Adolescent Attention to Emotion Study

NCT ID: NCT04105868

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2025-03-30

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Neurofeedback

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.

Group Type: EXPERIMENTAL

Neurofeedback

Intervention Type: OTHER

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.

Interventions

Neurofeedback

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Lifetime history of any Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 depressive disorder

2. Lifetime history of taking antidepressants [e.g., selective serotonin reuptake inhibitor (SSRIs)]

3. Lifetime history of a DSM 5 psychotic, bipolar, or autistic spectrum disorder.

4. Presence of EEG contraindications (e.g., personal lifetime history of seizures or family history of hereditary epilepsy).

5. Being pre-pubertal

6. Lifetime history of a neurological or serious medical condition.

7. Lifetime history of head injury or congenital neurological anomalies (based on parent report).

8. Intelligence quotient (IQ) less than 80, as assessed using the Wechsler Abbreviated Scale of Intelligence (WASI).

9. Uncorrected visual disturbance

10. Being acutely suicidal or at risk for harm to self or others.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Mary Woody

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Woody, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36085716 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH119225

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19010063

Identifier Type: -

Identifier Source: org_study_id