Social Anxiety DisorderNCT04695249
Using 360° Videos in the Treatment of Anxiety Disorders
A study testing Exposure intervention using 360 degree videos in people with Social Anxiety Disorder and Agoraphobia, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder, Agoraphobia
- What is being tested?
- Exposure intervention using 360 degree videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jan 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnostic (DSM 5) of social anxiety or agoraphobia
- High level of avoidance
- French-speaking
- Having a mobile phone which met VR reading criteria
Who cannot join
- 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
Show all 9Show fewer
- With a non stabilized medication
- Auto medication with alcohol or other substances
- Having migraine or motion sickness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety Disorder, Agoraphobia
- Being tested
- Exposure intervention using 360 degree videos
- Keywords
- 360-degree videos, Virtual reality, Exposure therapy, Anxiety disorders
- Medical subject headings
- Phobia, Social, Agoraphobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure intervention using 360 degree videosBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure intervention | Experimental | Eleven individual sessions. Receives: Behavioral: Exposure intervention using 360 degree videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention : 1x/day (3 weeks)
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention : spontaneous responses during 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start4 Jan 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara DELLA LIBERA, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695249
- Sponsor's protocol ID
- 2021-360
- Status last verified
- Sep 2021
- First submitted
- 22 Dec 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data and analyses will be available from an online repository or from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Avoidant Behaviours in Anxiety Disorders Using Individualized 360° Videos: a Multiple Single Case Design
- ClinicalTrials.gov ID
- NCT04695249
- Acronym / sponsor ID
- 2021-360
- Conditions
- Social Anxiety Disorder, Agoraphobia
- Keywords
- 360-degree videos, Virtual reality, Exposure therapy, Anxiety disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure intervention | Experimental | Behavioral: Exposure intervention using 360 degree videosEleven individual sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary diagnostic (DSM 5) of social anxiety or agoraphobia
- High level of avoidance
- French-speaking
- Having a mobile phone which met VR reading criteria
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure intervention using 360 degree videosThe 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. | Behavioural | Exposure intervention |
Primary outcome
Social anxiety: avoidance
Time frame: Baseline : up to 4 weeks before intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: avoidance
Time frame: Baseline : up to 3 weeks before intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: avoidance
Time frame: Baseline : up to 2 weeks before intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: avoidance
Time frame: Post intervention : last day of intervention, week 11
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
Time frame: Post intervention : 1 week after intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: avoidance
Time frame: Post intervention : 2 week after intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: avoidance
Time frame: Follow up : Three months after intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: avoidance
Time frame: Follow up : 3 months and 1 week after intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: avoidance
Time frame: Follow up : 3 months and 2 weeks after intervention
The French version of the LSAS-SR was used to assess the levels of anxiety and avoidance associated with social situations. The LSAS-SR consists of 24 items describing four types of situations: (1) social interactions, (2) public speaking, (3) eating and drinking in public, (4) being observed. Each item is rated on a 3-point scale according to both the level of fear (0 = "no fear" to 3 = "severe") and the level of avoidance (0 = "never" to 3 = "Usually"). A general total score can be obtained by summing all items and specific score of avoidance and fear as well as scores for specific type of situations can be obtained by summing specific items.
Social anxiety: severity
Time frame: Baseline : up to 4 weeks before intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Social anxiety: severity
Time frame: Baseline : up to 3 weeks before intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Social anxiety: severity
Time frame: Baseline : up to 2 weeks before intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Social anxiety: severity
Time frame: Post intervention : last day of intervention, week 11
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
Time frame: Post intervention : 1 week after intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Social anxiety: severity
Time frame: Post intervention : 2 week after intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Social anxiety: severity
Time frame: Follow up : 3 months after intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Social anxiety: severity
Time frame: Follow up : 3 months and 1 week after intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Social anxiety: severity
Time frame: Follow up : 3 months and 2 week after intervention
The French version of the SIAS was used to assess social anxiety severity. The SIAS consists of 20 self-statements describing one's reaction to situations that involve social interaction. Each item is rated on a 4-point Likert scale ranging from 0 = "not at all characteristic or true of me" to 4 "extremely characteristic or true of me". The SIAS is scored by summing the ratings. Total score ranges from 0 to 80, with higher scores representing higher levels of social interaction anxiety.
