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出境医 / 临床实验 / Investigation of the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking (ASSIST-2019)

Investigation of the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking (ASSIST-2019)

Study Description
Brief Summary:
Investigation of the efficacy of an eye contact training App in virtual reality, based on principles of exposure therapy for the treatment for subjects with fear of public speaking.

Condition or disease Intervention/treatment Phase
Fear of Public Speaking (Subclinical) Other: Exposure-based eye contact training in Virtual Reality (VR) Not Applicable

Detailed Description:

The study will be conducted as a randomized controlled single-blind study in a parallel groups design.

Participants will be divided into groups afraid of public speaking with and without fulfilling the criteria of social anxiety (according to DSM-V), which can represent a clinically relevant and more generalized form of public speaking anxiety. The treatment for the participants solely differs in terms of whether they receive (1) the VR exposure or (2) a fear-unrelated VR task (study phase 1) or no treatment at all (study phase 2), resulting in the following 2 groups:

  • Group 1 (treatment group) consists of individuals with fear of public speaking that will (in study phase 1) receive a three-session VR exposure and undergo (in study phase 2) a 2-week treatment period with the same VR scenarios, each repeated three times.
  • Group 2 (control group) consists of individuals with fear of public speaking that will not receive any active treatment but complete a distractor task in VR in study phase 1 and no treatment in study phase 2.

In study phase 1, the treatment group receives three VR exposure sessions each lasting for 20 minutes, whereas the control group completes three virtual distractor tasks (e.g. virtual tours) of identical duration. In study phase 2, the treatment group completes a home training spanning two weeks (9 x 20-minutes sessions), whereas the control group does not receive any treatment (untreated comparison group).

In study phase 1, before and after the virtual exposure session, participants undergo an in vivo PST to assess the acute effects of the VR exposure-based eye contact training App.

In study phase 2, the participants undergo a third in vivo PST to assess the training effects of the VR exposure-based eye contact training after two weeks of home training.

This design allows a direct isolation and comparison of acute effects (study phase 1) and of training effects (study phase 2) and therefore enables an overall estimation of the effectiveness of the VR exposure-based eye contact training.

Approximately 96 participants between 18 and 40 years with fear of public speaking will take part in the study. Approximately 1 to 5 weeks after having finished the first study phase, all participants that have not dropped out will take part in the second study phase.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled single-blind study design.
Masking: Single (Investigator)
Masking Description: Investigators evaluating the (external) performance in the in vivo Public Speech Test (PST) will be blinded (unaware of group assignment of participants, single-blind).
Primary Purpose: Other
Official Title: Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : September 20, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Exposure
Phase 1 (visit 1): 60 minutes exposure-based eye contact training in VR Phase 2 (home training): 9 blocks of 20 minutes exposure-based eye contact training in VR, distributed over a total duration of maximally 2 weeks
Other: Exposure-based eye contact training in Virtual Reality (VR)

The intervention is an App for virtual reality. The VR App provides three different virtual scenarios. Participants will be asked to stand in front of a virtual audience and to maintain eye contact with audience members. The advance to higher difficulty levels is according to a pre-defined exposure scheme. Participants will be given all instructions via the App.

There will be three sessions on one day (duration of 20 min each) in study phase 1. The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking. In the study phase 2, there will be nine sessions spanning over two weeks (duration of 20 min each, with maximally one session per day). The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking.


No Intervention: Control

Phase 1 (visit 1): waitlist. In order to prevent systematic preparation for the subsequent PST, a 60 minutes virtual reality games with fear-unrelated content will serve as the control intervention.

Phase 2 (home training): waitlist

Outcome Measures
Primary Outcome Measures :
  1. Subjective Units of Distress Scale (SUDS, fear) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.


Secondary Outcome Measures :
  1. Global external assessment of performance in an in vivo public speech test [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The global external assessment of performance is done by averaging VAS-ratings (range from 0 = very bad performance to 100 = very good performance) of the PST from three independent members of a committee (experimenters) and a forth experimenter that will rate the performances using a video and audio recording from the speeches.

  2. Total time of eye contact during an in vivo public speech test [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Total time of eye contact is measured by a mobile eye tracking device from Pupil Labs and operationalized by the number of frames the gaze is in predefined regions of interest comprising the eyes of the committee members.

  3. Fear of eye contact (SUDS, eye contact) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.

  4. Global self-assessment of performance in an in vivo public speech test [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The global self-assessment of performance is done by a VAS-ratings (range from 0 = very bad performance to 100 = very good performance) of the PST

  5. Global subjectively perceived improvement of fear, eye contact and performance after single VR-exposure/waitlist [ Time Frame: Assessed at visit 1 after completing the second PST ]
    Global subjectively perceived improvement of fear, eye contact and performance by the VR eye contact training App will be done by VAS-ratings

  6. Global subjectively perceived improvement of fear, eye contact and performance after VR-training/waitlist [ Time Frame: Assessed at visit 2 after completing the PST ]
    Global subjectively perceived improvement of fear, eye contact and performance by the VR eye contact training App will be done by VAS-ratings

  7. Questionnaire for social anxiety (Soziale-Phobie-Inventar; SPIN) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The SPIN is a 17-item questionnaire developed by the Psychiatry and Behavioral Sciences Department at Duke University. It is effective in screening for, and measuring the severity of fear related to the negative evaluation by others. The 17 items cover different aspects of the anxiety such as fear, avoidance, and physiological symptoms on 5-point Likert scales. The statements of the SPIN items indicate the particular signs of public speaking anxiety (e.g. "I am bothered by blushing in front of people"). The SPIN demonstrates solid psychometric properties and is valid as a measurement for the severity and clinical relevance of fear related symptoms (Connor et al., 2000).

  8. Questionnaire for fear of negative evaluation (The Furcht vor negativer Evaluation - Kurzskala; FNE-K) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The FNE-K is a frequently used, valid, and reliable self-report questionnaire consisting of 12 items measuring fear and distress related to negative evaluation by others (e.g. "I am afraid that people will find fault with me") on 4-point Likert scales. The FNE-K has demonstrated good reliability and validity (Reichenberger et al., 2016).

  9. Eye-tracking measures [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Gaze behaviour (fixation frequency and location, scan path characteristics) and pupil size

  10. Physiological measures [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Salivary cortisol levels


Other Outcome Measures:
  1. Feature-specific external and self-assessment of performance in an in vivo public speech test (VAS-ratings) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Feature-specific assessment of the participants performance in the in vivo PST is measured by VAS-ratings (from 0 = very bad to 100 = very good) from three independent members of a committee. A forth experimenter will rate the performances using a video and audio recording from the speeches. 8 specific VAS-ratings covering nonverbal aspects of performances (e.g. facial expression, gestures etc.) are divided into two subscales with 4 VAS-ratings each (1 = speech, 2 = appearance).

  2. Vocal indices of stress [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Vocal indices of stress comprise f.e. level and variability of the fundamental frequency or the active speech duration. They will be measured by analysing the audio recordings during the PST.

  3. Simulation sickness in VR [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Safety outcome, assessed by the Simulator Sickness Questionnaire (SSQ)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fear of public speaking, assessed by two separate aspects:
  • High fear in social situations including the potential of being evaluated by others
  • Social situations can only be withstood under high fear or are avoided
  • Aged between 18-40
  • Fluent in German

Exclusion Criteria:

  • BDI-II sumscore >= 20
  • Suicidal ideation (BDI-II item 9 > 0)
  • Serious medical or psychological condition, other than social anxiety (including Depression, Epilepsy and Migraine)
  • Concurrent psychotherapy
  • Previous exposure-based therapy for social anxiety (including public speaking anxiety) or other anxiety disorders
  • Parallel participation in another psychological or medical study
  • Chronic medication intake (except oral contraceptives)
  • Chronic drug intake (i.e. LSD, mushrooms, Ecstasy, MDMA, amphetamines etc.)
  • Medication intake before visits (less than 24 h)
  • Alcohol intake before visits (less than 12 h)
  • Cannabis or other psychoactive substances (including benzodiazepines) intake before visits (less than 5 days)
  • Restricted 3D sight
  • For women: Current pregnancy
Contacts and Locations

Locations
Layout table for location information
Switzerland
University of Basel, Division of Cognitive Neuroscience
Basel, BS, Switzerland, 4055
Sponsors and Collaborators
Prof. Dominique de Quervain, MD
Investigators
Layout table for investigator information
Study Director: Dominique de Quervain, MD University of Basel, Division of Cognitive Neuroscience
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE June 1, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
Subjective Units of Distress Scale (SUDS, fear) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Global external assessment of performance in an in vivo public speech test [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The global external assessment of performance is done by averaging VAS-ratings (range from 0 = very bad performance to 100 = very good performance) of the PST from three independent members of a committee (experimenters) and a forth experimenter that will rate the performances using a video and audio recording from the speeches.
  • Total time of eye contact during an in vivo public speech test [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Total time of eye contact is measured by a mobile eye tracking device from Pupil Labs and operationalized by the number of frames the gaze is in predefined regions of interest comprising the eyes of the committee members.
  • Fear of eye contact (SUDS, eye contact) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.
  • Global self-assessment of performance in an in vivo public speech test [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The global self-assessment of performance is done by a VAS-ratings (range from 0 = very bad performance to 100 = very good performance) of the PST
  • Global subjectively perceived improvement of fear, eye contact and performance after single VR-exposure/waitlist [ Time Frame: Assessed at visit 1 after completing the second PST ]
    Global subjectively perceived improvement of fear, eye contact and performance by the VR eye contact training App will be done by VAS-ratings
  • Global subjectively perceived improvement of fear, eye contact and performance after VR-training/waitlist [ Time Frame: Assessed at visit 2 after completing the PST ]
    Global subjectively perceived improvement of fear, eye contact and performance by the VR eye contact training App will be done by VAS-ratings
  • Questionnaire for social anxiety (Soziale-Phobie-Inventar; SPIN) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The SPIN is a 17-item questionnaire developed by the Psychiatry and Behavioral Sciences Department at Duke University. It is effective in screening for, and measuring the severity of fear related to the negative evaluation by others. The 17 items cover different aspects of the anxiety such as fear, avoidance, and physiological symptoms on 5-point Likert scales. The statements of the SPIN items indicate the particular signs of public speaking anxiety (e.g. "I am bothered by blushing in front of people"). The SPIN demonstrates solid psychometric properties and is valid as a measurement for the severity and clinical relevance of fear related symptoms (Connor et al., 2000).
  • Questionnaire for fear of negative evaluation (The Furcht vor negativer Evaluation - Kurzskala; FNE-K) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    The FNE-K is a frequently used, valid, and reliable self-report questionnaire consisting of 12 items measuring fear and distress related to negative evaluation by others (e.g. "I am afraid that people will find fault with me") on 4-point Likert scales. The FNE-K has demonstrated good reliability and validity (Reichenberger et al., 2016).
  • Eye-tracking measures [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Gaze behaviour (fixation frequency and location, scan path characteristics) and pupil size
  • Physiological measures [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Salivary cortisol levels
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 29, 2019)
  • Feature-specific external and self-assessment of performance in an in vivo public speech test (VAS-ratings) [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Feature-specific assessment of the participants performance in the in vivo PST is measured by VAS-ratings (from 0 = very bad to 100 = very good) from three independent members of a committee. A forth experimenter will rate the performances using a video and audio recording from the speeches. 8 specific VAS-ratings covering nonverbal aspects of performances (e.g. facial expression, gestures etc.) are divided into two subscales with 4 VAS-ratings each (1 = speech, 2 = appearance).
  • Vocal indices of stress [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Vocal indices of stress comprise f.e. level and variability of the fundamental frequency or the active speech duration. They will be measured by analysing the audio recordings during the PST.
  • Simulation sickness in VR [ Time Frame: Assessing change between baseline and predefined follow-up time points during 11 weeks ]
    Safety outcome, assessed by the Simulator Sickness Questionnaire (SSQ)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Investigation of the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking
Official Title  ICMJE Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking
Brief Summary Investigation of the efficacy of an eye contact training App in virtual reality, based on principles of exposure therapy for the treatment for subjects with fear of public speaking.
Detailed Description

The study will be conducted as a randomized controlled single-blind study in a parallel groups design.

