Trial Outcomes & Findings for Adolescent Attention to Emotion Study (NCT NCT04105868)
NCT ID: NCT04105868
Last Updated: 2025-11-13
Results Overview
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.
COMPLETED
NA
15 participants
Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day.
2025-11-13
Participant Flow
Female adolescents aged 13-15 were recruited from the community to participate in a single-arm neurofeedback study on affect-biased attention. A total of 15 participants were enrolled.
All enrolled participants were assigned to the neurofeedback arm; no participants were excluded prior to assignment.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not complete the baseline VAS Sadness measure, so data are reported for 14 participants.
Baseline characteristics by cohort
| Measure |
Neurofeedback
n=15 Participants
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.
|
|---|---|
|
Age, Continuous
|
14.67 Years
STANDARD_DEVIATION .90 • n=15 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
|
SSVEP competition index
|
.66 Proportion (0-1)
STANDARD_DEVIATION .17 • n=15 Participants
|
|
Visual Analog Score - Sadness
|
4.61 Score on 0-100 scale
STANDARD_DEVIATION 12.72 • n=14 Participants • One participant did not complete the baseline VAS Sadness measure, so data are reported for 14 participants.
|
|
Visual Analog Score - Anxiety
|
4.15 Score on 0-100 scale
STANDARD_DEVIATION 6.59 • n=14 Participants • One participant did not complete the baseline VAS Anxiety measure, so data are reported for 14 participants.
|
PRIMARY outcome
Timeframe: Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day.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.
Outcome measures
| Measure |
Neurofeedback
n=15 Participants
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.
|
|---|---|
|
Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention)
|
.41 Proportion (0-1)
Standard Deviation .18
|
SECONDARY outcome
Timeframe: Approximately 30 minutes total: baseline sadness rating immediately before and post-stressor rating immediately after the ~30-minute laboratory stressor on the same day.Population: Three participants had missing VAS Sadness scores following the stressor.
Participants completed a laboratory stressor following real-time SSVEP neurofeedback training to assess how well the intervention buffered sadness reactivity. State sadness was assessed immediately before and immediately after the stressor using a 100-millimeter visual analog scale (VAS) ranging from "neutral" to "very sad." Higher scores indicate greater sadness. The value reported below reflects the post-stressor rating.
Outcome measures
| Measure |
Neurofeedback
n=12 Participants
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.
|
|---|---|
|
Sadness Ratings Following Laboratory Stressor (Immediately Post-Stressor)
|
2.80 Score on 0-100 scale
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: Baseline and following laboratory stressor (~30 minutes)Population: Three participants had missing VAS anxiety ratings following the stressor.
Participants completed a laboratory stressor following real-time SSVEP neurofeedback training to assess how well the intervention buffered sadness reactivity. State anxiety was assessed immediately before and immediately after the stressor using a 100-millimeter visual analog scale (VAS) ranging from "neutral" to "very anxious." Higher scores indicate greater anxiety. The value reported below reflects the post-stressor rating.
Outcome measures
| Measure |
Neurofeedback
n=12 Participants
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.
|
|---|---|
|
Anxiety Rating Following Laboratory Stressor (Immediately Post-Stressor)
|
3.29 Score on 0-100 scale
Standard Deviation 4.58
|
Adverse Events
Neurofeedback
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary Woody, PhD Assistant Professor of Psychiatry
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place