NCT05573620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

September 13, 2022

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline psychological inflexibilty at 4 months

Secondary Outcomes (9)

  • Change in Acceptance and Action Questionnaire (AAQ-II)

    Change from Baseline psychological inflexibilty at 4 months

  • Change in Cognitive Fusion Questionnaire (CFQ)

    Change from Baseline psychological inflexibilty at 4 months

  • Change in Liebowitz Social Anxiety Scale LSAS

    Change from Baseline psychological inflexibilty at 4 months

  • Change in Self-Statements during Public Speaking SSPS

    Change from Baseline psychological inflexibilty at 4 months

  • Change in Public Speaking Self-efficacy and Fear Questionnaire CAHP

    Change from Baseline psychological inflexibilty at 4 months

  • +4 more secondary outcomes

Study Arms (3)

ACT+In vivo exposure

EXPERIMENTAL

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

Behavioral: ACTBehavioral: In vivo exposure:

ACT+Virtual reality

EXPERIMENTAL

5 individual weekly sessions which included ACT methods + virtual reality

Behavioral: ACTBehavioral: 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).

Interventions

ACTBEHAVIORAL

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.

ACT+In vivo exposureACT+Virtual reality

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+In vivo exposure
Virtual RealityBEHAVIORAL

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...)

ACT+Virtual reality

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Student at European University of Madrid, Spain
  • Significant social anxiety (LSAS Liebowitz Social Anxiety Scale)
  • Subjective fear intensity and interference \> 5/10

You may not qualify if:

  • Alcohol or drugs abuse
  • Psychotropic drug consume
  • Following psychological/psychiatric treatment
  • Serious mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Glossophobia

Study Officials

  • Francisco Montesinos, Ph.D.

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants did not know that two different treatments were delivered.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization assigned participants to 3 arms: * in vivo exposure * virtual reality * waiting list
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

October 10, 2022

Study Start

March 14, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations