Social AnxietyNCT02493010
Arousal Training for Social Anxiety Disorder
A study testing Arousal-based biofeedback system in people with Social Anxiety, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
The primary objective of the study is to examine the safety, usability and preliminary efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The investigators hypothesize that after 4 weeks of hour-long interventions, participants will show reductions pre- and post-intervention in their… Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Arousal-based biofeedback system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2016to Jul 2017
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate in English
- Computer literate
- Able to travel independently
- Agreeable to being video-recorded when going through study protocol
- Liebowitz Social Anxiety Scale score of 31 or more
- Public Speaking Anxiety Scale score of 60 or more
- Alcohol Use Disorders Identification Test (AUDIT) of 8 and below
Who cannot join
- Has gross visual or hearing impairments
- Has irregular heart rhythm
- On any psychoactive medication
- Involved in any other long-term research study
- Current or previous history of neuropsychiatric disorders (other than depression, which will be assessed by BDI-II)
- Suicide ideation
- Concurrent psychotherapy for any disorder
- Non-responding to a previous psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arousal Detection and Training for Social Anxiety Disorder (SAD)
The primary objective of the study is to examine the safety, usability and preliminary efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The investigators hypothesize that after 4 weeks of hour-long interventions, participants will show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.
Read the detailed description
The investigators plan to conduct a waitlist control trial.
Intervention consists of a combination of computerized cognitive behavioral therapy and arousal-based Virtual Reality Exposure Therapy. During the latter component, the physiological variables of participants, such as pulse rate and EEG, will be continuously monitored and presented as feedback to them. Participants will have to deliver speeches to videotaped audiences while striving to regulate their physiological arousal.
- Conditions
- Social Anxiety
- Being tested
- Arousal-based biofeedback system
- Keywords
- Virtual Reality Exposure Therapy, Computerized Cognitive Behavioral Therapy, Public Speaking, Social Phobia, Biofeedback
- Medical subject headings
- Speech, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arousal-based biofeedback systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will undergo a 4-week intervention (once per week, 1 hour each session). Each intervention session consists of approximately 30 minutes of computerized cognitive behavioral therapy, and 30 minutes of Virtual Reality Exposure Therapy with our novel arousal-based biofeedback system. For Virtual Reality Exposure Therapy, the physiological variables of participants will be continuously monitored and presented to them as feedback. Participants will have to deliver speeches to videotaped audiences while striving to regulate their physiological arousal. Receives: Device: Arousal-based biofeedback system |
| Waitlist Control | No intervention | Participants in Waitlist Control will receive no intervention in the first 4 weeks of the study. After the Intervention group has completed treatment, participants in the Waitlist Control will then undergo the same intervention as the Intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liebowitz Social Anxiety Scale scores from Week 0 to Week 5
A validated 24-item scale that is commonly used in social anxiety studies.
Measured: Week 0 (Pre-intervention) and Week 5 (Post-intervention)
Satisfaction and Immersion Questionnaire
A 22-item questionnaire that examines how effective, enjoyable and realistic the intervention is to participants.
Measured: Week 4 (post-intervention) for Intervention group and Week 9 (post-intervention) for Waitlist Control group
Safety Measure: After each intervention session (once a week), participants will be queried on whether they have experienced any physical or psychological adverse events during the study
The total number and severity rating of all adverse events reported will be collated at the end of the study.
Measured: Week 1 to Week 4 for Intervention and Week 6 to Week 9 for Waitlist Control
Secondary outcomes (3)
Change in Fear of Negative Evaluation-Brief (FNE-B) scores
According to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V), fear of negative evaluation is at the core of Social Anxiety Disorder. This 12-item self-report scale is a commonly used outcome measure in social anxiety studies.
Measured: Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Self-Statements during Public Speaking (SSPS) scores
A 10-item Likert-scale instrument measuring extent of negative and positive thoughts about oneself during public speaking.
Measured: Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5
A 17-item self-rating scale that measures public speaking anxiety.
Measured: Week 0 (pre-intervention) and Week 5 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research, Singapore General Hospital
- Responsible party
- Principal investigator, Lee Tih Shih, Duke-NUS Graduate Medical School
- Investigators
- Tih-Shih Lee, MD PHD, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493010
- Sponsor's protocol ID
- B-14-098
- Status last verified
- Dec 2017
- First submitted
- 24 Jul 2014
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin XB, Lee TS, Cheung YB, Ling J, Poon SH, Lim L, Zhang HH, Chin ZY, Wang CC, Krishnan R, Guan C. Exposure Therapy With Personalized Real-Time Arousal Detection and Feedback to Alleviate Social Anxiety Symptoms in an Analogue Adult Sample: Pilot Proof-of-Concept Randomized Controlled Trial. JMIR Ment Health. 2019 Jun 14;6(6):e13869. doi: 10.2196/13869.
PubMed 31199347
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arousal Detection and Training for Social Anxiety Disorder (SAD)
- ClinicalTrials.gov ID
- NCT02493010
- Acronym / sponsor ID
- B-14-098
- Conditions
- Social Anxiety
- Keywords
- Virtual Reality Exposure Therapy, Computerized Cognitive Behavioral Therapy, Public Speaking, Social Phobia, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research, Singapore General Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Jul 2015 (estimated)
- 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 primary objective of the study is to examine the safety, usability and preliminary efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The investigators hypothesize that after 4 weeks of hour-long interventions, participants will show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.
Detailed description
The investigators plan to conduct a waitlist control trial.
Intervention consists of a combination of computerized cognitive behavioral therapy and arousal-based Virtual Reality Exposure Therapy. During the latter component, the physiological variables of participants, such as pulse rate and EEG, will be continuously monitored and presented as feedback to them. Participants will have to deliver speeches to videotaped audiences while striving to regulate their physiological arousal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Arousal-based biofeedback systemParticipants will undergo a 4-week intervention (once per week, 1 hour each session). Each intervention session consists of approximately 30 minutes of computerized cognitive behavioral therapy, and 30 minutes of Virtual Reality Exposure Therapy with our novel arousal-based biofeedback system. For Virtual Reality Exposure Therapy, the physiological variables of participants will be continuously monitored and presented to them as feedback. Participants will have to deliver speeches to videotaped audiences while striving to regulate their physiological arousal. |
| Waitlist Control | No intervention | –Participants in Waitlist Control will receive no intervention in the first 4 weeks of the study. After the Intervention group has completed treatment, participants in the Waitlist Control will then undergo the same intervention as the Intervention group. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Literate in English
- Computer literate
- Able to travel independently
- Agreeable to being video-recorded when going through study protocol
- Liebowitz Social Anxiety Scale score of 31 or more
Key exclusion criteria (8 listed)
- Has gross visual or hearing impairments
- Has irregular heart rhythm
- On any psychoactive medication
- Involved in any other long-term research study
- Current or previous history of neuropsychiatric disorders (other than depression, which will be assessed by BDI-II)
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 |
|---|---|---|
| Arousal-based biofeedback system | Device | Intervention |
Primary outcome
Change in Liebowitz Social Anxiety Scale scores from Week 0 to Week 5
Time frame: Week 0 (Pre-intervention) and Week 5 (Post-intervention)
A validated 24-item scale that is commonly used in social anxiety studies.
Satisfaction and Immersion Questionnaire
Time frame: Week 4 (post-intervention) for Intervention group and Week 9 (post-intervention) for Waitlist Control group
A 22-item questionnaire that examines how effective, enjoyable and realistic the intervention is to participants.
Safety Measure: After each intervention session (once a week), participants will be queried on whether they have experienced any physical or psychological adverse events during the study
Time frame: Week 1 to Week 4 for Intervention and Week 6 to Week 9 for Waitlist Control
The total number and severity rating of all adverse events reported will be collated at the end of the study.
3 secondary outcomes
Change in Fear of Negative Evaluation-Brief (FNE-B) scores
Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Self-Statements during Public Speaking (SSPS) scores
Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5
Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Derived from this study: PubMed 31199347Lin XB, Lee TS, Cheung YB, Ling J, Poon SH, Lim L, Zhang HH, Chin ZY, Wang CC, Krishnan R, Guan C. Exposure Therapy With Personalized Real-Time Arousal Detection and Feedback to Alleviate Social Anxiety Symptoms in an Analogue Adult Sample: Pilot Proof-of-Concept Randomized Controlled Trial. JMIR Ment Health. 2019 Jun 14;6(6):e13869. doi: 10.2196/13869.
Related trials for Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
Social Anxiety Disorder, Social Fear
Active, not recruitingPhase 2
Pramipexole to Enhance Social Connections
Anxiety Disorders, Anxiety
Recruiting
CommunityRx-Dementia + Peer Navigation (CRxDpeer)
Alzheimer s Disease, Dementia
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.
Tih-Shih Lee, MD PHD principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arousal-based biofeedback system in people with Social Anxiety, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 2017. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liebowitz Social Anxiety Scale scores from Week 0 to Week 5 (time frame: Week 0 (Pre-intervention) and Week 5 (Post-intervention)). The study lists 3 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 NCT02493010, which also lists 1 linked publication.
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 19 Dec 2017; AzTrials last refreshed its copy on 2 Nov 2026.