Sleep and Emotional Memory in Peripubertal Anxiety

NCT03643848 | Completed Results

• 1 other identifier: 1R01MH116005-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)

  Emotional Mnemonic Similarity Task. Participants view pictures depicting negative or neutral objects/scenes. After a delay period (1 week) they are presented with a second set of pictures that are the same (targets), slightly different (lures), or completely different (foils) from the first series of pictures. They are told to indicate by button press if images they are currently viewing are "old" or "new". Responding to the lures as old ("false alarms") provides a signature of generalization for each participant. To correct for response biases (i.e., a tendency to label items as "old") a Lure Generalization Index (LGI) is calculated which reflects corrected memory generalization by subtracting false alarm rates to foils from false alarm rates to lures. Larger LGI values indicate greater generalization (i.e., greater tendency to misidentify similar items as previously seen, accounting for overall biases to identify any items as previously seen). Minimum value -1 and maximum value =1

  Delayed recall, 1 week

Secondary Outcomes (1)

• Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)

  Recall, 12 hours

Study Arms (2)

Sleep with Sound Cues

EXPERIMENTAL

Sounds played at time of memory encoding will be replayed during sleep to cue memory processing.

Behavioral: Sleep with Sound Cues

Sleep with Sham Cues

SHAM COMPARATOR

Sounds that were not played at time of memory encoding will be played during sleep as a sham comparison

Behavioral: Sleep with Sham Cues

Interventions

Sleep with Sound Cues BEHAVIORAL

Experimental manipulation to observe effects on memory for learned material.

Sleep with Sound Cues

Sleep with Sham Cues BEHAVIORAL

Sham manipulation

Sleep with Sham Cues

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• For youth to be excluded from participation, they must:
• (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.
• (K) self-reported average sleep duration \< 6 hours or \> 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).

Sponsors & Collaborators

• Florida International University: lead

Study Sites (2)

Center for Children and Families, Florida International University

Miami, Florida, 33199, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Pilot study--small sample size, should be interpreted with caution until replication

Results Point of Contact

• Title: Dana L. McMakin, PhD, ABPP
• Organization: Florida International University

dmcmakin@fiu.edu

305-348-0042

Study Officials

• Dana McMakin, PhD

  Florida International University and Nicklaus Children's Hospital

  PRINCIPAL INVESTIGATOR

• Aaron Mattfeld, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind (participant, outcome assessor) for Aim 3 (sham versus target sounds)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Per NIMH policy at the time of funding, the current trial is considered a clinical trial due to prospective, randomized assignment to an "intervention" to observe effects on behavioral or health related outcomes. The "intervention" for Aim 3 (n=60) includes randomized assignment to sham sounds (sounds unrelated to the memory task) or target sounds (sounds that were played during the time of the memory task) that are played during sleep to cue memory processing.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 23, 2018
• Study Start: June 1, 2018
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: supporting docs available as part of original NIH grant. We will share individual data via NIH NDA per NIH policy timelines and guidance.

Locations

US (2)