Neurofeedback for Adolescent Depression

Overseen By Nastasia McDonald, BS

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Antidepressants

Disqualifiers: Depressive disorder, Psychotic, Bipolar, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have ever taken antidepressants.

Is neurofeedback safe for adolescents?

While the safety of neurofeedback has not been thoroughly investigated, clinical experience suggests it is reasonably safe for both youth and adults. ^{1 2 3 4 5}

How is neurofeedback treatment different from other treatments for adolescent depression?

Neurofeedback is unique because it is a non-drug treatment that uses real-time feedback from brain activity to help patients learn to regulate their brain function. Unlike medications, it does not involve taking any substances and instead focuses on self-regulation and neurophysiological changes. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Neurofeedback for Adolescent Depression?

Research suggests that neurofeedback, which involves training the brain to change its activity, may help reduce symptoms of depression in adolescents by improving emotional regulation and self-processing. Studies have shown that neurofeedback can lead to short-term changes in brain activity associated with reduced depression symptoms. ^{1 3 9 10 11}

Who Is on the Research Team?

Mary Woody, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for female adolescents aged 13 to nearly 16 who may be at risk for depression. They must have normal intelligence, no history of neurological issues or serious medical conditions, and cannot have taken antidepressants or have a history of certain mental health disorders.

Inclusion Criteria

I am a girl aged 13 to 15 years old.

Exclusion Criteria

I have not started puberty.

Presence of EEG contraindications (e.g., personal lifetime history of seizures or family history of hereditary epilepsy).

You have ever been diagnosed with a depressive disorder according to the DSM 5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Training

Participants receive real-time neurofeedback to modify affect-biased attention using EEG-derived steady-state visual evoked potentials

1 hour

1 visit (in-person)

Laboratory Stressor

Participants complete a laboratory stressor to assess changes in sadness and anxiety reactivity following neurofeedback

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in affect-biased attention and mood reactivity after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback

Trial Overview The study tests if a new method using EEG can predict depression in teens and if neurofeedback can change how they pay attention to emotions, possibly preventing mood problems later on.

How Is the Trial Designed?

Group I: Neurofeedback Experimental Treatment 1 Intervention

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.

Neurofeedback is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurofeedback for:

• Chronic low back pain
• Fibromyalgia
• Neuropathic pain

Approved in European Union as Neurofeedback for:

• Chronic pain
• Fibromyalgia
• Neuropathic pain

Approved in Canada as Neurofeedback for:

• Chronic pain
• Fibromyalgia

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Neurofeedback, including techniques like surface neurofeedback and advanced methods such as real-time z-score neurofeedback, shows promise in treating conditions like anxiety, mood disorders, and traumatic brain injury, particularly in children and adolescents.

The article emphasizes the need for more randomized controlled studies to establish effective clinical guidelines and to identify which patients may benefit most from neurofeedback interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG and neurofeedback in children and adolescents: anxiety disorders, depressive disorders, comorbid addiction and attention-deficit/hyperactivity disorder, and brain injury. Simkin, DR., Thatcher, RW., Lubar, J.[2015]

Neurofeedback (NF) has been explored as a treatment for various child psychiatric disorders, including ADHD, autism, learning disorders, and epilepsy, by providing real-time feedback on brain activity.

However, many studies on NF have methodological limitations, such as not using proper blinding or sham controls, and while clinical experience suggests NF is reasonably safe, its safety has not been rigorously studied in youth or adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. Hurt, E., Arnold, LE., Lofthouse, N.[2019]

Neurofeedback has shown clinical efficacy in treating children with ADHD, outperforming computerized attention training in a randomized controlled trial with a medium effect size.

The benefits of neurofeedback training appear to be stable for at least six months, with different training protocols (theta/beta and slow cortical potentials) demonstrating distinct neurophysiological mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The usage of neurofeedback in children with ADHD: the method and its evaluation]. Gevensleben, H., Moll, GH., Rothenberger, A., et al.[2019]

A novel neurofeedback protocol was tested on 34 depressed and 19 healthy adolescents, showing that neurofeedback can enhance brain activity in regions related to self-processing and emotion regulation, particularly the amygdala and hippocampus.

The study found that while depressed adolescents had different brain activity patterns compared to healthy controls during neurofeedback, the training successfully engaged brain circuits that could potentially improve emotional regulation and self-recognition in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and neuroplasticity of visual self-processing in depressed and healthy adolescents: A preliminary study. Quevedo, K., Liu, G., Teoh, JY., et al.[2020]

In a study involving 41 children with ADHD, EEG neurofeedback did not show a significant improvement in ADHD symptoms compared to placebo neurofeedback, indicating it may not be an effective treatment option.

Both treatment groups experienced a general improvement in ADHD symptoms over time, but there were no significant differences between the groups, and no clinically relevant side effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. van Dongen-Boomsma, M., Vollebregt, MA., Slaats-Willemse, D., et al.[2015]

Neurofeedback training has shown promise as an additional treatment for major depressive disorder (MDD), with 24 studies involving 480 patients indicating that participants experienced greater symptom improvement compared to control groups.

Despite the positive findings, many studies lacked adherence to high-quality research standards, highlighting the need for better experimental designs and reporting practices in future neurofeedback research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback training in major depressive disorder: A systematic review of clinical efficacy, study quality and reporting practices. Trambaiolli, LR., Kohl, SH., Linden, DEJ., et al.[2021]

Real-time fMRI can help patients learn to self-regulate brain circuits related to emotion and depression, showing promise as a new approach to treating affective disorders.

Initial results from fMRI-based neurofeedback (fMRI-NF) in depression are encouraging, but further clinical trials are needed to establish its efficacy and to develop practical applications for everyday use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. Linden, DE.[2021]

A structured neurofeedback training program using electroencephalography showed some positive effects on attentional performance in 24 children and adolescents with ADHD, particularly in reducing reaction times in attention tasks after 20 sessions.

While the results indicated improvements in attention, the effects were generally small and preliminary, highlighting the need for larger studies with control groups to better assess the efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up. Albrecht, JS., Bubenzer-Busch, S., Gallien, A., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Quantitative EEG and neurofeedback in children and adolescents: anxiety disorders, depressive disorders, comorbid addiction and attention-deficit/hyperactivity disorder, and brain injury. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Neural Activity Associated with Symptoms Change in Depressed Adolescents following Self-Processing Neurofeedback. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[The usage of neurofeedback in children with ADHD: the method and its evaluation]. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Neurofeedback and neuroplasticity of visual self-processing in depressed and healthy adolescents: A preliminary study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback training in major depressive disorder: A systematic review of clinical efficacy, study quality and reporting practices. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Applicability of brain wave biofeedback to substance use disorder in adolescents. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial into the effects of neurofeedback, methylphenidate, and physical activity on EEG power spectra in children with ADHD. [2019]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up. [2020]