search
Back to results

Adolescent Attention to Emotion Study

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

13 Years - 15 Years (Child)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Western Psychiatric Institute and ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurofeedback

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline in affect-biased attention subsequently 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

Change from baseline in sadness after laboratory stressor, which follows neurofeedback
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.
Change from baseline in anxiety after laboratory stressor, which follows neurofeedback
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.

Full Information

First Posted
September 24, 2019
Last Updated
October 27, 2022
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04105868
Brief Title
Adolescent Attention to Emotion Study
Official Title
Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in affect-biased attention subsequently following neurofeedback (~1 hour)
Description
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.
Time Frame
Baseline and following neurofeedback (~1 hour)
Secondary Outcome Measure Information:
Title
Change from baseline in sadness after laboratory stressor, which follows neurofeedback
Description
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.
Time Frame
Baseline and following laboratory stressor (~30 minutes)
Title
Change from baseline in anxiety after laboratory stressor, which follows neurofeedback
Description
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.
Time Frame
Baseline and following laboratory stressor (~30 minutes)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Lifetime history of any DSM 5 depressive disorder Lifetime history of taking antidepressants (e.g., 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Woody, PhD
Phone
412-383-2143
Email
woodyml@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nastasia McDonald, BS
Phone
412-383-5044
Email
mcdonaldno@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Woody, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Woody, Phd
Phone
412-648-6560

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will comply with all NIMH guidelines regarding data repository/sharing.
Citations:
PubMed Identifier
36085716
Citation
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.
Results Reference
derived

Learn more about this trial

Adolescent Attention to Emotion Study

We'll reach out to this number within 24 hrs