Neurofeedback for Adolescent Depression

Overseen By Mary Woody, Phd

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to predict and possibly prevent depression in teenage girls using neurofeedback, a therapy that uses real-time displays of brain activity. Neurofeedback shows participants their brain's response to negative distractions and helps them focus better by reducing attention to these distractions. The goal is to identify girls at high risk for depression and develop personalized treatments for them. Girls aged 13 to 15 who have never been diagnosed with depression or taken antidepressants are ideal candidates for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research in mental health prevention.

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.

What prior data suggests that this neurofeedback technique is safe for adolescents?

Research shows that neurofeedback is generally easy for people to handle. Studies suggest that neurofeedback can help with depression by reducing symptoms and improving brain function. One review found that EEG-based neurofeedback training can significantly boost mood and thinking skills.

Overall, reports of side effects are rare, making neurofeedback a safe choice for many. While more research is needed for firm conclusions, current evidence suggests that neurofeedback is a safe and possibly effective treatment for depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neurofeedback is unique because it uses real-time feedback from brain wave activity to help adolescents manage their depression by reducing attention to negative distractions. Unlike traditional treatments such as antidepressants or cognitive-behavioral therapy, which can take weeks to show effectiveness, neurofeedback offers a non-invasive and immediate approach to altering brain activity patterns. Researchers are excited about this treatment because it empowers participants to actively engage in their mental health management, potentially leading to quicker and more personalized improvements in mood and attention.

What evidence suggests that neurofeedback is effective for adolescent depression?

Research has shown that neurofeedback might be a promising way to treat depression. One study demonstrated that ten sessions of a specific type of neurofeedback greatly reduced symptoms in people with major depressive disorder. In this trial, participants will receive neurofeedback, which provides real-time feedback on brain activity to help individuals learn to control it. This method has shown potential in improving focus and reducing negative thoughts, both linked to depression. While more research is needed, early findings suggest it could be a useful tool for managing depression in teenagers. ^{1 3 6 7 8}

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 (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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4892319/

Neurofeedback: A Comprehensive Review on System Design ... Neurofeedback is a kind of biofeedback, which teaches self-control of brain functions to subjects by measuring brain waves and providing a feedback signal.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9790100/

Comparing LORETA Z Score Neurofeedback and Cognitive ... The results showed that both treatments were effective during the time (P<0.001 in all variables) for decreasing craving, improving attentional bias, and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724000284

The effects of swLORETA Z-score neurofeedback for ... Ten sessions of swLZNFB reduced clinical symptoms and atypical brain activities, it serves as a potential psychological intervention for patients with MDD.

4. chadd.org chadd.org/about-adhd/neurofeedback-eeg-biofeedback/

Neurofeedback (EEG Biofeedback) The concept of neurofeedback as an intervention for ADHD is based on data showing that many individuals with ADHD have more slow-wave (especially theta) power ...

5. nature.com nature.com/articles/s41398-024-03066-9

Whole-brain mechanism of neurofeedback therapy This study aimed to delineate the whole-brain mechanisms underpinning the effects of rtfMRI-NF on repetitive negative thinking in depression.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7878101/

The Current Evidence Levels for Biofeedback and ... This article is aimed at showing the current level of evidence for the usage of biofeedback and neurofeedback to treat depression

7. sciencedirect.com sciencedirect.com/science/article/pii/S092549272300001X

Review of EEG-based neurofeedback as a therapeutic ... The recent literature on EEG-NF training for treating depression is reviewed. •. Patients with depression have shown significant cognitive, clinical and ...

8. anthem.com anthem.com/medpolicies/abc/active/gl_pw_e003054.html

CG-MED-97 Biofeedback and Neurofeedback This document addresses biofeedback, a treatment that provides an individual with information about physiological processes that are normally involuntary.