Biofeedback and Breathing Practices for ADHD
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hoskinson Health and Wellness Clinic
Disqualifiers: Severe mental illness, Suicidal ideology, Psychosis, Severe autonomic disorders, Neurological conditions, others
No Placebo Group
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.
12345Is 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.
16789How 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.
1891011Eligibility 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
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Healing MindsExperimental Treatment1 Intervention
Ten weekly treatments of Heart Math Biofeedback and Breathing Practices
Group II: ControlActive Control1 Intervention
Waiting List Delayed Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hoskinson Health and Wellness ClinicGillette, WY
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Who Is Running the Clinical Trial?
Hoskinson Health and Wellness ClinicLead Sponsor
References
Biofeedback as a treatment for childhood hyperactivity: a critical review of the literature. [2009]Hyperactivity is a significant problem for which no causal theories have been unequivocally substantiated and one in which treatment approaches have met with limited success. Recent research in behavioral medicine has brought biofeedback into use as a treatment for disorders that are mediated by physiologic functioning, with hyperactivity as one such disorder. 36 studies are reviewed in which biofeedback was used as a treatment for hyperactivity. This review indicated that biofeedback treatments alone have not been effectively evaluated, and methodological problems with the current studies severely limit generalizations that may be made to hyperactive populations. Biofeedback in conjunction with other techniques appears to have promise for reducing some of the behavioral symptoms of the hyperactivity syndrome. Directions for further research are presented.
In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. [2022]To evaluate sustained improvements 6 months after a 40-session, in-school computer attention training intervention using neurofeedback or cognitive training (CT) administered to 7- to 11-year-olds with attention-deficit/hyperactivity disorder (ADHD).
Combining Hypnosis and Biofeedback in Primary Care Pediatrics. [2019]The incidence of stress-related, psychophysiological disorders in children is increasing. A goal of both parenting and pediatric health care is to teach children the skills of problem solving, affective and physical regulation, and techniques to better manage stress. In primary care pediatrics, both hypnotherapy and biofeedback can be used to teach psychophysiological self-regulation through relaxation and stress management affecting cognitive change and improving the child's self-image. This article uses case examples to review how hypnosis and relatively inexpensive biofeedback equipment can be implemented in primary care pediatrics to teach psychophysiological self-regulation through relaxation and stress management to effect cognitive change and improving the child's self-image.
Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. [2022]To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback [NF]) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.
[Neurofeedback as ADDH therapy]. [2011]The article is a review of the past two decades of research on Attention Deficit Hyperactive Disorder (ADHD) and the documented effect of training with EEG biofeedback, often called neurofeedback. Research during the past twenty years seems to confirm that 70-80% of patients benefit from neurofeedback training. Research from the last ten years, using control groups, comparison between different kinds of treatment and psychometric testing, has to some degree confirmed the early findings. Due to the lack of placebo studies or studies comprising false feedback, neurofeedback can only be characterized as probably effective.
Electroencephalographic biofeedback (neurotherapy) as a treatment for attention deficit hyperactivity disorder: rationale and empirical foundation. [2009]During the past three decades, electroencephalographic (EEG) biofeedback has emerged as a nonpharmacologic treatment for attention-deficit/hyperactivity disorder (ADHD). This intervention was derived from operant conditioning studies that demonstrated capacity for neurophysiologic training in humans and other mammals and targets atypical patterns of cortical activation that have been identified consistently in neuroimaging and quantitative EEG studies of patients diagnosed with ADHD. This article presents the rationale for EEG biofeedback and examines the empirical support for this treatment using efficacy guidelines established by the Association for Applied Psychophysiology and Biofeedback and the International Society for Neuronal Regulation. Based on these guidelines, EEG biofeedback is considered to be "probably efficacious" for the treatment of ADHD and merits consideration as a treatment for patients who are stimulant "nonresponders." Although research findings published to date indicate positive clinical response in approximately 75% of patients treated in controlled group studies, additional randomized, controlled trials are needed to provide a better estimate of the robustness of this treatment.
