Adolescent Attention to Emotion Study

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT04105868
Collaborator
National Institute of Mental Health (NIMH) (NIH)
70
1
1
52.5
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Neurofeedback
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
Actual Study Start Date :
Oct 16, 2019
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in affect-biased attention subsequently following neurofeedback (~1 hour) [Baseline and following neurofeedback (~1 hour)]

    To measure affect-biased attention, steady-state visual evoked potentials (SSVEPs) will be derived from EEG and will be used to index the amount of stimulus-driven attention to the negative distractors relative to goal-directed attention toward task-relevant stimuli. Larger SSVEPs indicate more attention to that stimulus. Affect-biased attention will be measured both before and after the real time SSVEP neurofeedback training to assess changes in affect-biased attention pre- to post-intervention.

Secondary Outcome Measures

  1. Change from baseline in sadness after laboratory stressor, which follows neurofeedback [Baseline and following laboratory stressor (~30 minutes)]

    Participants will complete a laboratory stressor following real time SSVEP neurofeedback training to assess how well it buffers sadness reactivity. To assess sadness reactivity, girls will report state sadness before and after the stressor using Visual Analog Scales. Participants will mark how they are feeling between neutral to very sad on a scale measuring 100 millimeters, with higher scores indicating greater state sadness.

  2. Change from baseline in anxiety after laboratory stressor, which follows neurofeedback [Baseline and following laboratory stressor (~30 minutes)]

    Participants will complete a laboratory stressor following real time SSVEP neurofeedback training to assess how well it buffers anxiety reactivity. To assess anxiety reactivity, girls will report state anxiety before and after the stressor using Visual Analog Scales.Participants will mark how they are feeling between neutral to very anxious on a scale measuring 100 millimeters, with higher scores indicating greater state anxiety.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 15 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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 DSM 5 depressive disorder

  2. Lifetime history of taking antidepressants (e.g., 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. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western Psychiatric Institute and Clinic Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Mary Woody, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mary Woody, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04105868
Other Study ID Numbers:
  • STUDY19010063
  • K23MH119225
First Posted:
Sep 26, 2019
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2021