry. Patients who meet eligibility requirements will be assessed 
through an structured interview, behavioural observation, standardize 
questionnaires and subjective scales and assigned to a waiting list, in 
vivo exposure or Virtual Reality.  
 
Assessment will provide specific information to sort topics (health, 
culture and arts, equality, education, environmental protection, 
human relationships, ethical dilemmas) and distractors (people 
talking, coughing, laughing, yawning, mobile phone ringing, mobile 
phone vibrating, audience asking easy/hard questions, one person 
stands up) for oral presentations from most to least 
difficult/troublesome. This will allow therapist to build a 
personalized exposure hierarchy for every participant. 
Participants assigned to in vivo or virtual reality arms will receive 
psychological intervention consisting in a 5-session individual face-
to-face ACT-based treatment. Virtual reality will be delivered 
through Psious platform distributed in Spain by TEA and through a 
Virtual Reality equipment including a Samsung S7 mobile and 
36 participants
18 (in vivo)
9 (Inmediate 
intervention)
9 (Waiting list + 
intervention 
5 weeks later)
18 (virtual 
reality)
9 (Inmediate 
intervention)
9 (Waiting list + 
intervention 
5 weeks later)

Samsung Gear VR glasses. The audience in In vivo exposure will be 
made up of university students. 
Every session in In vivo and virtual reality conditions will include a 
12-minute oral presentation. Participants will be asked to improvise a 
talk about a new topic (e.g. violence against women, education 
system in Spain, new technologies, political corruption, cinema and 
TV series, climate change, healthy nutrition…). Participants will 
have 3 minutes to prepare their speech. Difficulty will progressively 
increase based on each participant's pre assessment (considering 
topics and distractors) 
The participants will be assessed through self-report instruments and 
observational measurements before and after treatment and at 3 
months follow-up.  
Intervention protocol. 
Session 1. Values clarification through ‘the dreamed professional 
exercise’ (variation on ‘imagine your funeral’ exercise). Introducing 
acceptance through ‘Ship’s captain metaphor’. Training cognitive 
defusion through imaginal exposure (physicalizing exercise, and 
watching thoughts as graffiti) (Hayes et al., 2012).  
Sessions 2, 3, 4, 5.  
• Part 1. Training cognitive defusion through imaginal exposure 
(physicalizing exercise, and watching thoughts as graffiti) 
(Hayes et al., 2012).  
• Part 2. In situ exposure to valued actions. Virtual Reality or In 
Vivo exposure (improvisation of a 12 minute oral 
presentation, after 2 minutes to prepare).  
• Part 3. Feedback. Positive reinforcement. Self-monitoring 
(homework) 
Statistical Analysis Plan (SAP):  
The results will be analysed through non-parametric techniques 
(comparisons of pre, post and follow-up group means). An analysis of 
variance will be performed to determine the specific weight of each 
independent variable, as well as the possible interaction between them. The 
statistical approach of Jacobson and Truax (1991) will be used to estimate 
the clinical significance of the effect.