A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]A double-blind, randomized, placebo-controlled study was designed to assess the efficacy and safety of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD). The study started in August 2008 and ended in July 2012 and was conducted at Karakter Child and Adolescent Psychiatry University Centre in Nijmegen, The Netherlands.
Electroencephalographic biofeedback in the treatment of attention-deficit/hyperactivity disorder. [2019]Historically, pharmacological treatments for attention-deficit/hyperactivity disorder (ADHD) have been considered to be the only type of interventions effective for reducing the core symptoms of this condition. However, during the past three decades, a series of case and controlled group studies examining the effects of EEG biofeedback have reported improved attention and behavioral control, increased cortical activation on quantitative electroencephalographic examination, and gains on tests of intelligence and academic achievement in response to this type of treatment. This review paper critically examines the empirical evidence, applying the efficacy guidelines jointly established by the Association for Applied Psychophysiology and Biofeedback (AAPB) and the International Society for Neuronal Regulation (ISNR). On the basis of these scientific principles, EEG biofeedback was determined to be "probably efficacious" for the treatment of ADHD. Although significant clinical improvement was reported in approximately 75% of the patients in each of the published research studies, additional randomized, controlled group studies are needed in order to provide a better estimate of the percentage of patients with ADHD who will demonstrate such gains in clinical practice.
EEG biofeedback in the treatment of attention deficit hyperactivity disorder. [2009]Electroencephalogram (EEG) biofeedback, also known as neurofeedback, is a promising alternative treatment for patients with attention deficit/hyperactivity disorder (AD/HD). EEG biofeedback therapy rewards scalp EEG frequencies that are associated with relaxed attention, and suppresses frequencies associated with under- or over-arousal. In large-scale clinical trials, the efficacy of EEG biofeedback for AD/HD is comparable to that of stimulant medications. Many different EEG biofeedback protocols for AD/HD are available. Single-channel protocols developed by Lubar and interhemispheric protocols developed by the Othmers are widely practiced and supported by large-scale clinical studies.
Neurofeedback treatment of children with attention deficit hyperactivity disorder. [2022]Biofeedback is a modern computer-related technique used for assessment and therapy of many psychophysiological disorders, especially stress-related ones. After a short overview of the basic concepts of biofeedback, in this study the application of EEG biofeedback (neurofeedback) in the assessment of and therapy for attention deficit hyperactivity disorders (ADHD) is presented and discussed.
Neurofeedback combined with training in metacognitive strategies: effectiveness in students with ADD. [2019]A review of records was carried out to examine the results obtained when people with Attention Deficit Disorder (ADD) received 40 sessions of training that combined neurofeedback with the teaching of metacognitive strategies. While not a controlled scientific study, the results, including pre- and post-measures, are consistent with previously published research concerning the use of neurofeedback with children. A significant addition is that a description of procedures is included. The 111 subjects, 98 children (age 5 to 17) and 13 adults (ages 18 to 63), attended forty 50-min sessions, usually twice a week. Feedback was contingent on decreasing slow wave activity (usually 4-7 Hz, occasionally 9-11 Hz) and increasing fast wave activity (15-18 Hz for most subjects but initially 13-15 Hz for subjects with impulsivity and hyperactivity). Metacognitive strategies related to academic tasks were taught when the feedback indicated the client was focused. Some clients also received temperature and/or EDR biofeedback during some sessions. Initially, 30 percent of the children were taking stimulant medications (Ritalin), whereas 6 percent were on stimulant medications after 40 sessions. All charts were included where pre- and post-testing results were available for one or more of the following: the Test of Variables of Attention (TOVA, n = 76), Wechsler Intelligence Scales (WISC-R, WISC-III, or WAIS-R, n = 68), Wide Range Achievement Test (WRAT 3, n = 99), and the electroencephalogram assessment (QEEG) providing a ratio of theta (4-8 Hz) to beta (16-20 Hz) activity (n = 66). Significant improvements (p