Reducing Social Avoidance Among Adolescents With Special Educational Needs

NCT ID: NCT06450665

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2025-05-31

Brief Summary

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The goal of this clinical trial is to examine the effectiveness of a Virtual Reality (VR) social avoidance intervention in reducing social avoidance symptoms among adolescents with special educational needs. Participants will complete tasks in the VR scenario with increasing difficulty and learn that they can cope in situations that they previously avoid. We hypothesize that, comparing with usual care (i.e. waitlist control), the intervention group will experience a significant reduction on social avoidance symptoms after treatment and this benefit will persist till 1-month follow-up.

Detailed Description

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Over the past 25 years, VR has been used to complement therapist-delivered psychological interventions, primarily exposure therapy for anxiety related disorders. VR renders real-world social interactions simulation, which allows users to experience an anxiety provoking situation with a greater sense of control. In Hong Kong, with the lack of mental health professionals being a perennial problem, VR-based interventions offer the potential to substantially reduce the treatment time and cost, as well as to increase access to evidence-based psychological interventions.

The Virtual Reality (VR) social avoidance intervention used in the current study is designed based on cognitive-behavioral approach with a virtual coach acting as the therapist. It is designed in tandem with input from Hong Kong users to ensure the scenario can resonate with them.

Conditions

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Social Avoidant Behavior Social Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention group will go through three 30-minute VR sessions over a period of 3 weeks. The wait-list control group will complete the questionnaires in the same interval as the intervention group, with promise of receiving VR intervention after 1-month follow-up is over.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VR Social Avoidance Intervention

The intervention group will go through three 30-minute VR sessions over a period of 3 weeks. Participants will need to complete a baseline survey before the VR sessions and a post-intervention survey after the VR sessions, as well as a 1-month follow-up survey.

Group Type EXPERIMENTAL

VR Social Avoidance Intervention

Intervention Type BEHAVIORAL

The intervention is based on cognitive-behavioral approach with a virtual coach acting as the therapist. It will be designed in tandem with input from Hong Kong users to ensure the scenario can resonate with them. By testing beliefs that inhibit confidence in a safe and controlled environment, participants will complete tasks with increasing difficulty in three VR scenarios and learn that they can cope in situations that they previously avoid.

Waitlist Control

The wait-list control group will complete the questionnaires in the same interval as the intervention group, with promise of receiving VR intervention after 1-month follow-up is over.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VR Social Avoidance Intervention

The intervention is based on cognitive-behavioral approach with a virtual coach acting as the therapist. It will be designed in tandem with input from Hong Kong users to ensure the scenario can resonate with them. By testing beliefs that inhibit confidence in a safe and controlled environment, participants will complete tasks with increasing difficulty in three VR scenarios and learn that they can cope in situations that they previously avoid.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 16-19
* Can read traditional Chinese and understand Cantonese
* Self-report on experiencing social avoidance symptoms

Exclusion Criteria

* History of photosensitive epilepsy
* Impairment of stereoscopic vision
* Balance problems
Minimum Eligible Age

16 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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CHEN Xiaohua Sylvia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaohua Sylvia Chen

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Winnie Wing Sze Mak

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Department of Applied Social Sciences, PolyU

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Xiaohua Sylvia Chen

Role: CONTACT

Kai Lam Cheng

Role: CONTACT

Facility Contacts

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Xiaohua Sylvia Chen

Role: primary

References

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Topper, M., Emmelkamp, P. M., & Ehring, T. (2010). Improving prevention of depression and anxiety disorders: Repetitive negative thinking as a promising target. Applied and Preventive Psychology, 14, 57-71.

Reference Type BACKGROUND

Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.

Reference Type BACKGROUND
PMID: 32466251 (View on PubMed)

Freeman D, Haselton P, Freeman J, Spanlang B, Kishore S, Albery E, Denne M, Brown P, Slater M, Nickless A. Automated psychological therapy using immersive virtual reality for treatment of fear of heights: a single-blind, parallel-group, randomised controlled trial. Lancet Psychiatry. 2018 Aug;5(8):625-632. doi: 10.1016/S2215-0366(18)30226-8. Epub 2018 Jul 11.

Reference Type BACKGROUND
PMID: 30007519 (View on PubMed)

Riva G. Virtual reality in psychotherapy: review. Cyberpsychol Behav. 2005 Jun;8(3):220-30; discussion 231-40. doi: 10.1089/cpb.2005.8.220.

Reference Type BACKGROUND
PMID: 15971972 (View on PubMed)

Martingano, A. J., Hererra, F., & Konrath, S. (2021). Virtual reality improves emotional but not cognitive empathy: A meta-analysis. Technology, Mind, and Behavior. http://doi.org/10.1037/tmb0000034

Reference Type BACKGROUND

Van Kerrebroeck, H., Brengman, M., & Willems, K. (2017). When brands come to life: experimental research on the vividness effect of Virtual Reality in transformational marketing communications. Virtual Reality, 21(4), 177-191. http://doi.org/10.1007/s10055-017-0306-3

Reference Type BACKGROUND

Peters L, Sunderland M, Andrews G, Rapee RM, Mattick RP. Development of a short form Social Interaction Anxiety (SIAS) and Social Phobia Scale (SPS) using nonparametric item response theory: the SIAS-6 and the SPS-6. Psychol Assess. 2012 Mar;24(1):66-76. doi: 10.1037/a0024544. Epub 2011 Jul 11.

Reference Type RESULT
PMID: 21744971 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type RESULT
PMID: 11556941 (View on PubMed)

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

Reference Type RESULT
PMID: 16717171 (View on PubMed)

Keetharuth AD, Brazier J, Connell J, Bjorner JB, Carlton J, Taylor Buck E, Ricketts T, McKendrick K, Browne J, Croudace T, Barkham M. Recovering Quality of Life (ReQoL): a new generic self-reported outcome measure for use with people experiencing mental health difficulties. Br J Psychiatry. 2018 Jan;212(1):42-49. doi: 10.1192/bjp.2017.10.

Reference Type RESULT
PMID: 29433611 (View on PubMed)

Weeks JW, Heimberg RG, Fresco DM, Hart TA, Turk CL, Schneier FR, Liebowitz MR. Empirical validation and psychometric evaluation of the Brief Fear of Negative Evaluation Scale in patients with social anxiety disorder. Psychol Assess. 2005 Jun;17(2):179-90. doi: 10.1037/1040-3590.17.2.179.

Reference Type RESULT
PMID: 16029105 (View on PubMed)

Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

Reference Type RESULT
PMID: 11983645 (View on PubMed)

Freeman, D., & Lambe, L. (2019b). Self-Report: Oxford Behavioural Avoidance Task, version 2. University of Oxford.

Reference Type RESULT

Rosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and Commitment Therapy. Measures Package, 61.

Reference Type RESULT

Miragall M, Banos RM, Cebolla A, Botella C. Working alliance inventory applied to virtual and augmented reality (WAI-VAR): psychometrics and therapeutic outcomes. Front Psychol. 2015 Oct 8;6:1531. doi: 10.3389/fpsyg.2015.01531. eCollection 2015.

Reference Type RESULT
PMID: 26500589 (View on PubMed)

Laforest, M., Bouchard, S., Crétu, A., & Mesly, O. (2016). Inducing an Anxiety Response Using a Contaminated Virtual Environment: Validation of a Therapeutic Tool for Obsessive-Compulsive Disorder. Frontiers In ICT, 3. https://doi.org/10.3389/fict.2016.00018

Reference Type RESULT

Bailenson JN, Blascovich J, Beall AC, Loomis JM. Interpersonal distance in immersive virtual environments. Pers Soc Psychol Bull. 2003 Jul;29(7):819-33. doi: 10.1177/0146167203029007002.

Reference Type RESULT
PMID: 15018671 (View on PubMed)

Hayes SA, Miller NA, Hope DA, Heimberg RG, Juster HR. Assessing Client Progress Session by Session in the Treatment of Social Anxiety Disorder: The Social Anxiety Session Change Index. Cogn Behav Pract. 2008 May 1;15(2):203-2011. doi: 10.1016/j.cbpra.2007.02.010.

Reference Type RESULT
PMID: 25075171 (View on PubMed)

Other Identifiers

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HSEARS20240214005

Identifier Type: -

Identifier Source: org_study_id

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