Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2019-03-14
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* in vivo exposure
* virtual reality
* waiting list
TREATMENT
SINGLE
Study Groups
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ACT+In vivo exposure
5 individual weekly sessions which included ACT methods + in vivo exposure
ACT
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.
In vivo exposure:
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+Virtual reality
5 individual weekly sessions which included ACT methods + virtual reality
ACT
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.
Virtual Reality
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...)
Waiting list
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).
No interventions assigned to this group
Interventions
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ACT
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.
In vivo exposure:
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...)
Virtual Reality
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...)
Eligibility Criteria
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Inclusion Criteria
* Significant social anxiety (LSAS Liebowitz Social Anxiety Scale)
* Subjective fear intensity and interference \> 5/10
Exclusion Criteria
* Psychotropic drug consume
* Following psychological/psychiatric treatment
* Serious mental disorder
18 Years
65 Years
ALL
No
Sponsors
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Universidad Europea de Madrid
OTHER
Responsible Party
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Principal Investigators
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Francisco Montesinos, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Universidad Europea de Madrid
Locations
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Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CIPI/19/052
Identifier Type: -
Identifier Source: org_study_id
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