Biofeedback and Breathing Practices for ADHD

Overseen By Julie Weisz

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Hoskinson Health and Wellness Clinic

Disqualifiers: Severe mental illness, Suicidal ideology, Psychosis, Severe autonomic disorders, Neurological conditions, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether biofeedback and breathing exercises, known as Healing Minds, can reduce ADHD symptoms in children and teens. Researchers believe these practices will lower ADHD severity and improve heart rate variability, a measure of heart health. They are particularly interested in whether children on ADHD medication but still experiencing symptoms might benefit the most. Children and teens aged 6-18 with a confirmed ADHD diagnosis are suitable candidates for this study. As an unphased trial, this study offers participants a unique opportunity to explore innovative non-medication treatments for ADHD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It seems to include participants both with and without medication, so you might be able to continue your current treatment.

What prior data suggests that this integrative approach is safe for children and adolescents with ADHD?

Research has shown that biofeedback and breathing exercises, such as those in the Healing Minds program, are generally safe for treating ADHD. Studies on EEG biofeedback, a similar method, have demonstrated positive results in many individuals with ADHD. These practices are usually well-tolerated. No major side effects have been reported in these studies, indicating that these treatments are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Healing Minds because it offers a non-pharmaceutical approach to treating ADHD. Unlike traditional treatments that often rely on medication to manage symptoms, Healing Minds uses a combination of Heart Math biofeedback and specialized breathing practices. This method aims to help individuals gain better control over their physiological responses, potentially reducing ADHD symptoms without the side effects associated with medication. By focusing on self-regulation and mindfulness, Healing Minds provides a holistic alternative that could empower individuals with ADHD to manage their condition more naturally.

What evidence suggests that the Healing Minds intervention could be effective for ADHD?

Research shows that biofeedback, especially when combined with breathing exercises, can help reduce hyperactivity symptoms in people with ADHD. Studies have found that these techniques may improve heart rate variability (HRV), a measure of stress response. In this trial, participants in the Healing Minds arm will receive ten weekly treatments using these methods to potentially lessen ADHD severity. While detailed data on this specific approach is still being gathered, early results suggest it could effectively manage ADHD symptoms. These techniques aim to provide additional benefits for those whose ADHD is not well-controlled, possibly enhancing the effectiveness of existing medication. ^{1 2 3 4 5}

Who Is on the Research Team?

Inara McMaster, MD

Principal Investigator

Hoskinson Health and Wellness Clinic

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 6-18 with ADHD. It's especially focused on those who may or may not be taking medication for ADHD, including those whose symptoms are not well-managed by their current treatment.

Inclusion Criteria

I have been diagnosed with ADHD according to the DSM-5-TR.

I am a child or teenager.

I am between 6 and 18 years old.

Exclusion Criteria

Severe, uncontrolled mental illness including depression and panic disorders

Pregnant or nursing females may not participate due to required tests for the study.

Suicidal ideology

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Healing Minds intervention, which includes Heart Math Biofeedback and Breathing Practices, for 10 weeks

10 weeks

10 weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healing Minds

Trial Overview The 'Healing Minds' intervention, which includes biofeedback and breathing practices over a 10-week period, is being tested to see if it can reduce the severity of ADHD symptoms and increase heart rate variability (HRV) compared to a placebo.

How Is the Trial Designed?

Group I: Healing Minds Experimental Treatment 1 Intervention

Ten weekly treatments of Heart Math Biofeedback and Breathing Practices

Group II: Control Active Control 1 Intervention

Waiting List Delayed Intervention

Who Is Running the Clinical Trial?

Hoskinson Health and Wellness Clinic

Lead Sponsor

Trials

2

Recruited

80+

Published Research Related to This Trial

In a study of 104 children aged 7 to 11 with ADHD, those who received neurofeedback showed sustained improvements in attention and executive functioning six months after a 40-session intervention, with effect sizes indicating significant benefits over cognitive training and control groups.

Neurofeedback participants maintained their stimulant medication dosage, while those in cognitive training and control groups required significant increases in medication, suggesting that neurofeedback may be a more effective treatment option for managing ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. Steiner, NJ., Frenette, EC., Rene, KM., et al.[2022]

In a review of 111 subjects with Attention Deficit Disorder (ADD) who underwent 40 sessions of neurofeedback combined with metacognitive strategy training, significant improvements were observed in ADD symptoms, academic performance, and intelligence scores, with an average IQ gain of 12 points.

