ClinicalTrials.gg
Status unknownNCT04695249Updated Oct 5, 2021

Using 360° Videos in the Treatment of Anxiety Disorders

An interventional study of Exposure intervention using 360 degree videos in Social Anxiety Disorder and Agoraphobia, sponsored by University of Liege. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-05.

Sponsored by University of Liege · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Social Anxiety Disorder
  • Agoraphobia

Keywords

  • 360-degree videos
  • Virtual reality
  • Exposure therapy
  • Anxiety disorders
03

In context

Phobia, Social

367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.

This study's planned enrollment of 5 is below the median of 76 across 338 interventional studies indexed under Phobia, Social.

Browse Phobia, Social studies →

Lead sponsor

University of Liege is the lead sponsor of 251 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Exposure intervention

    Eleven individual sessions.

    Behavioral: Exposure intervention using 360 degree videos

Interventions

  • BehavioralExposure intervention using 360 degree videos

    The intervention consists of eleven sessions. The first five sessions are dedicated to functional assessment and psychoeducation. The second five sessions are dedicated to exposure in 360-degree videos. The last session is provided for relapse prevention.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline : up to 4 weeks before intervention

  2. 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.

    Time frame: Baseline : up to 3 weeks before intervention

  3. 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.

    Time frame: Baseline : up to 2 weeks before intervention

  4. 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.

    Time frame: Post intervention : last day of intervention, week 11

  5. 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.

    Time frame: Post intervention : 1 week after intervention

  6. 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.

    Time frame: Post intervention : 2 week after intervention

  7. 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.

    Time frame: Follow up : Three months after intervention

  8. 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.

    Time frame: Follow up : 3 months and 1 week after intervention

  9. 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.

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

  10. 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.

    Time frame: Baseline : up to 4 weeks before intervention

  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.

    Time frame: Baseline : up to 3 weeks before intervention

  12. 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.

    Time frame: Baseline : up to 2 weeks before intervention

  13. 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.

    Time frame: Post intervention : last day of intervention, week 11

  14. 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.

    Time frame: Post intervention : 1 week after intervention

  15. 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.

    Time frame: Post intervention : 2 week after intervention

  16. 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.

    Time frame: Follow up : 3 months after intervention

  17. 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.

    Time frame: Follow up : 3 months and 1 week after intervention

  18. 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.

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

  19. 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.

    Time frame: Baseline : up to 4 weeks before intervention

  20. 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.

    Time frame: Baseline : up to 3 weeks before intervention

  21. 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.

    Time frame: Baseline : up to 2 weeks before intervention

  22. 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.

    Time frame: Post intervention : last day of intervention, week 11

  23. 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.

    Time frame: Post intervention : 1 week after intervention

  24. 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.

    Time frame: Post intervention : 2 week after intervention

  25. 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.

    Time frame: Follow up : 3 months after intervention

  26. 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.

    Time frame: Follow up : 3 months and 1 week after intervention

  27. 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.

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

  28. 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.

    Time frame: Baseline : up to 4 weeks before intervention

  29. 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.

    Time frame: Baseline : up to 3 weeks before intervention

  30. 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.

    Time frame: Baseline : up to 2 weeks before intervention

  31. 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.

    Time frame: Post intervention : last day of intervention, week 11

  32. 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.

    Time frame: Post intervention : 1 week after intervention

  33. 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.

    Time frame: Post intervention : 2 week after intervention

  34. 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.

    Time frame: Follow up : 3 months after intervention

  35. 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.

    Time frame: Follow up : 3 months and 1 week after intervention

  36. 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.

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

  37. 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.

    Time frame: Baseline : 1x/day (up to 3 week before the intervention)

  38. 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.

    Time frame: Intervention : 1x/day (11weeks)

  39. 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.

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

Secondary outcomes

  1. 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.

    Time frame: Baseline : up to three weeks before intervention

  2. 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.

    Time frame: Post intervention : 1 weeks after intervention

  3. 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.

    Time frame: Follow up : 3 months after intervention

  4. 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").

    Time frame: Baseline : up to three weeks before intervention

  5. 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").

    Time frame: Post intervention : 1 weeks after intervention

  6. 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").

    Time frame: Follow up : 3 months after intervention

  7. 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.

    Time frame: Baseline : up to three weeks before intervention

  8. 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.

    Time frame: Post intervention : 1 weeks after intervention

  9. 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.

    Time frame: Follow up : 3 months after intervention

  10. 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.

    Time frame: Baseline : up to three weeks before intervention

  11. 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.

    Time frame: Post intervention : 1 weeks after intervention

  12. 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.

    Time frame: Follow up : 3 months after intervention

  13. 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.

    Time frame: Baseline : 1x/day (up to three weeks before intervention )

  14. 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.

    Time frame: Intervention : 1x/day (11weeks)

  15. 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.

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

  16. 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.

    Time frame: Baseline : up to 5x/day (up to 21 days)

  17. 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.

    Time frame: Intervention : up to 5x/day (11 weeks)

  18. 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.

    Time frame: Post-intervention : spontaneous responses during 2 weeks after intervention

Other outcomes

  1. Credibility and expectancy of treatment

    The French version of the Credibility and Expectancies Questionnaire (CEQ) was used at pre and post-assessment. The CEQ consists of 6 items that assess (1) the therapy credibility (i.e., the extent to which the treatment makes sense, is believable, convincing and logical) and (2) expectancies towards the therapy (i.e., improvements expected through the intervention). Higher scores indicate higher credibility and positive expectancies towards the treatment. Higher scores indicate higher credibility and positive expectancies towards the treatment.

    Time frame: Baseline : up to three weeks before intervention

  2. Credibility and expectancy of treatment

    The French version of the Credibility and Expectancies Questionnaire (CEQ) was used at pre and post-assessment. The CEQ consists of 6 items that assess (1) the therapy credibility (i.e., the extent to which the treatment makes sense, is believable, convincing and logical) and (2) expectancies towards the therapy (i.e., improvements expected through the intervention). Higher scores indicate higher credibility and positive expectancies towards the treatment. Higher scores indicate higher credibility and positive expectancies towards the treatment.

    Time frame: Post intervention : 1 weeks after intervention

  3. Client Satisfaction towards the treatment

    The Client Satisfaction Questionnaire (CSQ) consists of 8-items that assess client satisfaction with treatment. Higher scores indicate greater client satisfaction and therapeutic alliance. Higher scores indicate higher levels of satisfaction towards the treatment.

    Time frame: Post intervention : 1 weeks after intervention

  4. Helping Alliance

    The Helping Alliance Questionnaire (HAQ) consist of 8-items that assess the quality of the therapeutic alliance. Higher scores indicate greater therapeutic alliance. Higher scores indicate higher levels of therapeutic alliance.

    Time frame: Post intervention : 1 weeks after intervention

  5. Therapy-related evaluation

    A questionnaire including three questions about the therapeutic alliance, therapy credibility, and therapy satisfaction. The participant received the questionnaire once a week on a mobile ap. Higher scores indicate higher satisfaction, credibility and therapeutic alliance.

    Time frame: Intervention phase : 1x/week (11 week)

07

Study locations

1 site
  • University of Liège
    Liège, 4000, Belgium
08

References and documents

Individual participant data

Plan to share: No — Data and analyses will be available from an online repository or from the principal investigator

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04695249
Responsible party
Clara DELLA LIBERA (Principal Investigator, University of Liege) — Principal investigator
First posted
Jan 5, 2021
Start date
Jan 4, 2021
Primary completion
Oct 31, 2021 (estimated)
Completion
Oct 31, 2021 (estimated)
Last update
Oct 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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