Virtual Reality for AnxIety Disorders - Randomized Controlled Trial

NCT05302518 | Completed DMC

• 2 other identifiers: 21/598709069-00043B
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Social anxiety disorder (SAD) has a high prevalence and an early onset and has a lengthy recovery period often taking decades to occur. Current evidence supports the efficacy of cognitive behavioral therapy (CBT) with virtual reality (VR) exposure. However, the evidence is based on a small number of studies. This trial examines the efficacy of an intervention that combines CBT with individually tailored exposure in VR. During exposure, participants' anxiety level is estimated in real time based on heart rate and electrodermal activity. Estimated anxiety level can guide the therapist's adjustment of the VR content. The above treatment is compared with the gold standard treatment for SAD which is cognitive behavioral therapy with exposure conducted in real life. Treatment is individual, manual-based and consists of 10 weekly sessions with a duration of 60 minutes. The aim of the study is to investigate whether CBT combined with exposure in VR (adapted on the basis of estimated anxiety level) is more effective than CBT with exposure in real life. The trial is a randomized controlled trail (RCT). The study includes 90 participants diagnosed with SAD. Assessments are carried out pre-treatment, mid-treatment and at follow-up (6 and 12 months). The primary outcome of the study is self-reported symptoms of social anxiety using Social Interaction Anxiety Scale. The primary endpoint is post-treatment.

Conditions

Social Anxiety; Social Phobia

Keywords

Social anxiety; Cognitive behavioral therapy; Virtual reality; Exposure; Psychophysiological Measurement; Heart Rate; Electrodermal Activity

Outcome Measures

Primary Outcomes (1)

• Social Anxiety Interaction Scale

  The instrument is a measure of social anxiety symptoms and consists of 20 items assessing cognitive, affective, and behavioral responses to social interaction. The scale ranges from 0 to 80. Higher scores indicate worse outcome. Participants have to indicate to what degree they feel each statement is characteristic to them using a 5-point Likert scale (0 = not at all, 1 = slightly, 2 = moderately, 3 = very, 4 = extremely). The instrument has high internal consistency, Cronbach's alpha = 0.93, and high test-retest reliability, r = 0.92 (45).

  post-treatment (week 10)

Secondary Outcomes (6)

• Leibowitz Anxiety Scale - Self report version

  post-treatment (week 10)

• Fear of Negative Evaluation - Brief version

  post-treatment (week 10)

• Major Depression inventory

  post-treatment (week 10)

• EQ-5D-5L

  post-treatment (week 10)

• Alcohol Use Disorders Identification Test

  pre-treatment (week 1)

Study Arms (2)

Cognitive behavioral therapy with exposure in virtual reality

EXPERIMENTAL

This arm of the study will receive cognitive behavioral therapy with exposure in virtual reality. The intervention is individual and manualized and delivered by a psychologist. The intervention consists of 10 weekly session with a duration of 60 minutes. Exposure is conducted from session 4 to 9. Homework is assigned and it includes exposure in vivo. The amount of exposure is controlled for.

Behavioral: Cognitive behavioral therapy with exposure in virtual reality

Cognitive behavioral therapy with exposure in vivo

ACTIVE COMPARATOR

This arm of the study will receive cognitive behavioral therapy with exposure in vivo. The intervention is individual and manualized and delivered by a psychologist. The intervention consists of 10 weekly session with a duration of 60 minutes. Exposure is conducted from session 4 to 9. Homework is assigned and it includes exposure in vivo. The amount of exposure is controlled for.

Behavioral: Cognitive behavioral therapy with exposure in vivo

Interventions

Cognitive behavioral therapy with exposure in virtual reality BEHAVIORAL

The treatment rationale is based on a model of the maintenance of social phobia by Clark and Wells. The themes of therapy are: a) The general ideas of CBT, b) The maintaining processes of social phobia, c) negative automatic thoughts, d) shifting focus of attention form self-focus to external focus, e) safety behaviors, f) post-processing, g) self-processing, h) schemas and rules for living. Exposure in VR: We will use 360° 3D videos for exposure using an HTC Vive Pro headset. Six different videos will be used for exposure: 1) Taking a seat on a bench in a public park, 2) Being introduced as a new employee, 3) Performing a presentation at a meeting, 4) Entering and shopping in a grocery store, 5) Visiting a café and 6) Using public transportation. The therapist can choose the length of the exposure as well as the difficulty of the exposure. While the participant is in the VR-scenario HR and EDA are measured. These data are collected to continuously estimate the anxiety levels.

