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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH119225 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sadness Ratings Following Laboratory Stressor (Immediately Post-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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Woody, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36085716 | Derived | 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. |
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We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data repository/sharing.
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All enrolled participants were assigned to the neurofeedback arm; no participants were excluded prior to assignment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All 15 participants assigned to the neurofeedback arm were included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Sep 2025 | Mean | Standard Deviation | Proportion (0-1) | Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day. |
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Single-session monitoring on the intervention day: from the start of baseline procedures (pre-neurofeedback) through 60 minutes after completion of the neurofeedback session; total monitoring duration ≈ 2 hours on the same day.
Adverse events were monitored continuously during the above window via non-systematic assessment: spontaneous participant report and study-staff observation. Participants were queried at end-of-session and again at +60 minutes prior to discharge. No adverse events were observed or reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Woody, PhD Assistant Professor of Psychiatry | University of Pittsburgh | 4123832143 | mlw114@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2025 | Sep 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2021 | Sep 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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) | 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. | Baseline and following laboratory stressor (~30 minutes) |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| SSVEP competition index | Competition indices for attention to the primary task vs. negative emotional distractors were calculated as the proportion of t-transformed SSVEP amplitudes to the task stimulus relative to the sum of amplitudes to both task and distractor stimuli (Task / [Task + Distractor]). Scores range from 0-1, with values above .50 reflecting greater attention to the task stimulus. | Mean | Standard Deviation | Proportion (0-1) |
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| Visual Analog Score - Sadness | Participants rated their level of sadness on a Visual Analogue Scale (VAS) ranging from 0 = 'not at all' to 100 = 'extremely'. Scores reflect self-reported intensity of the emotional state at baseline. | One participant did not complete the baseline VAS Sadness measure, so data are reported for 14 participants. | Mean | Standard Deviation | Score on 0-100 scale |
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| Visual Analog Score - Anxiety | Participants rated their level of anxiety on a Visual Analogue Scale (VAS) ranging from 0 = 'not at all' to 100 = 'extremely'. Scores reflect self-reported intensity of the emotional state at baseline. | One participant did not complete the baseline VAS Anxiety measure, so data are reported for 14 participants. | Mean | Standard Deviation | Score on 0-100 scale |
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| Secondary | Sadness Ratings Following Laboratory Stressor (Immediately Post-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. | Three participants had missing VAS Sadness scores following the stressor. | Posted | Mean | Standard Deviation | Score on 0-100 scale | Approximately 30 minutes total: baseline sadness rating immediately before and post-stressor rating immediately after the ~30-minute laboratory stressor on the same day. |
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| Secondary | Anxiety Rating Following Laboratory Stressor (Immediately Post-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. | Three participants had missing VAS anxiety ratings following the stressor. | Posted | Mean | Standard Deviation | Score on 0-100 scale | Baseline and following laboratory stressor (~30 minutes) |
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| 0 |
| 15 |
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| 15 |
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| 15 |
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| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |