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CBT With VR Based Exposure for Social Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT03973541
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Universite du Quebec en Outaouais
Information provided by (Responsible Party):
Lars Clemmensen, Region of Southern Denmark

Brief Summary:

Social Anxiety Disorder (SAD) is classified as a phobic (anxious) disorder in which the patient experiences anxiety in social interactions, during which he or she might be judged or socially evaluated by others. SAD has an estimated lifetime prevalence of 3-13%, but remains under-treated. The recommended psychological treatment for SAD is is the exposure technique imbedded in Cognitive Behavioral Therapy (CBT). Traditionally exposure has taken place either in vivo or through imaginary exposure. In vivo has shown to be most effective, but it is costly and time-consuming and situational elements, such as the reaction of others, are difficult to control. Recently, researchers and clinicians have started to use Virtual Reality (VR) to overcome such difficulties. Compared to traditional methods VR-based Exposure has several advantages mainly based on increased control.

Meta-analyzes have found superior effect of CBT with VR-based Exposure compared to imaginary exposure, and similar effects when compared to in vivo exposure, with a recent study finding superior effect of VR-based Exposure compared to in vivo. The current evidence thus supports the clinical efficacy of CBT with VR-based Exposure. However, the meta-analyzes include a total of only six randomized controlled trials (RCTs) and only four of these compare CBT with VR-based Exposure to both an in vivo and a control group.

The aims of the current study are to develop a complete program of CBT with VR exposure based on 360° videos for adults suffering from SAD, and to evaluate the treatment effect on SAD symptoms.

The study is designed as a three arm RCT comparing 1) a group receiving CBT with VR-based Exposure, 2) a group receiving CBT with in vivo exposure and 3) a group receiving VR relaxation.

CBT with VR-based Exposure, will include 360° videos with three different scenarios In Vivo Exposure Therapy consists of role-playing and guided exposure either inside or outside the therapist's office.

VR Relaxation Therapy consists of a VR scenario of swimming with dolphins. Treatment will last 10 weeks and there will be a 6 months follow-up.

. It is hypothesized that

  • CBT with VR-based Exposure will reduce symptoms of SAD
  • CBT with VR-based Exposure will be more effective than both CBT with in vivo exposure and VR relaxation therapy at the end of treatment
  • An effect on symptom reduction will sustain at the 6 months follow-up

Condition or disease Intervention/treatment Phase
Social Anxiety Behavioral: Cognitive Behavioral Therapy with Exposure therapy Behavioral: Relaxation Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An equal number of participants will be assigned to each group, but at the end of treatment participants in the third group will be randomly re-allocated to one of the two former groups
Masking: None (Open Label)
Masking Description: Assignment will be kept blind for participants and clinicians until the first exposure session.
Primary Purpose: Treatment
Official Title: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - A Randomized Controlled Superiority Trial Comparing Cognitive Behavioral Therapy With Virtual Reality Based Exposure to Cognitive Behavioral Therapy With in Vivo Exposure.
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Virtual Reality Exposure Therapy
VRET will include 360° videos with three scenarios a) riding a bus, b) going to a school cafeteria and c) a job interview. These scenarios were chosen based on clinical experience and frequently reported difficult situations in the literature . The order of the scenarios is jointly decided by the patient and therapist. In the videos the patients can make choices which determine the further course of the exposure scenario. For example, in the bus scenario the information system is out of order. Therefore, the patient has to ask the driver to announce, when they are at a particular stop. Depending on whether or not the patient decides to do so, the video will skip to one of two alternative continuations of the scenario. During the exposures the therapist will also motivate the patient towards acting in ways they consider unacceptable to provoke fear of ridicule, and make the patient act against him or her excessively rigid rules for social interaction to observe the consequences.
Behavioral: Cognitive Behavioral Therapy with Exposure therapy
Treatment will be conducted for 10 consecutive weekly 60 min sessions. In the first two treatment conditions sessions are scheduled as follows: Session one: Building a therapeutic alliance and psycho-education about social anxiety and safety and avoidance behaviors. Session two to four: Cognitive restructuring. Session five to nine: Exposure in either in vivo or VR. Session 10: Relapse prevention. Sessions one to four and ten are identical in the two of three treatment arms.

Active Comparator: In Vivo Exposure Therapy
In vivo exposure consists of role-playing and guided exposure either inside or outside the therapist's office with active modelling from the therapist in early sessions. Staff members are called upon to conduct exposure. Similarly to the VRET during in vivo exposure the therapist will motivate the patient towards acting in ways they consider unacceptable.
Behavioral: Cognitive Behavioral Therapy with Exposure therapy
Treatment will be conducted for 10 consecutive weekly 60 min sessions. In the first two treatment conditions sessions are scheduled as follows: Session one: Building a therapeutic alliance and psycho-education about social anxiety and safety and avoidance behaviors. Session two to four: Cognitive restructuring. Session five to nine: Exposure in either in vivo or VR. Session 10: Relapse prevention. Sessions one to four and ten are identical in the two of three treatment arms.

Placebo Comparator: Virtual Reality Relaxation Therapy
VR relaxation therapy will consist of a VR scenario of swimming with dolphins, created by the dolphin swim club (www.thedolphinswimclub.com). Swimming with real wild dolphins has been shown to have a positive effect on anxiety, although not specifically on SAD
Behavioral: Relaxation Therapy
Relaxation Therapy




Primary Outcome Measures :
  1. change in Social Interaction Anxiety Scale (SIAS) [ Time Frame: change from baseline to week 10 ]
    Severity of Social Anxiety Disorder. SIAS is a measure of anxiety in social interactional situations and consist of 20 items scored 0-4. The total score range from 0-80 with a score higher than 43 indicating that SAD is probable


Secondary Outcome Measures :
  1. Specific Work for Exposure Applied in Therapy (SWEAT). [ Time Frame: week 10 ]
    The practical and financial resources needed for exposure sessions. SWEAT measures cost and efforts required to conduct exposure sessions. The questionnaire consists of 11 items

  2. change in EQ-5D-5L [ Time Frame: change from baseline to week 10 ]
    General functioning. EQ-5D-5L is a standardized instrument for measuring generic health status.

  3. The Working Alliance Inventory-Short Revised (WAI-SR) [ Time Frame: week 10 ]
    The therapeutic alliance. WAI-SR assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to comprehend the Danish language
  • ≥18 years
  • Fulfill the diagnostic criteria for SAD according to ICD-10 (F40.1) or ICD-11 (6B04)

Exclusion Criteria:

  • Previously diagnosed with psychosis, Autism Spectrum Disorder or severe depression.
  • Participating in other psychotherapeutic treatments during the study
  • Substance dependence disorder
  • Severe cyber-sickness (corresponding to driving sickness).
  • If on medication, medication must be stable for 6 months prior to the study and during the study (i.e., no change).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973541


Contacts
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Contact: Lars Clemmensen, PhD +45 21550216 lars.clemmensen@rsyd.dk
Contact: Mia B Lichtenstein, PhD mialic@rsyd.dk

Sponsors and Collaborators
Region of Southern Denmark
Universite du Quebec en Outaouais
Investigators
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Principal Investigator: Lars Clemmensen, PhD Mental Health Services in the Region of Southern Denmark

Publications:

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Responsible Party: Lars Clemmensen, Post doc, Psychologist. PhD, Region of Southern Denmark
ClinicalTrials.gov Identifier: NCT03973541     History of Changes
Other Study ID Numbers: 0001
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lars Clemmensen, Region of Southern Denmark:
Social Anxiety Disorder
Virtual Reality
Exposure Therapy
Randomized Controlled Trial
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders