NCT04105868

Brief Summary

Rates of depression increase rapidly during adolescence, especially for girls, and, thus, research is needed to spur the development of novel interventions to prevent adolescent depression. This project seeks to determine if a novel visuocortical probe of affect-biased attention (i.e., steady-state visual evoked potentials derived from EEG) can 1) be used to prospectively predict depression using a multi-wave repeated measures design and 2) modify affect-biased attention and buffer subsequent mood reactivity using real time neurofeedback. This work could ultimately lead to improved identification of adolescents who are at high risk for depression and directly inform the development of mechanistic treatment targets to be used in personalized intervention prescriptions for high-risk youth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 13, 2025

Completed
Last Updated

November 13, 2025

Status Verified

October 1, 2025

Enrollment Period

4.9 years

First QC Date

September 24, 2019

Results QC Date

September 24, 2025

Last Update Submit

October 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention)

    To measure affect-biased attention, steady-state visual evoked potentials (SSVEPs) were derived from EEG and used to index the amount of stimulus-driven attention to negative distractors relative to task-relevant stimuli. Affect-biased attention was assessed immediately before and immediately after the real-time SSVEP neurofeedback training to evaluate changes within the same session. The outcome below reflects the post-neurofeedback SSVEP competition index (Task / \[Task + Distractor\]). Scores above .50 indicate greater attention to the task stimulus.

    Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day.

Secondary Outcomes (2)

  • Sadness Ratings Following Laboratory Stressor (Immediately Post-Stressor)

    Approximately 30 minutes total: baseline sadness rating immediately before and post-stressor rating immediately after the ~30-minute laboratory stressor on the same day.

  • Anxiety Rating Following Laboratory Stressor (Immediately Post-Stressor)

    Baseline and following laboratory stressor (~30 minutes)

Study Arms (1)

Neurofeedback

EXPERIMENTAL

Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.

Other: Neurofeedback

Interventions

Participants will receive feedback during a computerized task that is based on their own visuocortical activity evoked by attention to negative distractors and task-relevant stimuli on the computer screen.

Neurofeedback

Eligibility Criteria

Age13 Years - 15 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants will include 90 female adolescents ages 13 years 0 months through 15 years 11 months at study entry.

You may not qualify if:

  • Lifetime history of any Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 depressive disorder
  • Lifetime history of taking antidepressants \[e.g., selective serotonin reuptake inhibitor (SSRIs)\]
  • Lifetime history of a DSM 5 psychotic, bipolar, or autistic spectrum disorder.
  • Presence of EEG contraindications (e.g., personal lifetime history of seizures or family history of hereditary epilepsy).
  • Being pre-pubertal
  • Lifetime history of a neurological or serious medical condition.
  • Lifetime history of head injury or congenital neurological anomalies (based on parent report).
  • Intelligence quotient (IQ) less than 80, as assessed using the Wechsler Abbreviated Scale of Intelligence (WASI).
  • Uncorrected visual disturbance
  • Being acutely suicidal or at risk for harm to self or others.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Huang X, Mak J, Wears A, Price RB, Akcakaya M, Ostadabbas S, Woody ML. Using Neurofeedback from Steady-State Visual Evoked Potentials to Target Affect-Biased Attention in Augmented Reality. Annu Int Conf IEEE Eng Med Biol Soc. 2022 Jul;2022:2314-2318. doi: 10.1109/EMBC48229.2022.9871982.

MeSH Terms

Conditions

Depression

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Limitations and Caveats

The study was a small, single-arm pilot trial with 15 participants, which may limit generalizability. Results should be interpreted as preliminary pending replication in larger, controlled samples.

Results Point of Contact

Title
Mary Woody, PhD Assistant Professor of Psychiatry
Organization
University of Pittsburgh

Study Officials

  • Mary Woody, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

October 16, 2019

Primary Completion

September 23, 2024

Study Completion

March 30, 2025

Last Updated

November 13, 2025

Results First Posted

November 13, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data repository/sharing.

Locations