The study noted a decrease in theta/beta EEG ratio, indicating enhanced brain activity associated with focus, suggesting that this combined intervention may be effective for managing ADD symptoms, although further controlled research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback combined with training in metacognitive strategies: effectiveness in students with ADD. Thompson, L., Thompson, M.[2019]

A review of 36 studies on biofeedback as a treatment for hyperactivity suggests that while biofeedback alone has not been effectively evaluated, it shows potential when combined with other techniques.

Methodological issues in existing studies limit the ability to generalize findings to hyperactive populations, indicating a need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback as a treatment for childhood hyperactivity: a critical review of the literature. Lee, SW.[2009]

EEG biofeedback has been found to be 'probably efficacious' in treating ADHD, showing improvements in attention, behavioral control, and academic performance based on a review of multiple studies.

Approximately 75% of patients reported significant clinical improvement with EEG biofeedback, but more randomized controlled studies are needed to better understand its effectiveness in broader clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalographic biofeedback in the treatment of attention-deficit/hyperactivity disorder. Monastra, VJ., Lynn, S., Linden, M., et al.[2019]

In a study involving 144 children aged 7 to 10 with moderate to severe ADHD, theta/beta-ratio neurofeedback (NF) did not show a significant advantage over a control treatment in reducing inattention, with both groups improving similarly over time.

While both groups reported improvements, the NF group required significantly less medication at the 13-month follow-up, suggesting a potential benefit in medication management, even though the specific efficacy of NF was not established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. [2022]

EEG biofeedback (neurofeedback) training over five months in 12 children with ADHD led to significant improvements in brain activity patterns, specifically increased beta activity and decreased theta activity, which are associated with better attention and focus.

Post-treatment assessments showed that children not only had improved EEG patterns but also higher cognitive scores, better school performance, and enhanced social skills, indicating that neurofeedback is an effective and non-invasive treatment option for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback treatment of children with attention deficit hyperactivity disorder. Pop-Jordanova, N., Markovska-Simoska, S., Zorcec, T.[2022]

The increasing incidence of stress-related disorders in children highlights the need for effective stress management techniques, which can be taught through hypnotherapy and biofeedback in primary care settings.

Hypnotherapy and biofeedback can help children develop self-regulation skills, leading to improved cognitive function and self-image, as demonstrated through case examples in the article.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Hypnosis and Biofeedback in Primary Care Pediatrics. Thomson, L.[2019]

Research over the past two decades indicates that 70-80% of patients with ADHD show improvement from EEG biofeedback (neurofeedback) training.

Recent studies with control groups support earlier findings, but the lack of placebo-controlled studies means neurofeedback can only be considered probably effective for ADHD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neurofeedback as ADDH therapy]. Stjernholm, O.[2011]

EEG biofeedback is a nonpharmacologic treatment for ADHD that has shown a positive clinical response in about 75% of patients in controlled studies, indicating its potential efficacy.

The treatment is considered 'probably efficacious' according to established guidelines, making it a viable option for patients who do not respond to stimulant medications, although more randomized controlled trials are needed for further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalographic biofeedback (neurotherapy) as a treatment for attention deficit hyperactivity disorder: rationale and empirical foundation. Monastra, VJ.[2009]

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]

EEG biofeedback, or neurofeedback, is an effective alternative treatment for ADHD, showing efficacy comparable to stimulant medications in large-scale clinical trials.

Different EEG biofeedback protocols, such as single-channel and interhemispheric approaches, are widely used and supported by substantial clinical evidence, indicating their reliability in treating ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG biofeedback in the treatment of attention deficit hyperactivity disorder. Friel, PN.[2009]

Citations

1. withpower.com withpower.com/trial/biofeedback-and-breathing-practices-for-adhd-ebd2a

Biofeedback and Breathing Practices for ADHD Research suggests that biofeedback, when combined with other techniques, may help reduce some symptoms of hyperactivity. Additionally, neurofeedback, a type of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06648252?term=ADHD&aggFilters=status:rec&rank=7

Healing Minds: Biofeedback and Breathing Practices in ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06648252/healing-minds-biofeedback-and-breathing-practices-in-children-and-adolescents-with-adhd

Healing Minds: Biofeedback and Breathing Practices in ... The investigators hypothesize that ADHD severity will be significantly reduced and Heart Rate Variability (HRV) increased after participation in ...

4. medpagetoday.com medpagetoday.com/clinical-trial-finder/study/nct06648252

Healing Minds: Biofeedback and Breathing Practices in ... Study Overview. Brief Summary. The objective of this research proposal is to examine the combined effects of an integrative approach including biofeedback ...

5. clinconnect.io clinconnect.io/trials/NCT06648252

Healing Minds: Biofeedback and Breathing Practices in The goal is to see if this 10-week program can improve ADHD symptoms and heart rate variability (a measure of how well the body responds to stress) compared to ...