Depression
Conditions
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.
Interventions
OTHERNeurofeedback
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.
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 15 Years
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 Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 depressive disorder 2. Lifetime history of taking antidepressants \[e.g., selective serotonin reuptake inhibitor (SSRIs)\] 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. Intelligence quotient (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sadness Ratings Following Laboratory Stressor (Immediately Post-Stressor) | Approximately 30 minutes total: baseline sadness rating immediately before and post-stressor rating immediately after the ~30-minute laboratory stressor on the same day. | 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. |
| Anxiety Rating Following Laboratory Stressor (Immediately Post-Stressor) | Baseline and following laboratory stressor (~30 minutes) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All enrolled participants were assigned to the neurofeedback arm; no participants were excluded prior to assignment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Neurofeedback |
|---|---|
| Age, Continuous | 14.67 Years STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
| SSVEP competition index | .66 Proportion (0-1) STANDARD_DEVIATION 0.17 |
| Visual Analog Score - Anxiety | 4.15 Score on 0-100 scale STANDARD_DEVIATION 6.59 |
| Visual Analog Score - Sadness | 4.61 Score on 0-100 scale STANDARD_DEVIATION 12.72 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurofeedback | Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention) | .41 Proportion (0-1) | Standard Deviation 0.18 |
Comparison: Null hypothesis: No within-subject change in SSVEP competition index from baseline to post-training.p-value: 0.004t-test, 2 sided
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.
Time frame: Baseline and following laboratory stressor (~30 minutes)
Population: Three participants had missing VAS anxiety ratings following the stressor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurofeedback | Anxiety Rating Following Laboratory Stressor (Immediately Post-Stressor) | 3.29 Score on 0-100 scale | Standard Deviation 4.58 |
Comparison: Null hypothesis: No within-subject change in VAS Anxiety scores from baseline to post-stressor.p-value: 0.471t-test, 2 sided
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.
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.
Population: Three participants had missing VAS Sadness scores following the stressor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurofeedback | Sadness Ratings Following Laboratory Stressor (Immediately Post-Stressor) | 2.80 Score on 0-100 scale | Standard Deviation 5.85 |
Comparison: Null hypothesis: No within-subject change in VAS Sadness scores from baseline to post-stressor.p-value: 0.25t-test, 2 sided