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Using 360° Videos in the Treatment of Anxiety Disorders

Primary Purpose

Social Anxiety Disorder, Agoraphobia

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exposure intervention using 360 degree videos
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring 360-degree videos, Virtual reality, Exposure therapy, Anxiety disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Liège

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposure intervention

Arm Description

Eleven individual sessions.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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").
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").
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").
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 22, 2020
Last Updated
September 27, 2021
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04695249
Brief Title
Using 360° Videos in the Treatment of Anxiety Disorders
Official Title
Targeting Avoidant Behaviours in Anxiety Disorders Using Individualized 360° Videos: a Multiple Single Case Design
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Agoraphobia
Keywords
360-degree videos, Virtual reality, Exposure therapy, Anxiety disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All assessment pre-post and follow up were realized by an external assessor. The results were blinded to the main psychotherapist (and investigator) until the end of the study.
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure intervention
Arm Type
Experimental
Arm Description
Eleven individual sessions.
Intervention Type
Behavioral
Intervention Name(s)
Exposure intervention using 360 degree videos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social anxiety: avoidance
Description
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.
Time Frame
Baseline : up to 4 weeks before intervention
Title
Social anxiety: avoidance
Description
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.
Time Frame
Baseline : up to 3 weeks before intervention
Title
Social anxiety: avoidance
Description
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.
Time Frame
Baseline : up to 2 weeks before intervention
Title
Social anxiety: avoidance
Description
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.
Time Frame
Post intervention : last day of intervention, week 11
Title
Social anxiety: avoidance
Description
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.
Time Frame
Post intervention : 1 week after intervention
Title
Social anxiety: avoidance
Description
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.
Time Frame
Post intervention : 2 week after intervention
Title
Social anxiety: avoidance
Description
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.
Time Frame
Follow up : Three months after intervention
Title
Social anxiety: avoidance
Description
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.
Time Frame
Follow up : 3 months and 1 week after intervention
Title
Social anxiety: avoidance
Description
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.
Time Frame
Follow up : 3 months and 2 weeks after intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Baseline : up to 4 weeks before intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Baseline : up to 3 weeks before intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Baseline : up to 2 weeks before intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Post intervention : last day of intervention, week 11
Title
Social anxiety: severity
Description
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.
Time Frame
Post intervention : 1 week after intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Post intervention : 2 week after intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Follow up : 3 months after intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Follow up : 3 months and 1 week after intervention
Title
Social anxiety: severity
Description
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.
Time Frame
Follow up : 3 months and 2 week after intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Baseline : up to 4 weeks before intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Baseline : up to 3 weeks before intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Baseline : up to 2 weeks before intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Post intervention : last day of intervention, week 11
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Post intervention : 1 week after intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Post intervention : 2 week after intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Follow up : 3 months after intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Follow up : 3 months and 1 week after intervention
Title
Agoraphobia: avoidance
Description
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.
Time Frame
Follow up : 3 months and 2 weeks after intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Baseline : up to 4 weeks before intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Baseline : up to 3 weeks before intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Baseline : up to 2 weeks before intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Post intervention : last day of intervention, week 11
Title
Agoraphobia: Severity
Description
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.
Time Frame
Post intervention : 1 week after intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Post intervention : 2 week after intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Follow up : 3 months after intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Follow up : 3 months and 1 week after intervention
Title
Agoraphobia: Severity
Description
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.
Time Frame
Follow up : 3 months and 2 weeks after intervention
Title
Multiple measures for change in levels of anxiety
Description
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.
Time Frame
Baseline : 1x/day (up to 3 week before the intervention)
Title
Multiple measures for change in levels of anxiety
Description
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.
Time Frame
Intervention : 1x/day (11weeks)
Title
Multiple measures for change in levels of anxiety
Description
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.
Time Frame
Post-intervention : 1x/day (3 weeks)
Secondary Outcome Measure Information:
Title
Depression Anxiety and Stress
Description
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.
Time Frame
Baseline : up to three weeks before intervention
Title
Depression Anxiety and Stress
Description
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.
Time Frame
Post intervention : 1 weeks after intervention
Title
Depression Anxiety and Stress
Description
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.
Time Frame
Follow up : 3 months after intervention
Title
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
Description
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").
Time Frame
Baseline : up to three weeks before intervention
Title
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
Description
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").
Time Frame
Post intervention : 1 weeks after intervention
Title
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
Description
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").
Time Frame
Follow up : 3 months after intervention
Title
Dysfunctional beliefs
Description
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.
Time Frame
Baseline : up to three weeks before intervention
Title
Dysfunctional beliefs
Description
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.
Time Frame
Post intervention : 1 weeks after intervention
Title
Dysfunctional beliefs
Description
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.
Time Frame
Follow up : 3 months after intervention
Title
Therapy outcome
Description
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.
Time Frame
Baseline : up to three weeks before intervention
Title
Therapy outcome
Description
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.
Time Frame
Post intervention : 1 weeks after intervention
Title
Therapy outcome
Description
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.
Time Frame
Follow up : 3 months after intervention
Title
Multiple measures of transfer and control variables
Description
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.
Time Frame
Baseline : 1x/day (up to three weeks before intervention )
Title
Multiple measures of transfer and control variables
Description
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.
Time Frame
Intervention : 1x/day (11weeks)
Title
Multiple measures of transfer and control variables
Description
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.
Time Frame
Post-intervention : 1x/day (3 weeks)
Title
Experience sampling method
Description
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.
Time Frame
Baseline : up to 5x/day (up to 21 days)
Title
Experience sampling method
Description
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.
Time Frame
Intervention : up to 5x/day (11 weeks)
Title
Experience sampling method
Description
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.
Time Frame
Post-intervention : spontaneous responses during 2 weeks after intervention
Other Pre-specified Outcome Measures:
Title
Credibility and expectancy of treatment
Description
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.
Time Frame
Baseline : up to three weeks before intervention
Title
Credibility and expectancy of treatment
Description
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.
Time Frame
Post intervention : 1 weeks after intervention
Title
Client Satisfaction towards the treatment
Description
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.
Time Frame
Post intervention : 1 weeks after intervention
Title
Helping Alliance
Description
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.
Time Frame
Post intervention : 1 weeks after intervention
Title
Therapy-related evaluation
Description
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.
Time Frame
Intervention phase : 1x/week (11 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data and analyses will be available from an online repository or from the principal investigator

Learn more about this trial

Using 360° Videos in the Treatment of Anxiety Disorders

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