Using 360° Videos in the Treatment of Anxiety Disorders

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Social Anxiety Disorder; Agoraphobia
• Intervention / Treatment: Behavioral: Exposure intervention using 360 degree videos

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • University of Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure intervention; Eleven individual sessions.	Behavioral: Exposure intervention using 360 degree videos; The intervention consists of eleven sessions. The first five sessions are dedicated to functional assessment and psychoeducation. The second five sessions are dedicated to exposure in 360-degree videos. The last session is provided for relapse prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social anxiety: avoidance	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.	Baseline : up to 4 weeks before intervention
Social anxiety: avoidance	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.	Baseline : up to 3 weeks before intervention
Social anxiety: avoidance	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.	Baseline : up to 2 weeks before intervention
Social anxiety: avoidance	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.	Post intervention : last day of intervention, week 11
Social anxiety: avoidance	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.	Post intervention : 1 week after intervention
Social anxiety: avoidance	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.	Post intervention : 2 week after intervention
Social anxiety: avoidance	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.	Follow up : Three months after intervention
Social anxiety: avoidance	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.	Follow up : 3 months and 1 week after intervention
Social anxiety: avoidance	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.	Follow up : 3 months and 2 weeks after intervention
Social anxiety: severity	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.	Baseline : up to 4 weeks before intervention
Social anxiety: severity	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.	Baseline : up to 3 weeks before intervention
Social anxiety: severity	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.	Baseline : up to 2 weeks before intervention
Social anxiety: severity	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.	Post intervention : last day of intervention, week 11
Social anxiety: severity	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.	Post intervention : 1 week after intervention
Social anxiety: severity	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.	Post intervention : 2 week after intervention
Social anxiety: severity	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.	Follow up : 3 months after intervention
Social anxiety: severity	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.	Follow up : 3 months and 1 week after intervention
Social anxiety: severity	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.	Follow up : 3 months and 2 week after intervention
Agoraphobia: avoidance	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.	Baseline : up to 4 weeks before intervention
Agoraphobia: avoidance	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.	Baseline : up to 3 weeks before intervention
Agoraphobia: avoidance	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.	Baseline : up to 2 weeks before intervention
Agoraphobia: avoidance	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.	Post intervention : last day of intervention, week 11
Agoraphobia: avoidance	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.	Post intervention : 1 week after intervention
Agoraphobia: avoidance	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.	Post intervention : 2 week after intervention
Agoraphobia: avoidance	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.	Follow up : 3 months after intervention
Agoraphobia: avoidance	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.	Follow up : 3 months and 1 week after intervention
Agoraphobia: avoidance	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.	Follow up : 3 months and 2 weeks after intervention
Agoraphobia: Severity	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.	Baseline : up to 4 weeks before intervention
Agoraphobia: Severity	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.	Baseline : up to 3 weeks before intervention
Agoraphobia: Severity	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.	Baseline : up to 2 weeks before intervention
Agoraphobia: Severity	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.	Post intervention : last day of intervention, week 11
Agoraphobia: Severity	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.	Post intervention : 1 week after intervention
Agoraphobia: Severity	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.	Post intervention : 2 week after intervention
Agoraphobia: Severity	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.	Follow up : 3 months after intervention
Agoraphobia: Severity	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.	Follow up : 3 months and 1 week after intervention
Agoraphobia: Severity	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.	Follow up : 3 months and 2 weeks after intervention
Multiple measures for change in levels of anxiety	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.	Baseline : 1x/day (up to 3 week before the intervention)
Multiple measures for change in levels of anxiety	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.	Intervention : 1x/day (11weeks)
Multiple measures for change in levels of anxiety	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.	Post-intervention : 1x/day (3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Anxiety and Stress	The DASS consists of 21 items assessing (1) depression, (2) anxiety and (3) stress with self-statement. With reference to the last week, all items are rated on a 4-point Likert scale ranging from 0 = "Did not apply to me at all" to 3 "Applied to me very much or most of the time". Scores for each subscale are obtained by summing the scores of relevant items. Higher scores indicate higher level of depression, anxiety and stress.	Baseline : up to three weeks before intervention
