Clinical trial NCT04695249: Using 360° Videos in the Treatment of Anxiety Disorders
Official title: Targeting Avoidant Behaviours in Anxiety Disorders Using Individualized 360° Videos: a Multiple Single Case Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety Disorder
Agoraphobia
Keywords: 360-degree videos
Virtual reality
Exposure therapy
Anxiety disorders
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: There is growing evidence that supports the use of Virtual Reality (VR) to address anxiety disorders such as social anxiety and agoraphobia. The main advantage of VR is to expose participants to their fears in a controlled and safe environment. However, the access to VR remains costly for health professionals who need to pay licenses for the use of a limited number of environments. Therefore, these standardized environments only address the symptoms of standard anxious patients. As a way to provide an accessible tool that can be tailored according to patients' specific difficulties, the proposed approach builds on 360-degree videos as an alternative to VR.

The aim of the present study is to test the feasibility and efficacy of an individualized expo-sure intervention using 360-degree videos. In addition, the role of cognitive processes (i.e., dysfunctional beliefs and self-efficacy) in the exposure efficacy is examined. The intervention includes eleven sessions including five sessions of exposure in 360-degree videos de-signed especially for each patient difficulties.

A multiple single-case design (n=5) is adopted with three types of evaluations: (1) traditional assessment scale of primary/secondary outcomes and aspects related to the therapy, (2) daily ambulatory assessment with a multiple baseline design, (3) experience sampling of cognitive processes about feared situations.

Each video will also be assessed by the participants after exposure sessions.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Social anxiety: avoidance
timeFrame: Baseline : up to 4 weeks before intervention
measure: Social anxiety: avoidance
timeFrame: Baseline : up to 3 weeks before intervention
measure: Social anxiety: avoidance
timeFrame: Baseline : up to 2 weeks before intervention
measure: Social anxiety: avoidance
timeFrame: Post intervention : last day of intervention, week 11
measure: Social anxiety: avoidance
timeFrame: Post intervention : 1 week after intervention
measure: Social anxiety: avoidance
timeFrame: Post intervention : 2 week after intervention
measure: Social anxiety: avoidance
timeFrame: Follow up : Three months after intervention
measure: Social anxiety: avoidance
timeFrame: Follow up : 3 months and 1 week after intervention
measure: Social anxiety: avoidance
timeFrame: Follow up : 3 months and 2 weeks after intervention
measure: Social anxiety: severity
timeFrame: Baseline : up to 4 weeks before intervention
measure: Social anxiety: severity
timeFrame: Baseline : up to 3 weeks before intervention
measure: Social anxiety: severity
timeFrame: Baseline : up to 2 weeks before intervention
measure: Social anxiety: severity
timeFrame: Post intervention : last day of intervention, week 11
measure: Social anxiety: severity
timeFrame: Post intervention : 1 week after intervention
measure: Social anxiety: severity
timeFrame: Post intervention : 2 week after intervention
measure: Social anxiety: severity
timeFrame: Follow up : 3 months after intervention
measure: Social anxiety: severity
timeFrame: Follow up : 3 months and 1 week after intervention
measure: Social anxiety: severity
timeFrame: Follow up : 3 months and 2 week after intervention
measure: Agoraphobia: avoidance
timeFrame: Baseline : up to 4 weeks before intervention
measure: Agoraphobia: avoidance
timeFrame: Baseline : up to 3 weeks before intervention
measure: Agoraphobia: avoidance
timeFrame: Baseline : up to 2 weeks before intervention
measure: Agoraphobia: avoidance
timeFrame: Post intervention : last day of intervention, week 11
measure: Agoraphobia: avoidance
timeFrame: Post intervention : 1 week after intervention
measure: Agoraphobia: avoidance
timeFrame: Post intervention : 2 week after intervention
measure: Agoraphobia: avoidance
timeFrame: Follow up : 3 months after intervention
measure: Agoraphobia: avoidance
timeFrame: Follow up : 3 months and 1 week after intervention
measure: Agoraphobia: avoidance
timeFrame: Follow up : 3 months and 2 weeks after intervention
measure: Agoraphobia: Severity
timeFrame: Baseline : up to 4 weeks before intervention
measure: Agoraphobia: Severity
timeFrame: Baseline : up to 3 weeks before intervention
measure: Agoraphobia: Severity
timeFrame: Baseline : up to 2 weeks before intervention
measure: Agoraphobia: Severity
timeFrame: Post intervention : last day of intervention, week 11
measure: Agoraphobia: Severity
timeFrame: Post intervention : 1 week after intervention
measure: Agoraphobia: Severity
timeFrame: Post intervention : 2 week after intervention
measure: Agoraphobia: Severity
timeFrame: Follow up : 3 months after intervention
measure: Agoraphobia: Severity
timeFrame: Follow up : 3 months and 1 week after intervention
measure: Agoraphobia: Severity
timeFrame: Follow up : 3 months and 2 weeks after intervention
measure: Multiple measures for change in levels of anxiety
timeFrame: Baseline : 1x/day (up to 3 week before the intervention)
measure: Multiple measures for change in levels of anxiety
timeFrame: Intervention : 1x/day (11weeks)
measure: Multiple measures for change in levels of anxiety
timeFrame: Post-intervention : 1x/day (3 weeks)
Secondary outcomes:
measure: Depression Anxiety and Stress
timeFrame: Baseline : up to three weeks before intervention
measure: Depression Anxiety and Stress
timeFrame: Post intervention : 1 weeks after intervention
measure: Depression Anxiety and Stress
timeFrame: Follow up : 3 months after intervention
measure: Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
timeFrame: Baseline : up to three weeks before intervention
measure: Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
timeFrame: Post intervention : 1 weeks after intervention
measure: Self-efficacy toward managing the situation, the occurrence of the feared outcome and the fear itself
timeFrame: Follow up : 3 months after intervention
measure: Dysfunctional beliefs
timeFrame: Baseline : up to three weeks before intervention
measure: Dysfunctional beliefs
timeFrame: Post intervention : 1 weeks after intervention
measure: Dysfunctional beliefs
timeFrame: Follow up : 3 months after intervention
measure: Therapy outcome
timeFrame: Baseline : up to three weeks before intervention
measure: Therapy outcome
timeFrame: Post intervention : 1 weeks after intervention
measure: Therapy outcome
timeFrame: Follow up : 3 months after intervention
measure: Multiple measures of transfer and control variables
timeFrame: Baseline : 1x/day (up to three weeks before intervention )
measure: Multiple measures of transfer and control variables
timeFrame: Intervention : 1x/day (11weeks)
measure: Multiple measures of transfer and control variables
timeFrame: Post-intervention : 1x/day (3 weeks)
measure: Experience sampling method
timeFrame: Baseline : up to 5x/day (up to 21 days)
measure: Experience sampling method
timeFrame: Intervention : up to 5x/day (11 weeks)
measure: Experience sampling method
timeFrame: Post-intervention : spontaneous responses during 2 weeks after intervention
Other outcomes:
measure: Credibility and expectancy of treatment
timeFrame: Baseline : up to three weeks before intervention
measure: Credibility and expectancy of treatment
timeFrame: Post intervention : 1 weeks after intervention
measure: Client Satisfaction towards the treatment
timeFrame: Post intervention : 1 weeks after intervention
measure: Helping Alliance
timeFrame: Post intervention : 1 weeks after intervention
measure: Therapy-related evaluation
timeFrame: Intervention phase : 1x/week (11 week)
Locations:
city: Liège
country: Belgium
facility: University of Liège
Study officials:
References: