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Computerized Psycho-social Intervention for Anxiety Disorders
N/A
Recruiting
Led By Norman B Schmidt, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to measure brain responses in children with anxiety disorders to a psychosocial intervention, to see if it can reduce their reactivity to making mistakes & reduce anxiety.
Who is the study for?
This trial is for English-speaking children aged 9-12 with an anxiety disorder such as generalized anxiety, social anxiety, or OCD. They must be able to stand unassisted for 15 minutes. Children with severe psychopathology, recent head injuries, significant medical conditions or disabilities that affect standing are excluded.
What is being tested?
The study tests a computerized intervention designed to reduce error sensitivity in anxious children by measuring changes in brain activity related to errors (ERN) and balance disturbances (balance N1). Half of the participants will receive this intervention while the other half will get a control computerized presentation on healthy lifestyle choices.
What are the potential side effects?
Since this is a psycho-social and computer-based intervention without medication involved, traditional side effects are not expected. However, there may be temporary increases in anxiety or discomfort during participation due to focusing on error sensitivity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in ERN after intervention
Change in balance N1 after intervention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Control ConditionActive Control1 Intervention
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Who is running the clinical trial?
Florida State UniversityLead Sponsor
224 Previous Clinical Trials
36,561 Total Patients Enrolled
16 Trials studying Anxiety Disorders
2,671 Patients Enrolled for Anxiety Disorders
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,741,933 Total Patients Enrolled
165 Trials studying Anxiety Disorders
69,086 Patients Enrolled for Anxiety Disorders
Norman B Schmidt, PhDPrincipal InvestigatorFlorida State University
3 Previous Clinical Trials
271 Total Patients Enrolled
Greg Hajcak, PhDPrincipal InvestigatorFlorida State University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with depression or ADHD.I do not have an English-speaking primary caregiver to accompany my child to lab visits.My child speaks English.I can stand for 15 minutes without help.I have a condition or disability that prevents me from standing.I have been diagnosed with an anxiety disorder.I've had a head injury that made me lose consciousness in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Control Condition
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.