Depression Anxiety and Stress	The DASS consists of 21 items assessing (1) depression, (2) anxiety and (3) stress with self-statement. With reference to the last week, all items are rated on a 4-point Likert scale ranging from 0 = "Did not apply to me at all" to 3 "Applied to me very much or most of the time". Scores for each subscale are obtained by summing the scores of relevant items. Higher scores indicate higher level of depression, anxiety and stress.	Post intervention : 1 weeks after intervention
Depression Anxiety and Stress	The DASS consists of 21 items assessing (1) depression, (2) anxiety and (3) stress with self-statement. With reference to the last week, all items are rated on a 4-point Likert scale ranging from 0 = "Did not apply to me at all" to 3 "Applied to me very much or most of the time". Scores for each subscale are obtained by summing the scores of relevant items. Higher scores indicate higher level of 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	A non-validated French version of the ACQ-R was used to assess the participants' perception of control over anxiety and anxiety-related situations (i.e. similar to self-efficacy). The ACQ-R is a 15-items scale assessing the perceived control of (1) emotion (5 items; e.g., "I am able to control my level of anxiety"), (2) threats (6 items; e.g., "There is little I can do to change frightening events") and (3) stress (4 items; e.g., "When I a put under stress, I am likely to lose control").	Baseline : up to three weeks before intervention
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself	A non-validated French version of the ACQ-R was used to assess the participants' perception of control over anxiety and anxiety-related situations (i.e. similar to self-efficacy). The ACQ-R is a 15-items scale assessing the perceived control of (1) emotion (5 items; e.g., "I am able to control my level of anxiety"), (2) threats (6 items; e.g., "There is little I can do to change frightening events") and (3) stress (4 items; e.g., "When I a put under stress, I am likely to lose control").	Post intervention : 1 weeks after intervention
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself	A non-validated French version of the ACQ-R was used to assess the participants' perception of control over anxiety and anxiety-related situations (i.e. similar to self-efficacy). The ACQ-R is a 15-items scale assessing the perceived control of (1) emotion (5 items; e.g., "I am able to control my level of anxiety"), (2) threats (6 items; e.g., "There is little I can do to change frightening events") and (3) stress (4 items; e.g., "When I a put under stress, I am likely to lose control").	Follow up : 3 months after intervention
Dysfunctional beliefs	A non-validated French version of the AABS-2 was used to assess dysfunctional beliefs known to be aetiologically related to anxiety. The AABS-2 consists of 33 beliefs concerning (1) Exposure to judgement, (2) Body vigilance, (3) Thought manifestations and (4) Anxiety. Items are rated on a 7-point Likert scale ranging from 0 to 100 with anchor points at 20, 40, 50, 60, 80%. The four specific scores and one general score are obtained by adding the relevant items. Higher scores indicate greater adherence in beliefs associated with anxiety.	Baseline : up to three weeks before intervention
Dysfunctional beliefs	A non-validated French version of the AABS-2 was used to assess dysfunctional beliefs known to be aetiologically related to anxiety. The AABS-2 consists of 33 beliefs concerning (1) Exposure to judgement, (2) Body vigilance, (3) Thought manifestations and (4) Anxiety. Items are rated on a 7-point Likert scale ranging from 0 to 100 with anchor points at 20, 40, 50, 60, 80%. The four specific scores and one general score are obtained by adding the relevant items. Higher scores indicate greater adherence in beliefs associated with anxiety.	Post intervention : 1 weeks after intervention
Dysfunctional beliefs	A non-validated French version of the AABS-2 was used to assess dysfunctional beliefs known to be aetiologically related to anxiety. The AABS-2 consists of 33 beliefs concerning (1) Exposure to judgement, (2) Body vigilance, (3) Thought manifestations and (4) Anxiety. Items are rated on a 7-point Likert scale ranging from 0 to 100 with anchor points at 20, 40, 50, 60, 80%. The four specific scores and one general score are obtained by adding the relevant items. Higher scores indicate greater adherence in beliefs associated with anxiety.	Follow up : 3 months after intervention
Therapy outcome	The French version of the outcome Questionnaire was used to assess clinical changes in participants. The MI-45 consists of 45 items that assess (1) intrapsychic symptoms of distress (i.e., 25 items, symptoms of depression and anxiety) (2) interpersonal relationship, (i.e., 11 items, satisfaction and difficulties during social interactions) and (3) social roles performance (i.e., 9 items, level of dissatisfaction, conflict, distress and incompetence related to employment, family and hobbies). All items are rated on a 5-point Likert scale ranging from 0 = Never to 4 = Almost Always. The total score ranging from 0 to 80 and the three specific scores can be obtained by adding the relevant items. In addition, the scale possesses a clinical threshold of 63 and a "reliable clinical change" starting from a 17-points gain or loss.	Baseline : up to three weeks before intervention
