Biofeedback and Lifestyle Interventions for ADHD

JW
SD
Overseen BySanjay Dhar, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Hoskinson Health and Wellness Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a combined approach of biofeedback, breathing exercises, nutrition, and exercise can help manage ADHD symptoms in kids and teens. Biofeedback uses electronic devices to monitor and control body functions like heart rate and muscle tension, helping participants become more aware and in control of their bodies. The trial also includes breathing techniques, dietary guidance, and exercise advice tailored to support heart and muscle health. It seeks children and teens aged 7-18 with ADHD who may still struggle with symptoms despite medication. Participants with uncontrolled mental illnesses or severe health conditions are not eligible. As an unphased trial, this study offers a unique opportunity to explore innovative, non-pharmaceutical approaches to managing ADHD symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems that participants with ADHD who are on medication can still join, especially if their symptoms are not well-controlled.

What prior data suggests that this biofeedback and lifestyle intervention is safe for children with ADHD?

Research has shown that biofeedback, a key component of the Healing Minds II treatment, is generally safe for individuals with ADHD. Studies have found that many respond well to this method. Biofeedback employs special equipment to help individuals better control body functions like heart rate and muscle tension. Most participants tolerate this well without negative side effects.

The trial also includes breathing exercises, nutrition advice, and exercise guidance. These methods commonly improve overall health and typically do not cause harmful side effects. The trial's "not applicable" phase focuses on understanding how the treatment works rather than solely assessing its safety. This often suggests that researchers are confident about its safety based on previous studies and current knowledge.12345

Why are researchers excited about this trial?

Unlike traditional ADHD treatments that often rely on medications like stimulants (e.g., Adderall, Ritalin) or non-stimulants (e.g., Strattera), Healing Minds II offers a unique approach by combining biofeedback and lifestyle interventions. Researchers are excited because this method focuses on training individuals to control their own physiological responses, potentially reducing symptoms without the need for medication. This non-invasive approach could empower patients with self-regulation skills, offering an alternative for those who prefer or require non-medication-based options.

What evidence suggests that this biofeedback and lifestyle intervention is effective for ADHD?

Research has shown that techniques like biofeedback and breathing exercises, used in the Healing Minds II program, can help manage ADHD symptoms. These methods provide real-time feedback on heart rate and muscle tension, enabling individuals to better control their body functions. Early results suggest these techniques might improve focus and reduce impulsive behavior in people with ADHD. Although direct evidence for Healing Minds II is limited, its components—biofeedback, breathing exercises, nutrition, and exercise—have each shown promise in managing ADHD symptoms. Breathing exercises, in particular, are believed to enhance calmness and focus, benefiting those with ADHD.13678

Who Is on the Research Team?

IM

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 7-18 with ADHD. It's designed to help those who might not be managing their symptoms well, even if they're on medication. Participants will need to commit to a 6-month program involving biofeedback, breathing exercises, nutrition, and physical activity counseling.

Inclusion Criteria

I am between 7 and 18 years old.
I am a child or teenager.
I have been diagnosed with ADHD according to DSM-5-TR.

Exclusion Criteria

Severe, uncontrolled mental illness including depression, panic disorders
Suicidal ideology
Psychosis
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

Phase I: Biofeedback and Breathing Practices

Participants receive weekly sessions of biofeedback and breathing practices

12 weeks
12 visits (in-person)

Phase II: Nutrition and Exercise Counseling

Participants receive monthly sessions of nutrition and exercise counseling

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Healing Minds II
Trial Overview The Healing Minds II study tests an integrative approach combining biofeedback (using equipment to monitor physiological responses), specialized breathing practices, tailored nutritional guidance based on the Mediterranean Diet, and exercise advice following expert guidelines—all aimed at reducing ADHD symptoms.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoskinson Health and Wellness Clinic

Lead Sponsor

Trials
2
Recruited
80+

Citations

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 ...
Biofeedback and Breathing Practices for ADHDHealing Minds, which involves biofeedback and breathing practices, is unique because it focuses on using physiological feedback to help manage ADHD symptoms, ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/16961429/
Effectiveness outcomes in attention-deficit/hyperactivity ...This article will discuss the methodology needed to demonstrate empirically the impact of treatment on actual burden of illness in practice.
Neurofeedback for Attention-Deficit/Hyperactivity Disorder ...Conclusion. Evidence from well-controlled trials with probably blinded outcomes currently fails to support neurofeedback as an effective treatment for ADHD.
Biofeedback and Lifestyle Interventions for ADHDThe investigators hypothesize that ADHD symptoms and severity, impulsivity and attention will be significantly improved and coherence increased after ...
Healing Minds: Biofeedback and Breathing Practices in ...The objective of this research proposal is to examine the combined effects of an integrative approach including biofeedback and breathing ...
NCT05200936 | Safety and Efficacy of Low Dose MM-120 ...This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM-120 (20 μg) compared with a placebo administered ...
Safety and Efficacy of Repeated Low-Dose LSD for ADHD ...This double-blind, placebo-controlled randomized clinical trial determines the safety and efficacy of repeated low doses of lysergic acid ...
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