Agoraphobia: avoidance
Time frame: Baseline : up to 4 weeks before intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: avoidance
Time frame: Baseline : up to 3 weeks before intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: avoidance
Time frame: Baseline : up to 2 weeks before intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: avoidance
Time frame: Post intervention : last day of intervention, week 11
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
Time frame: Post intervention : 1 week after intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: avoidance
Time frame: Post intervention : 2 week after intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: avoidance
Time frame: Follow up : 3 months after intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: avoidance
Time frame: Follow up : 3 months and 1 week after intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: avoidance
Time frame: Follow up : 3 months and 2 weeks after intervention
The French version of the MIA was used to assess the levels of agoraphobic avoidance. The MIA consists of 25 items describing agoraphobic situations. Each item is rated according to the level of avoidance on a 5-point Likert scale ranging from 1 = "never avoid" to 5 = "always avoid", both when the participants are accompanied or alone. One final question concerns the number of panic attacks during the last week. The MIA provides a score for situations alone or accompanied by summing the ratings. Higher scores indicate higher levels of avoidance.
Agoraphobia: Severity
Time frame: Baseline : up to 4 weeks before intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Agoraphobia: Severity
Time frame: Baseline : up to 3 weeks before intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Agoraphobia: Severity
Time frame: Baseline : up to 2 weeks before intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Agoraphobia: Severity
Time frame: Post intervention : last day of intervention, week 11
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
Time frame: Post intervention : 1 week after intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Agoraphobia: Severity
Time frame: Post intervention : 2 week after intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Agoraphobia: Severity
Time frame: Follow up : 3 months after intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Agoraphobia: Severity
Time frame: Follow up : 3 months and 1 week after intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Agoraphobia: Severity
Time frame: Follow up : 3 months and 2 weeks after intervention
The French version of the Panic and Agoraphobia Scale consists of 13 items divided in five subscales: (1) panic attacks, (2) agoraphobia, (3) anticipatory anxiety, (4) interference with family/hobbies/working and (5) worries about health. Each item is rated on a specific 5-point scale, with higher scores indicating higher severity. The PAS is scored by summing the subscales and all items with a total score ranging from 13 to 52.
Multiple measures for change in levels of anxiety
Time frame: Baseline : 1x/day (up to 3 week before the intervention)
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
Time frame: Intervention : 1x/day (11weeks)
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
Time frame: Post-intervention : 1x/day (3 weeks)
A questionnaire comprising four questions regarding the daily rate of avoidant behaviours, approach behaviours, level of anxiety and the severity of anxiety consequences. The questionnaire was sent every day to the participant via a mobile app. Higher scores indicate higher levels of avoidance, approach, anxiety and severity of anxiety consequences.
18 secondary outcomes
Depression Anxiety and Stress
Time frame: Baseline : up to three weeks before intervention
Depression Anxiety and Stress
Time frame: Post intervention : 1 weeks after intervention
Depression Anxiety and Stress
Time frame: Follow up : 3 months after intervention
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
Time frame: Baseline : up to three weeks before intervention
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
Time frame: Post intervention : 1 weeks after intervention
Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
Time frame: Follow up : 3 months after intervention
Dysfunctional beliefs
Time frame: Baseline : up to three weeks before intervention
Dysfunctional beliefs
Time frame: Post intervention : 1 weeks after intervention
Dysfunctional beliefs
Time frame: Follow up : 3 months after intervention
Therapy outcome
Time frame: Baseline : up to three weeks before intervention
Therapy outcome
Time frame: Post intervention : 1 weeks after intervention
Therapy outcome
Time frame: Follow up : 3 months after intervention
Multiple measures of transfer and control variables
Time frame: Baseline : 1x/day (up to three weeks before intervention )
Multiple measures of transfer and control variables
Time frame: Intervention : 1x/day (11weeks)
Multiple measures of transfer and control variables
Time frame: Post-intervention : 1x/day (3 weeks)
Experience sampling method
Time frame: Baseline : up to 5x/day (up to 21 days)
Experience sampling method
Time frame: Intervention : up to 5x/day (11 weeks)
Experience sampling method
Time frame: Post-intervention : spontaneous responses during 2 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No. Data and analyses will be available from an online repository or from the principal investigator
Related trials for Social Anxiety Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure intervention using 360 degree videos in people with Social Anxiety Disorder and Agoraphobia, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social anxiety: avoidance (time frame: Baseline : up to 4 weeks before intervention). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.