Therapy outcome	The French version of the outcome Questionnaire was used to assess clinical changes in participants. The MI-45 consists of 45 items that assess (1) intrapsychic symptoms of distress (i.e., 25 items, symptoms of depression and anxiety) (2) interpersonal relationship, (i.e., 11 items, satisfaction and difficulties during social interactions) and (3) social roles performance (i.e., 9 items, level of dissatisfaction, conflict, distress and incompetence related to employment, family and hobbies). All items are rated on a 5-point Likert scale ranging from 0 = Never to 4 = Almost Always. The total score ranging from 0 to 80 and the three specific scores can be obtained by adding the relevant items. In addition, the scale possesses a clinical threshold of 63 and a "reliable clinical change" starting from a 17-points gain or loss.	Post intervention : 1 weeks after intervention
Therapy outcome	The French version of the outcome Questionnaire was used to assess clinical changes in participants. The MI-45 consists of 45 items that assess (1) intrapsychic symptoms of distress (i.e., 25 items, symptoms of depression and anxiety) (2) interpersonal relationship, (i.e., 11 items, satisfaction and difficulties during social interactions) and (3) social roles performance (i.e., 9 items, level of dissatisfaction, conflict, distress and incompetence related to employment, family and hobbies). All items are rated on a 5-point Likert scale ranging from 0 = Never to 4 = Almost Always. The total score ranging from 0 to 80 and the three specific scores can be obtained by adding the relevant items. In addition, the scale possesses a clinical threshold of 63 and a "reliable clinical change" starting from a 17-points gain or loss.	Follow up : 3 months after intervention
Multiple measures of transfer and control variables	A questionnaire comprising 13 questions regarding the daily rate of positive and negative affects, the specific objective of the participant and control. The questionnaire was sent every day to the participant via a mobile app.	Baseline : 1x/day (up to three weeks before intervention )
Multiple measures of transfer and control variables	A questionnaire comprising 13 questions regarding the daily rate of positive and negative affects, the specific objective of the participant and control. The questionnaire was sent every day to the participant via a mobile app.	Intervention : 1x/day (11weeks)
Multiple measures of transfer and control variables	A questionnaire comprising 13 questions regarding the daily rate of positive and negative affects, the specific objective of the participant and control. The questionnaire was sent every day to the participant via a mobile app.	Post-intervention : 1x/day (3 weeks)
Experience sampling method	Questionaire including 8 to 11 questions (3 conditioned) regarding the nature, response and appraisal of anxious situations. Participants were asked to reply to the questionnaire on a mobile app when facing feared situations.	Baseline : up to 5x/day (up to 21 days)
Experience sampling method	Questionaire including 8 to 11 questions (3 conditioned) regarding the nature, response and appraisal of anxious situations. Participants were asked to reply to the questionnaire on a mobile app when facing feared situations.	Intervention : up to 5x/day (11 weeks)
Experience sampling method	Questionaire including 8 to 11 questions (3 conditioned) regarding the nature, response and appraisal of anxious situations. Participants were asked to reply to the questionnaire on a mobile app when facing feared situations.	Post-intervention : spontaneous responses during 2 weeks after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility and expectancy of treatment	The French version of the Credibility and Expectancies Questionnaire (CEQ) was used at pre and post-assessment. The CEQ consists of 6 items that assess (1) the therapy credibility (i.e., the extent to which the treatment makes sense, is believable, convincing and logical) and (2) expectancies towards the therapy (i.e., improvements expected through the intervention). Higher scores indicate higher credibility and positive expectancies towards the treatment. Higher scores indicate higher credibility and positive expectancies towards the treatment.	Baseline : up to three weeks before intervention
Credibility and expectancy of treatment	The French version of the Credibility and Expectancies Questionnaire (CEQ) was used at pre and post-assessment. The CEQ consists of 6 items that assess (1) the therapy credibility (i.e., the extent to which the treatment makes sense, is believable, convincing and logical) and (2) expectancies towards the therapy (i.e., improvements expected through the intervention). Higher scores indicate higher credibility and positive expectancies towards the treatment. Higher scores indicate higher credibility and positive expectancies towards the treatment.	Post intervention : 1 weeks after intervention
Client Satisfaction towards the treatment	The Client Satisfaction Questionnaire (CSQ) consists of 8-items that assess client satisfaction with treatment. Higher scores indicate greater client satisfaction and therapeutic alliance. Higher scores indicate higher levels of satisfaction towards the treatment.	Post intervention : 1 weeks after intervention
Helping Alliance	The Helping Alliance Questionnaire (HAQ) consist of 8-items that assess the quality of the therapeutic alliance. Higher scores indicate greater therapeutic alliance. Higher scores indicate higher levels of therapeutic alliance.	Post intervention : 1 weeks after intervention
Therapy-related evaluation	A questionnaire including three questions about the therapeutic alliance, therapy credibility, and therapy satisfaction. The participant received the questionnaire once a week on a mobile ap. Higher scores indicate higher satisfaction, credibility and therapeutic alliance.	Intervention phase : 1x/week (11 week)

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 1, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Virtual reality; Anxiety disorders; Exposure therapy; 360-degree videos
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social; Agoraphobia
• Other Study ID Numbers: 2021-360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data and analyses will be available from an online repository or from the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No