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Completed

NCT Number: NCT02493010

Arousal Training for Social Anxiety Disorder

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.

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Key information

Conditions

Social Anxiety Anxiety Disorders Behavior Communication Mental Disorders Phobia, Social Phobic Disorders Speech Verbal Behavior

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke-NUS Graduate Medical School

Singapore, 169857

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Arousal-based biofeedback system

Device

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Fear of Negative Evaluation-Brief (FNE-B) scores

    Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)

    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.

  2. Change in Self-Statements during Public Speaking (SSPS) scores

    Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)

    A 10-item Likert-scale instrument measuring extent of negative and positive thoughts about oneself during public speaking.

  3. Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5

    Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)

    A 17-item self-rating scale that measures public speaking anxiety.

Sponsors and collaborators

Lead sponsor

Duke-NUS Graduate Medical School

Other

Collaborators

  • Agency for Science, Technology and Research
  • Singapore General Hospital

Registry information

Official study title

Arousal Detection and Training for Social Anxiety Disorder (SAD)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 9, 2015
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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