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N/A N=58 Randomized Double-blind Basic Science

Sleep and Emotional Memory in Peripubertal Anxiety

Anxiety

Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Scores on the Lure Generalization Index (a Behavioral Measure of Generalization) — .24; .26; .14; .10 units on a scale — p=<.046

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Sleep with Sound Cues (Behavioral); Sleep with Sham Cues (Behavioral)
Age
Pediatric · 10+ yrs
Sex
All
Sponsor
Florida International University
Primary completion
Mar 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)
.40; .40; .26; .30 =.61
SECONDARY
Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)
.40; .40; .26; .30 =.61

Summary

The current study aims to deepen understanding of the symptom dimension of negative overgeneralization in anxiety. Specifically, the study examines the malleability of memory processes that are known to occur during sleep that may underlie negative overgeneralization.

Eligibility Criteria

Inclusion Criteria

  • 10-13 years old
  • Able to understand and communicate in English and have a parent who is able to understand and communicate in English or Spanish
  • included across any range of symptoms of anxiety, and may meet full diagnostic criteria for Social Phobia, Generalized Anxiety and Separation Anxiety.
  • be right-handed.

Exclusion Criteria

  • For youth to be excluded from participation, they must:

(A) meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders (including autism spectrum disorders), Obsessive Compulsive Disorder, Attention-Deficit Hyperactivity Disorder, Conduct Disorder, Oppositional Defiant Disorder, Posttraumatic Stress Disorder, Bipolar Disorder, Tic disorder, Impulse Control Disorder, or Intellectual Disability. However, to improve generalizability, if Attention-Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Obsessive Compulsive Disorder, Mood Disorders (including past or present episodes of Major Depressive Disorder and/or dysthymia) or Posttraumatic stress Disorder co-occurs with an anxiety disorder (see Inclusion Criteria above) participants may be included.

(B) Children complete the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). Scores below 80 (i.e., two standard deviations below normed mean) are considered exclusionary for this study.

(C) show high likelihood and/or serious intent of hurting themselves or others.

(D) have not been living with a primary caregiver for at least 6 months who is legally able to give consent for the child's participation.

(E) be a victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families;

(F) have a serious vision problem that is not corrected with prescription lenses, or have prescription glasses outside of the range of -5.00 to +3.00 (contact lenses are ok).

(G) have a physical disability that interferes with their ability to lie in scanner and/or click a mouse button rapidly;

(H) have a serious hearing problem;

(I) have a history of neurological or other major medical conditions affecting brain function.

(J) current or past history of sleep disorder, as assessed during the screening; exclusionary sleep disorders will include sleep apnea, and circadian rhythm disturbances (i.e., advanced or delayed sleep-phase)

(K) self-reported average sleep duration 11 hours across weekday and weekend nights, or normal bedtime later than 1:00 am; .

(L) Are not suitable to undergo MRI scanning due to claustrophobia, certain implanted devices/metal (e.g., cardiac pacemaker, neurostimulator, some artificial joints, metal pins, surgical/aneurysm clips, heart valves, cochlear implants, retinal implants, shrapnel in eye, non-removable body piercing or other non-MRI compatible metal/device.

(M) Are pregnant.

(N) Some Color Tattoos.

(O) Color Contacts.

(P) Currently sick or recovering from illness.

(Q) Currently taking non-stimulant psychotropic medications. However, participants who have been off non- stimulant medication for at least 2 weeks (the typical washout period) may be included. Participants currently taking stimulant medications may be included, as long as medication was not taken within 24 hours of scans (at the discretion of the parent/legal guardian and prescribing physician).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03643848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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