DepressionNCT04105868
Adolescent Attention to Emotion Study
A study testing Neurofeedback in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants will include 90 female adolescents ages 13 years 0 months through 15 years 11 months at study entry.
Who cannot join
- Lifetime history of any Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 depressive disorder
- Lifetime history of taking antidepressants [e.g., selective serotonin reuptake inhibitor (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.
Show all 10Show fewer
- Lifetime history of head injury or congenital neurological anomalies (based on parent report).
- Intelligence quotient (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
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
- Being tested
- Neurofeedback
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and following laboratory stressor (~30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start16 Oct 2019
- Primary completion23 Sep 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mary Woody, University of Pittsburgh
- Investigators
- Mary Woody, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105868
- Sponsor's protocol ID
- STUDY19010063
- Other IDs
- K23MH119225
- Status last verified
- Oct 2025
- First submitted
- 24 Sep 2019
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data repository/sharing.
Publications
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.
PubMed 36085716
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
- ClinicalTrials.gov ID
- NCT04105868
- Acronym / sponsor ID
- STUDY19010063
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 13 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Other: NeurofeedbackParticipants 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. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants will include 90 female adolescents ages 13 years 0 months through 15 years 11 months at study entry.
Key exclusion criteria (10 listed)
- Lifetime history of any Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 depressive disorder
- Lifetime history of taking antidepressants [e.g., selective serotonin reuptake inhibitor (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackParticipants 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. | Other | Neurofeedback |
Primary outcome
Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention)
Time frame: 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.
2 secondary outcomes
Sadness Ratings Following Laboratory Stressor (Immediately Post-Stressor)
Time frame: 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)
Time frame: Baseline and following laboratory stressor (~30 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36085716Huang 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.
- Individual participant dataSharing planned: No. We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data repository/sharing.
Related trials for Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Woody, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Depression, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention) (time frame: Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.