Also known as: CBT-ExpVR

Cognitive behavioral therapy with exposure in virtual reality

Cognitive behavioral therapy with exposure in vivo BEHAVIORAL

The treatment rationale is based on a model of the maintenance of social phobia by Clark and Wells.The themes of therapy are: a) The general ideas of CBT, b) The maintaining processes of social phobia, c) negative automatic thoughts, d) shifting focus of attention form self-focus to external focus, e) safety behaviors, f) post-processing, g) self-processing, h) schemas and rules for living. Exposure in vivo: Exposure is taking place at Centre for Telepsychiatry and the surrounding areas. The therapist is planning the exposure with the participant and is accompanying the participant during the exposure.

Also known as: CBT-Exp

Cognitive behavioral therapy with exposure in vivo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sufficient knowledge of the Danish Language.
• Fulfilling the diagnostic criteria for SAD according to ICD-10 classification of mental and behavioral disorders (F 40.1).

You may not qualify if:

• Previously diagnosed with autism spectrum disorders.
• Previously diagnosed with psychotic disorders.
• Severe depression (\>29 Major Depression Inventory)
• Dependence syndrome
• Suicidal ideation.
• Dementia/Intellectual disability.
• Epilepsy.
• Taking part in other kinds of psychological intervention for SAD.

Sponsors & Collaborators

• Region of Southern Denmark: lead
• University of Southern Denmark: collaborator
• Odense University Hospital: collaborator
• Universite du Quebec en Outaouais: collaborator
• IMotions A/S: collaborator

Study Sites (1)

Centre for Telepsychiatry

Odense C, Denmark/Region of Southern Denmark, 5000, Denmark

Location

Related Publications (17)

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  BACKGROUND

• Ruscio AM, Brown TA, Chiu WT, Sareen J, Stein MB, Kessler RC. Social fears and social phobia in the USA: results from the National Comorbidity Survey Replication. Psychol Med. 2008 Jan;38(1):15-28. doi: 10.1017/S0033291707001699. Epub 2007 Nov 2.

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  PMID: 10713800 BACKGROUND

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  PMID: 27979818 BACKGROUND

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• Olsen LR, Jensen DV, Noerholm V, Martiny K, Bech P. The internal and external validity of the Major Depression Inventory in measuring severity of depressive states. Psychol Med. 2003 Feb;33(2):351-6. doi: 10.1017/s0033291702006724.

  PMID: 12622314 BACKGROUND

• Mattick RP, Clarke JC. Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. Behav Res Ther. 1998 Apr;36(4):455-70. doi: 10.1016/s0005-7967(97)10031-6.

  PMID: 9670605 BACKGROUND

• Tavoli A, Melyani M, Bakhtiari M, Ghaedi GH, Montazeri A. The Brief Fear of Negative Evaluation Scale (BFNE): translation and validation study of the Iranian version. BMC Psychiatry. 2009 Jul 9;9:42. doi: 10.1186/1471-244X-9-42.

  PMID: 19589161 BACKGROUND

• Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.

  PMID: 8329970 BACKGROUND

• Hildebrand M. The Psychometric Properties of the Drug Use Disorders Identification Test (DUDIT): A Review of Recent Research. J Subst Abuse Treat. 2015 Jun;53:52-9. doi: 10.1016/j.jsat.2015.01.008. Epub 2015 Jan 31.

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• Kennedy, R. S., Lane, N. E., Berbaum, K. S., & Lilienthal, M. G. (1993). Simulator Sickness Questionnaire: An enhanced method for quantifying simulator sickness. The International Journal of Aviation Psychology, 3(3), 203-220. https://doi.org/10.1207/s15327108ijap0303_3

  BACKGROUND

• Horvath, A. O., & Greenberg, L. S. (1989). Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology, 36(2), 223-233. https://doi.org/10.1037/0022-0167.36.2.223

  BACKGROUND

• Robillard G, Bouchard S, Dumoulin S, Guitard T. The development of the SWEAT questionnaire: a scale measuring costs and efforts inherent to conducting exposure sessions. Stud Health Technol Inform. 2011;167:105-10.

  PMID: 21685650 BACKGROUND

• Orskov PT, Lichtenstein MB, Ernst MT, Fasterholdt I, Matthiesen AF, Scirea M, Bouchard S, Andersen TE. Cognitive behavioral therapy with adaptive virtual reality exposure vs. cognitive behavioral therapy with in vivo exposure in the treatment of social anxiety disorder: A study protocol for a randomized controlled trial. Front Psychiatry. 2022 Oct 10;13:991755. doi: 10.3389/fpsyt.2022.991755. eCollection 2022.

  PMID: 36299540 DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Per Trads Ørskov, Ph.d.

  Region of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 31, 2022
• Study Start: March 31, 2022
• Primary Completion: January 4, 2025
• Study Completion: January 4, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: February 2025
• Access Criteria: Restrictions apply to the availability of data and approval is needed from Danish Data Protection Agency and or The Danish National Archives.

Locations

DK (1)