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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this research proposal is to examine the combined effects of an integrative approach including biofeedback and breathing practices (Healing Minds) on severity of Attention Deficit Hyperactivity Disorder (ADHD) in youth 6-18 years of age. The investigators hypothesize that ADHD severity will be significantly reduced and Heart Rate Variability (HRV) increased after participation in the 10-week intervention. The investigators also propose that ADHD severity in those patients with prescribed medication but poorly-controlled ADHD will demonstrate the greatest improvement compared to those not prescribed medication and those who have well-controlled ADHD. Our specific aims are as follows: AIM I. Conduct a randomized, placebo-controlled trial (RCT) to examine the effects of a 10-week integrative intervention (Healing Minds) that includes Heart Math Biofeedback and Breathing Practices on ADHD severity and HRV in children and adolescents 6-18 years of age diagnosed with ADHD (N=40). Participants randomized to placebo will be placed on a delayed intervention waiting list and will receive the 10-week Healing Minds intervention afterwards. Hypothesis I: ADHD severity will be significantly reduced and HRV increased following the 10-week Healing Minds Intervention in children and adolescents, 6-18 years of age diagnosed with ADHD compared to a placebo condition AIM Ia. Observe the effects of the Healing Minds intervention in the following sub-groups of youth: ADHD without medication (well versus poorly controlled) ADHD with medication (well versus poorly controlled) Hypothesis Ia: Participants without medication will experience a significantly greater reduction in ADHD severity compared to those with medication. Poorly controlled participants with medication will experience the greatest reduction in ADHD severity. AIM Ib. Explore the effects of the intervention on related mental health conditions: PTSD Anxiety Resilience

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 data supports the effectiveness of the treatment Healing Minds, Heart Math 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 biofeedback, has shown benefits for 70-80% of patients with ADHD, indicating potential effectiveness for similar treatments. ^{1 2 3 4 5}

Is biofeedback and breathing practices safe for treating ADHD?

Research on EEG biofeedback, a type of biofeedback, suggests it is generally safe for treating ADHD, with studies showing positive clinical responses in many patients. However, more studies are needed to confirm its safety and effectiveness. ^{1 6 7 8 9}

How is the treatment Healing Minds different from other ADHD treatments?

Healing Minds, which involves biofeedback and breathing practices, is unique because it focuses on using physiological feedback to help manage ADHD symptoms, unlike traditional treatments that often rely on medication. This approach aims to improve attention and behavior by training individuals to regulate their physiological responses, offering a non-drug alternative to stimulant medications. ^{1 8 9 10 11}

Research Team

Inara McMaster, MD

Principal Investigator

Hoskinson Health and Wellness Clinic

Eligibility Criteria

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 am a child or teenager.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

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

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

In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. [2022]

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

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

4. United States 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]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Neurofeedback as ADDH therapy]. [2011]

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

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

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

Electroencephalographic biofeedback in the treatment of attention-deficit/hyperactivity disorder. [2019]

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

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

10. Germany pubmed.ncbi.nlm.nih.gov

Neurofeedback treatment of children with attention deficit hyperactivity disorder. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Neurofeedback combined with training in metacognitive strategies: effectiveness in students with ADD. [2019]