CBT With VR Based Exposure for Social Anxiety Disorder

NCT03973541 | Completed

• 1 other identifier: 0001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Social Anxiety

Keywords

Social Anxiety Disorder; Virtual Reality; Exposure Therapy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• change in Social Interaction Anxiety Scale (SIAS)

  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

  change from baseline to week 10

Secondary Outcomes (3)

• Specific Work for Exposure Applied in Therapy (SWEAT).

  week 10

• change in EQ-5D-5L

  change from baseline to week 10

• The Working Alliance Inventory-Short Revised (WAI-SR)

  week 10

Study Arms (3)

Virtual Reality Exposure Therapy

EXPERIMENTAL

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

In Vivo Exposure Therapy

ACTIVE COMPARATOR

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

Virtual Reality Relaxation Therapy

PLACEBO COMPARATOR

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

Interventions

Cognitive Behavioral Therapy with Exposure therapy BEHAVIORAL

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.

In Vivo Exposure Therapy; Virtual Reality Exposure Therapy

Relaxation Therapy BEHAVIORAL

Relaxation Therapy

Virtual Reality Relaxation Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Region of Southern Denmark: lead
• Universite du Quebec en Outaouais: collaborator

Study Sites (1)

Centre for Telepsychiatry

Odense, 5000, Denmark

Location

Related Publications (7)

• Alonso J, Lepine JP; ESEMeD/MHEDEA 2000 Scientific Committee. Overview of key data from the European Study of the Epidemiology of Mental Disorders (ESEMeD). J Clin Psychiatry. 2007;68 Suppl 2:3-9.

  PMID: 17288501 BACKGROUND

• Craske MG, Stein MB. Anxiety. Lancet. 2016 Dec 17;388(10063):3048-3059. doi: 10.1016/S0140-6736(16)30381-6. Epub 2016 Jun 24.

  PMID: 27349358 BACKGROUND

• Stein DJ, Lim CCW, Roest AM, de Jonge P, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Benjet C, Bromet EJ, Bruffaerts R, de Girolamo G, Florescu S, Gureje O, Haro JM, Harris MG, He Y, Hinkov H, Horiguchi I, Hu C, Karam A, Karam EG, Lee S, Lepine JP, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Ten Have M, Torres Y, Viana MC, Wojtyniak B, Xavier M, Kessler RC, Scott KM; WHO World Mental Health Survey Collaborators. The cross-national epidemiology of social anxiety disorder: Data from the World Mental Health Survey Initiative. BMC Med. 2017 Jul 31;15(1):143. doi: 10.1186/s12916-017-0889-2.

  PMID: 28756776 BACKGROUND

• Stein MB, Stein DJ. Social anxiety disorder. Lancet. 2008 Mar 29;371(9618):1115-25. doi: 10.1016/S0140-6736(08)60488-2.

  PMID: 18374843 BACKGROUND

• Kampmann IL, Emmelkamp PM, Morina N. Meta-analysis of technology-assisted interventions for social anxiety disorder. J Anxiety Disord. 2016 Aug;42:71-84. doi: 10.1016/j.janxdis.2016.06.007. Epub 2016 Jun 18.

  PMID: 27376634 BACKGROUND

• Bouchard S, Dumoulin S, Robillard G, Guitard T, Klinger E, Forget H, Loranger C, Roucaut FX. Virtual reality compared with in vivo exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial. Br J Psychiatry. 2017 Apr;210(4):276-283. doi: 10.1192/bjp.bp.116.184234. Epub 2016 Dec 15.

  PMID: 27979818 BACKGROUND

• Clemmensen L, Bouchard S, Rasmussen J, Holmberg TT, Nielsen JH, Jepsen JRM, Lichtenstein MB. STUDY PROTOCOL: 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. BMC Psychiatry. 2020 Jan 30;20(1):32. doi: 10.1186/s12888-020-2453-4.

  PMID: 32000725 DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy; Implosive Therapy; Relaxation Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Desensitization, Psychologic; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Per Trads Ørskov, PhD

  Region of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Assignment will be kept blind for participants and clinicians until the first exposure session.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 4, 2019
• Study Start: December 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: October 26, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)