Clinical trial NCT03970187: Investigation of the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking
Official title: Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Public Speaking (Subclinical)
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled single-blind study design.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Subjective Units of Distress Scale (SUDS, fear)
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Secondary outcomes:
measure: Global external assessment of performance in an in vivo public speech test
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Total time of eye contact during an in vivo public speech test
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Fear of eye contact (SUDS, eye contact)
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Global self-assessment of performance in an in vivo public speech test
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Global subjectively perceived improvement of fear, eye contact and performance after single VR-exposure/waitlist
timeFrame: Assessed at visit 1 after completing the second PST
measure: Global subjectively perceived improvement of fear, eye contact and performance after VR-training/waitlist
timeFrame: Assessed at visit 2 after completing the PST
measure: Questionnaire for social anxiety (Soziale-Phobie-Inventar; SPIN)
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Questionnaire for fear of negative evaluation (The Furcht vor negativer Evaluation - Kurzskala; FNE-K)
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Eye-tracking measures
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Physiological measures
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Other outcomes:
measure: Feature-specific external and self-assessment of performance in an in vivo public speech test (VAS-ratings)
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Vocal indices of stress
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
measure: Simulation sickness in VR
timeFrame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
state: BS
Study officials:
affiliation: University of Basel, Division of Cognitive Neuroscience
name: Dominique de Quervain, MD
role: STUDY_DIRECTOR
References: