Intervention for Phobia, Social

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Phobia, Social+6 More
Psycho-social, computerized intervention targeting error sensitivity - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

Anxiety disorders are the most common form of psychopathology, and frequently begin in childhood, resulting in lifelong impairment. Increased brain activity after making mistakes, as reflected by the error-related negativity (ERN), is observed in people with anxiety disorders, even before disorder onset. The ERN is therefore of great interest as a potentially modifiable risk factor for anxiety. However, methodological issues can make the ERN difficult to measure. Increased brain activity in response to a balance disturbance, as reflected by the balance N1, resembles the ERN, but does not share its methodological issues. The investigators' preliminary data demonstrate that the balance N1 and the ERN are associated in amplitude in adults, suggesting they may depend on the same brain processes. The balance N1 has never been investigated in individuals with anxiety disorders, but it increases in amplitude within individuals under anxiety-inducing environmental contexts. Further, balance and anxiety are related in terms of brain anatomy, daily behavior, disorder presentation, and response to treatment. The present investigation will measure the ERN and the balance N1 in children (ages 9-12) with anxiety disorders, and further, how these brain activity measures change in response to a brief, 45-minute, computerized psychosocial intervention that was developed to reduce reactivity to errors, and has been shown to reduce the ERN. The investigators will recruit approximately 80 children with anxiety disorders, half of whom will be randomly assigned to the active intervention condition. The other half will be assigned to an active control condition, consisting of a different 45-minute computerized presentation. Participants assigned to the control condition can access the computerized intervention after participation in the study. The purpose of this investigation is to test the hypothesis that the balance N1 and the ERN will be reduced to a similar extent after the intervention, to demonstrate that these brain responses arise from shared brain processes. Transfer of the effect of the psycho-social intervention to the balance N1 would provide insight into prior work demonstrating that balance training can alleviate anxiety in young children, and well-documented benefits of psychotherapy to balance disorders. Collectively, these data may guide the development of multidisciplinary interventions for the prevention and treatment of anxiety disorders in children.

Eligible Conditions
  • Phobia, Social
  • Anxiety Disorders
  • Obsessive-Compulsive Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 1 hour

1 hour
Change in ERN after intervention
Change in balance N1 after intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Condition
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: Psycho-social, computerized intervention targeting error sensitivity · Intervention Types: Behavioral
Control Condition
Behavioral
ActiveComparator Group · 1 Intervention: Psycho-social, computerized intervention on healthy lifestyle choices · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 hour

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,522 Previous Clinical Trials
1,814,510 Total Patients Enrolled
29 Trials studying Phobia, Social
5,816 Patients Enrolled for Phobia, Social
Florida State UniversityLead Sponsor
157 Previous Clinical Trials
27,304 Total Patients Enrolled
5 Trials studying Phobia, Social
502 Patients Enrolled for Phobia, Social
Greg Hajcak, PhDPrincipal InvestigatorFlorida State University

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are an English-speaking child.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.