Reducing Social Avoidance Among Adolescents With Special Educational Needs

Social Anxiety Clinical Trial

Official title:

Reducing Social Avoidance Among Adolescents With Special Educational Needs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450665
• Other study ID #: HSEARS20240214005
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: The Hong Kong Polytechnic University
• Contact: Xiaohua Sylvia Chen
• Phone: 34003696
• Email: sylvia.chen[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 208
• Est. completion date: May 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Social Anxiety

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Hong Kong	Department of Applied Social Sciences, PolyU	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (18)

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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. — View Citation

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. — View Citation

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

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 — View Citation

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 h — View Citation

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. — View Citation

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.2016.00

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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.

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

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)	To assess the extent to which respondents are bothered by depression related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with higher score indicating higher level of depressive symptoms.	1st week, 4th week, 8th week
Primary	Generalized Anxiety Disorder Assessment (GAD-7)	To assess the extent to which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with higher score indicating higher level of anxiety symptoms.	1st week, 4th week, 8th week
Primary	Work and Social Adjustment Scale (WSAS)	An adapted version of the 5-item WSAS will be used to measure the extent to which respondents' psychological problem impact their various aspects of life. It is rated on an 8-point Likert scale ranges from 0 (not at all impaired) to 8 (severely impaired). Higher score indicates higher level of impact on various aspects of life caused by psychological problems.	1st week, 4th week, 8th week
Primary	Brief Fear of Negative Evaluation Scale (bFNE)	This is a 12-item scale that measures the fear associated with being evaluated unfavorably while anticipating or participating in a social situation, including apprehension about receiving negative evaluation, avoidance of being evaluated, and the expectation of being negatively evaluated with a 5-point Likert-type rating scale, ranging from 1 (not at all characteristic of me) to 5 (extremely characteristic of me). Higher score indicates higher level of fear of Negative Evaluation.	1st week, 4th week, 8th week
Primary	Oxford Behavioural Avoidance Task - HK (OBAT-HK)	This is a 16-item scale, a local adaptation of Freeman's OBAT to assess the extent of which participants feel anxious in everyday situations, and the extent to which they try to avoid those situations. Examples of the situations are: approach another pedestrian to ask for direction, ask the bus driver about which stop you should get off, etc. Participants first answer a question concerning if they could do a specific task right now and then rate the level of distress if they have to perform the task straightaway from 0 (no distress) to 10 (extremely distress), with higher score indicating higher level of social anxiety.	1st week, 4th week, 8th week
Primary	Social phobia (SPS-6)	This 6-item scale (Peters et al., 2012), which is a shortened version of the 20-item SPS (Mattick & Clarke, 1998), measures individuals' self-report anxiety associated with the performance of various tasks while being scrutinized by others (e.g., working, eating, drinking, writing, using public toilets). It runs on a 5-point Likert scale from 0 (not at all characteristics or true of me) to 4 (extremely characteristics or true of me), with higher score indicating higher tendency of social phobia.	1st week, 4th week, 8th week
Primary	Mental health related Quality of Life (REQoL-20)	The 20-item scale measures quality of life with positively and negatively worded items in seven themes: activity, hope, belonging and relationships, self-perception, well-being, autonomy, and physical health. The item responses were captured on a five-point Likert scale ranging from 0 (none of the time) to 4 (most or all of the time).	1st week, 4th week, 8th week
Primary	Self-esteem (RSE)	Rosenberg's Self-Esteem Scale is the standard measure of self-esteem in psychological research. It is composed of 10 items, 5 of which are negatively worded. Scale point ranges from 1="strongly agree" to 4="strongly disagree".	1st week, 4th week, 8th week
Primary	Social Interaction Anxiety Scale-6 (SIAS-6)	This 6-item scale (Peters et al., 2012), which is a shortened version of the 20-item SIAS (Mattick, & Clarke, 1998), measures individuals' self-report distress when interacting with others. It runs on a 5-point Likert scale from 0 (not at all characteristics or true of me) to 4 (extremely characteristics or true of me), with higher score indicating higher tendency of social interaction anxiety.	1st week, 4th week, 8th week, and after each session of VR intervention
Primary	Social Anxiety Session Change Index (SASCI)	An adapted version of the 4-item SASCI will be used to track the intermediate changes for the VR sessions (i.e., a per session update of improvement/ deterioration of level of social avoidance) on four dimensions: anxiety, avoidance, concern about humiliation and embarrassment, and interference, using a 7-point Likert-type scale ranging from 1 (much less than the start of treatment) to 4 (not different from the start of treatment) to 7 (much more than the start of treatment), with lower score indicating less anxiety after the treatment.	After each session of VR intervention
Primary	Working Alliance Inventory applied to VR and AR (WAI-VAR)	This is a 12-item scale designed to assess therapeutic alliance between the virtual/augmented reality program and the users. Scale points range from 1 (never) to 7 (always), with higher score indicating higher level of adaptation to the VR environment.	4th week
Primary	Gatineau Presence Questionnaire (GPQ)	This is a 4-item scale (Laforest et al., 2016) designed to assess the feeling of presence experienced in a virtual environment. Sample items include "the impression of being here", "appraising the experience as being real". Scale point ranges from 0 to 100, with higher score indicating more feeling of presence experienced in a virtual environment.	4th week
Primary	Social presence (SPSQ)	The five-item social presence questionnaire measures how much participants perceived the virtual human in the room to be like an actual person. Participants rated on a Likert-type scale (from -3 to +3). A positive social presence score indicates that the participant perceived the virtual human as conscious and aware, whereas a negative score indicates that the participant perceived the virtual human as unconscious and unaware.	4th week