Participants will be divided into groups afraid of public speaking with and without fulfilling the criteria of social anxiety (according to DSM-V), which can represent a clinically relevant and more generalized form of public speaking anxiety. The treatment for the participants solely differs in terms of whether they receive (1) the VR exposure or (2) a fear-unrelated VR task (study phase 1) or no treatment at all (study phase 2), resulting in the following 2 groups:

  • Group 1 (treatment group) consists of individuals with fear of public speaking that will (in study phase 1) receive a three-session VR exposure and undergo (in study phase 2) a 2-week treatment period with the same VR scenarios, each repeated three times.
  • Group 2 (control group) consists of individuals with fear of public speaking that will not receive any active treatment but complete a distractor task in VR in study phase 1 and no treatment in study phase 2.

In study phase 1, the treatment group receives three VR exposure sessions each lasting for 20 minutes, whereas the control group completes three virtual distractor tasks (e.g. virtual tours) of identical duration. In study phase 2, the treatment group completes a home training spanning two weeks (9 x 20-minutes sessions), whereas the control group does not receive any treatment (untreated comparison group).

In study phase 1, before and after the virtual exposure session, participants undergo an in vivo PST to assess the acute effects of the VR exposure-based eye contact training App.

In study phase 2, the participants undergo a third in vivo PST to assess the training effects of the VR exposure-based eye contact training after two weeks of home training.

This design allows a direct isolation and comparison of acute effects (study phase 1) and of training effects (study phase 2) and therefore enables an overall estimation of the effectiveness of the VR exposure-based eye contact training.

Approximately 96 participants between 18 and 40 years with fear of public speaking will take part in the study. Approximately 1 to 5 weeks after having finished the first study phase, all participants that have not dropped out will take part in the second study phase.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled single-blind study design.
Masking: Single (Investigator)
Masking Description:
Investigators evaluating the (external) performance in the in vivo Public Speech Test (PST) will be blinded (unaware of group assignment of participants, single-blind).
Primary Purpose: Other
Condition  ICMJE Fear of Public Speaking (Subclinical)
Intervention  ICMJE Other: Exposure-based eye contact training in Virtual Reality (VR)

The intervention is an App for virtual reality. The VR App provides three different virtual scenarios. Participants will be asked to stand in front of a virtual audience and to maintain eye contact with audience members. The advance to higher difficulty levels is according to a pre-defined exposure scheme. Participants will be given all instructions via the App.

There will be three sessions on one day (duration of 20 min each) in study phase 1. The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking. In the study phase 2, there will be nine sessions spanning over two weeks (duration of 20 min each, with maximally one session per day). The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking.

Study Arms  ICMJE
  • Experimental: Exposure
    Phase 1 (visit 1): 60 minutes exposure-based eye contact training in VR Phase 2 (home training): 9 blocks of 20 minutes exposure-based eye contact training in VR, distributed over a total duration of maximally 2 weeks
    Intervention: Other: Exposure-based eye contact training in Virtual Reality (VR)
  • No Intervention: Control

    Phase 1 (visit 1): waitlist. In order to prevent systematic preparation for the subsequent PST, a 60 minutes virtual reality games with fear-unrelated content will serve as the control intervention.

    Phase 2 (home training): waitlist

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 20, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fear of public speaking, assessed by two separate aspects:
  • High fear in social situations including the potential of being evaluated by others
  • Social situations can only be withstood under high fear or are avoided
  • Aged between 18-40
  • Fluent in German

Exclusion Criteria:

  • BDI-II sumscore >= 20
  • Suicidal ideation (BDI-II item 9 > 0)
  • Serious medical or psychological condition, other than social anxiety (including Depression, Epilepsy and Migraine)
  • Concurrent psychotherapy
  • Previous exposure-based therapy for social anxiety (including public speaking anxiety) or other anxiety disorders
  • Parallel participation in another psychological or medical study
  • Chronic medication intake (except oral contraceptives)
  • Chronic drug intake (i.e. LSD, mushrooms, Ecstasy, MDMA, amphetamines etc.)
  • Medication intake before visits (less than 24 h)
  • Alcohol intake before visits (less than 12 h)
  • Cannabis or other psychoactive substances (including benzodiazepines) intake before visits (less than 5 days)
  • Restricted 3D sight
  • For women: Current pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970187
Other Study ID Numbers  ICMJE 2019-00514
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dominique de Quervain, MD, University of Basel
Study Sponsor  ICMJE Prof. Dominique de Quervain, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dominique de Quervain, MD University of Basel, Division of Cognitive Neuroscience
PRS Account University of Basel
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP