A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT00104195

Collaborator

(none)

127

Enrollment

Location

122

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to study how teens with and without an anxiety disorder make decisions.

This is a brain imaging study using functional magnetic resonance imaging (fMRI) in adolescents between the ages of 13 and 17.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Separation Anxiety Disorder Phobic Disorders

Detailed Description

Preliminary analyses of behavioral data showed no group differences in response times during the decision-making games. However, behavioral ratings of certainty during the task showed differences between groups. Anxiety-disordered participants indicated lower levels of certainty during the most uncertain conditions of the task (p < .05). This difference was consistent with the study hypothesis. Within-subjects analyses of the decision-making tasks showed that subjects responded as expected. Reaction times (RT) during uncertain conditions of the HiLo-Game were significantly longer than during more certain conditions (p = .001). Diary Task RTs for rating ambiguous situations were significantly longer than ratings of unambiguous situations (p = .019). Preliminary Analyses showed a significant correlation between Intolerance of Uncertainty (IU) and RT during the Marble Task (r = -0.54, p < .05). Preliminary analysis also showed significant correlation between ratings of level of anxiety during the diary task and IU, IS, MASC and the child version of the SCARED. These preliminary results were not submitted for publication.

Study Design

Study Type:

Observational

Actual Enrollment :

127 participants

Observational Model:

Case-Control

Official Title:

Decision-Making Processes and Brain Function in Anxiety-Disordered and Non-Anxious Youth

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Outcome Measures

Primary Outcome Measures

Intolerance of Uncertainty [at time of assessment/enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Must meet diagnostic criteria for Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia, OR must be free of medical, psychiatric, neurologic conditions and learning disorders (healthy controls)
Sufficient intelligence to understand the study and provide truly informed consent; will be determined by educational history

Exclusion Criteria:

Having any major medical conditions that may interfere with interpretation of results or be associated with risk in an MRI environment (history of metal implants, or contraindications to MRI scanning for research purposes, including pregnancy)
Current evidence of Autism, Major Depression, Substance Abuse, Obsessive Compulsive Disorder, Post-traumatic Stress Disorder, Panic Disorder, Tic Disorders, significant suicidality, lifetime history of psychosis or mania.
Estimated Full-Scale IQ below 80
Inability or unwillingness to remain still during scanning
Inability or unwillingness to provide assent
Absence of signed consent by parent or legal guardian
Current history of sexual or physical abuse in the family, or past sexual or physical abuse if there is ongoing Department of Social Services (DSS) involvement