Skip to main content
Clinical Trials/NCT04695249
NCT04695249
Unknown
Not Applicable

Targeting Avoidant Behaviours in Anxiety Disorders Using Individualized 360° Videos: a Multiple Single Case Design

University of Liege1 site in 1 country5 target enrollmentJanuary 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Anxiety Disorder
Sponsor
University of Liege
Enrollment
5
Locations
1
Primary Endpoint
Agoraphobia: avoidance
Last Updated
4 years ago

Overview

Brief Summary

This study aims to test the feasibility and efficacy of an individualized exposure intervention using 360-degree videos for social anxiety and agoraphobia. A multiple single case design is followed with a pre-post-follow up assessment and multiple baselines. In addition, an experience sampling method is used to explore the role of dysfunctional beliefs and self-efficacy in the efficacy intervention.

Detailed Description

There is growing evidence that supports the use of Virtual Reality (VR) to address anxiety disorders such as social anxiety and agoraphobia. The main advantage of VR is to expose participants to their fears in a controlled and safe environment. However, the access to VR remains costly for health professionals who need to pay licenses for the use of a limited number of environments. Therefore, these standardized environments only address the symptoms of standard anxious patients. As a way to provide an accessible tool that can be tailored according to patients' specific difficulties, the proposed approach builds on 360-degree videos as an alternative to VR. The aim of the present study is to test the feasibility and efficacy of an individualized expo-sure intervention using 360-degree videos. In addition, the role of cognitive processes (i.e., dysfunctional beliefs and self-efficacy) in the exposure efficacy is examined. The intervention includes eleven sessions including five sessions of exposure in 360-degree videos de-signed especially for each patient difficulties. A multiple single-case design (n=5) is adopted with three types of evaluations: (1) traditional assessment scale of primary/secondary outcomes and aspects related to the therapy, (2) daily ambulatory assessment with a multiple baseline design, (3) experience sampling of cognitive processes about feared situations. Each video will also be assessed by the participants after exposure sessions.

Registry
clinicaltrials.gov
Start Date
January 4, 2021
End Date
October 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Clara DELLA LIBERA

Principal Investigator

University of Liege

Eligibility Criteria

Inclusion Criteria

  • Primary diagnostic (DSM 5) of social anxiety or agoraphobia
  • High level of avoidance
  • French-speaking
  • Having a mobile phone which met VR reading criteria

Exclusion Criteria

  • Having a history of psychotic or bipolar disorder
  • Having a history of severe brain trauma or epilepsy
  • Having a history of respiratory disturbances
  • With a concurrent additional psychotherapy
  • With acute suicidal ideation
  • With a primary diagnosis of depression
  • With a non stabilized medication
  • Auto medication with alcohol or other substances
  • Having migraine or motion sickness

Outcomes

Primary Outcomes

Agoraphobia: avoidance

Time Frame: Follow up : 3 months and 2 weeks after intervention

The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.

Social anxiety: avoidance

Time Frame: Follow up : 3 months and 2 weeks after intervention

The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.

Social anxiety: severity

Time Frame: Follow up : 3 months and 2 week after intervention

The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.

Agoraphobia: Severity

Time Frame: Follow up : 3 months and 2 weeks after intervention

The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.

Multiple measures for change in levels of anxiety

Time Frame: Post-intervention : 1x/day (3 weeks)

A questionnaire comprising four questions regarding the daily rate of avoidant behaviours, approach behaviours, level of anxiety and the severity of anxiety consequences. The questionnaire was sent every day to the participant via a mobile app. Higher scores indicate higher levels of avoidance, approach, anxiety and severity of anxiety consequences.

Secondary Outcomes

  • Therapy outcome(Follow up : 3 months after intervention)
  • Dysfunctional beliefs(Follow up : 3 months after intervention)
  • Multiple measures of transfer and control variables(Post-intervention : 1x/day (3 weeks))
  • Experience sampling method(Post-intervention : spontaneous responses during 2 weeks after intervention)
  • Depression Anxiety and Stress(Follow up : 3 months after intervention)
  • Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself(Follow up : 3 months after intervention)

Study Sites (1)

Loading locations...

Similar Trials