Social Avoidant BehaviorNCT06450665
Reducing Social Avoidance Among Adolescents With Special Educational Needs
A study testing VR Social Avoidance Intervention in people with Social Avoidant Behavior and Social Anxiety, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Avoidant Behavior, Social Anxiety
- What is being tested?
- VR Social Avoidance Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jun 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-19
- Can read traditional Chinese and understand Cantonese
- Self-report on experiencing social avoidance symptoms
Who cannot join
- History of photosensitive epilepsy
- Impairment of stereoscopic vision
- Balance problems
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Applied Social Sciences, PolyU
Hong Kong
Xiaohua Sylvia Chen, 34003696, sylvia.chen@polyu.edu.hk
About this study
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.
Read the detailed 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.
- Conditions
- Social Avoidant Behavior, Social Anxiety
- Being tested
- VR Social Avoidance Intervention
- Keywords
- Social Avoidant Behavior, Adolescents, Special Education Needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Social Avoidance InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Social Avoidance Intervention | Experimental | 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. Receives: Behavioral: VR Social Avoidance Intervention |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st week, 4th week, 8th week
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.
Measured: 1st week, 4th week, 8th week
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.
Measured: 1st week, 4th week, 8th week
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.
Measured: 1st week, 4th week, 8th week
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.
Measured: 1st week, 4th week, 8th week
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.
Measured: 1st week, 4th week, 8th week
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).
Measured: 1st week, 4th week, 8th week
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".
Measured: 1st week, 4th week, 8th week
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.
Measured: 1st week, 4th week, 8th week, and after each session of VR intervention
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.
Measured: After each session of VR intervention
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.
Measured: 4th week
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.
Measured: 4th week
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.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Social Avoidant BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, CHEN Xiaohua Sylvia, The Hong Kong Polytechnic University
- Investigators
- Xiaohua Sylvia Chen, Principal investigator, The Hong Kong Polytechnic UniversityWinnie Wing Sze Mak, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450665
- Sponsor's protocol ID
- HSEARS20240214005
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 32466251Freeman 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.
PubMed 30007519Riva G. Virtual reality in psychotherapy: review. Cyberpsychol Behav. 2005 Jun;8(3):220-30; discussion 231-40. doi: 10.1089/cpb.2005.8.220.
PubMed 15971972Martingano, 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
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
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.
PubMed 21744971Kroenke 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.
PubMed 11556941Spitzer 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.
PubMed 16717171Keetharuth 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.
PubMed 29433611Weeks 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.
PubMed 16029105Mundt 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.
PubMed 11983645Freeman, D., & Lambe, L. (2019b). Self-Report: Oxford Behavioural Avoidance Task, version 2. University of Oxford.
Rosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and Commitment Therapy. Measures Package, 61.
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.
PubMed 26500589
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Social Avoidance Among Adolescents With Special Educational Needs
- ClinicalTrials.gov ID
- NCT06450665
- Acronym / sponsor ID
- HSEARS20240214005
- Conditions
- Social Avoidant Behavior, Social Anxiety
- Keywords
- Social Avoidant Behavior, Adolescents, Special Education Needs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Social Avoidance Intervention | Experimental | Behavioral: VR Social Avoidance InterventionThe 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 16-19
- Can read traditional Chinese and understand Cantonese
- Self-report on experiencing social avoidance symptoms
Key exclusion criteria (3 listed)
- History of photosensitive epilepsy
- Impairment of stereoscopic vision
- Balance problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Social Avoidance InterventionThe 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. | Behavioural | VR Social Avoidance Intervention |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 1st week, 4th week, 8th week
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.
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 1st week, 4th week, 8th week
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.
Work and Social Adjustment Scale (WSAS)
Time frame: 1st week, 4th week, 8th week
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.
Brief Fear of Negative Evaluation Scale (bFNE)
Time frame: 1st week, 4th week, 8th week
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.
Oxford Behavioural Avoidance Task - HK (OBAT-HK)
Time frame: 1st week, 4th week, 8th week
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.
Social phobia (SPS-6)
Time frame: 1st week, 4th week, 8th week
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.
Mental health related Quality of Life (REQoL-20)
Time frame: 1st week, 4th week, 8th week
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).
Self-esteem (RSE)
Time frame: 1st week, 4th week, 8th week
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".
Social Interaction Anxiety Scale-6 (SIAS-6)
Time frame: 1st week, 4th week, 8th week, and after each session of VR intervention
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.
Social Anxiety Session Change Index (SASCI)
Time frame: After each session of VR intervention
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.
Working Alliance Inventory applied to VR and AR (WAI-VAR)
Time frame: 4th week
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.
Gatineau Presence Questionnaire (GPQ)
Time frame: 4th week
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.
Social presence (SPSQ)
Time frame: 4th week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- BackgroundTopper, 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.
- Background: PubMed 32466251Choi 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.
- Background: PubMed 30007519Freeman 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.
- Background: PubMed 15971972Riva G. Virtual reality in psychotherapy: review. Cyberpsychol Behav. 2005 Jun;8(3):220-30; discussion 231-40. doi: 10.1089/cpb.2005.8.220.
- BackgroundMartingano, 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
- BackgroundVan 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
- Results publication: PubMed 21744971Peters 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.
- Results publication: PubMed 11556941Kroenke 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.
- Results publication: PubMed 16717171Spitzer 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.
- Results publication: PubMed 29433611Keetharuth 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.
- Results publication: PubMed 16029105Weeks 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.
- Results publication: PubMed 11983645Mundt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohua Sylvia Chen principal investigator
The Hong Kong Polytechnic University
Winnie Wing Sze Mak principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Social Avoidance Intervention in people with Social Avoidant Behavior and Social Anxiety, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Sylvia Chen (34003696, sylvia.chen@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: 1st week, 4th week, 8th week). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450665, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.