Current Clinical Trials
The purpose of this research study and clinical trials: to demonstrate the effectiveness of the 5 Step Neurocycle Program through the use of the latest brain imaging technology, blood tests and wellbeing scales as an affordable, easily accessible and applicable alternative to psychotropic medication to help relieve mental ill-health problems such as anxiety, depression and intrusive thoughts.
Throughout our research trial, we saw significantly positive changes in the experimental group on a cellular level (based on changes in telomeres, the caps on chromosomes), in electrical activity in the brain (based on QEEG-measured changes in the brain), in psychosocial profiling (based on changes in psychological scales and narratives), and in blood tests (including changes cortisol and homocysteine levels). Our results also indicate that there were positive changes in the nonconscious mind (QEEG), conscious mind (LMM), body (telomeres and blood) and the whole person (narrative). The subjects in our experimental group, by using the 5 steps of mind-management in the NEUROCYCLE app, improved their mental health, brain health, blood physiology and cellular health. Preliminary results from our trial also demonstrated a significant reduction in depression and anxiety, through mind-management, by up to 81%, in the experimental group compared with the control group. The experimental subjects were learning how to embrace and make the anxiety and depression work for them and not against them, which is a much more sustainable approach than simply trying to numb or remove emotions and feelings completely.
While Dr. Leaf's team is not allowed publish their research findings ahead of the peer reviewed journal article, here is some information on their current research projects. Data is analyzed by an independent research and analysis consulting firm, Elite Research, LLC (www.eliteresearch.com).
National Study of NeurocycleTM Users:
The national study of NeurocycleTM app users is a longitudinal multi-year study aimed to assess the impact of the NeurocycleTM program on pro-mindfulness factors – including resilience, gratitude, autonomy, hope, confidence, and the behavior to think, feel, and choose positive mental perspectives – by measuring changes in the Leaf Mind Management (LMM) Scales (autonomy, awareness, toxic thoughts and isolation, toxic stress and anxiety, barriers and challenges, empowerment and life satisfaction) among U.S. adults ages 18 to 80 who use the NeurocycleTM app program.
The study will provide a detailed picture of changes in mindfulness, mind management skills, and mental-health-related issues in adult populations. The data will be used to identify needs and priorities, benchmark against various population characteristics, evaluate programs and policies, plan for services and programs, and advocate for resources. Data collection happens within the app every 21 days for the 20 LMM items and the 8 pro-mindfulness factors as well as a web-based survey (psychdata.com) for user demographics, treatment history, and program experience. Users are invited and reminded to participate in the survey via emails. The data collection protocol begins with an email invitation, and non-responders are contacted up to three times by email reminders spaced by 5-7 days each. Reminders are only sent to those who have not yet completed the survey. Each communication contains a URL that participants use to gain access to the survey.
Quantitative Electroencephalography (QEEG) Assessment of the NeurocycleTM
Globally, mental health concerns are growing. The World Health Organization (2022) has reported that there was a 13% rise in mental health conditions and substance abuse disorders from 2007 to 2017. Despite this, current pharmacological treatments do not offer lasting treatment or resolution for these disorders (Turner, 2021) and much more neuroscientific research is needed to inform clinical practice and the treatment of mental illness (Ivanov & Schwartz, 2021). Over the past few decades, many studies have contributed to utilizing electroencephalography (EEG) measurements to assess mental health through correlations between historically pre-defined frequency bands in the power spectrum –alpha, beta, delta, theta, and gamma – and specific mental health conditions (Newson & Thiagarajan, 2019). For instance, low gamma waves and high beta waves can be associated with ADHD and anxiety, respectively, while higher theta and alpha waves can reduce generalized anxiety disorder (Dadashi et al., 2015). However, a lack of standardization across the field and the association of a single frequency with multiple mental health conditions has necessitated more research into the measurement and meaning of each frequency at various levels (Newson & Thiagarajan, 2019). Specifically, Newson and Thiagarajan (2019) call for researchers to contribute to the creation of a large QEEG database of data that might be assessed altogether.
The current research study seeks to answer this call. QEEG measurements of 11 NeurocycleTM participants were performed before using the NeurocycleTM, after the first 21 days, and after the final 63 days to assess mental health improvements. In treatment vs. control comparisons, participants significantly improved on performance of all five brain waves’, supporting a likely decrease in anxiety and stress, as well as an increase in relaxation, learning, and autonomy. This was confirmed in the psychosocial assessments conducted alongside the QEEG tests, which revealed a corresponding improvement in decreased toxic thoughts, isolation, and overall LMM score as well as increased autonomy, awareness, empowerment, life satisfaction, and ability to manage life obstacles. These results strengthen existing research that has established the same relationships. These findings show that the NeurocycleTM has an impact on mental health from a whole-brain perspective. Continued research will increase the number of participants to assess continuance of the correlations amongst a larger sample.
Teacher Mindfulness Training using the NeurocycleTM
Key findings from the 2021 State of the U.S. Teacher Survey (Steiner & Woo, 2021) have revealed that job-related stresses, which have been amplified with COVID-19 measures, are critically threatening the teacher supply. While there are many kinds of therapies and treatments designed to support educators, mindfulness has shown specific efficacy for teachers, students, and educational settings due to its ease of implementation and near immediate positive impacts. However, leading mindfulness researchers have called for an instructional tool that not only teaches mindfulness practices, but also covers and assesses mindfulness’ necessary counterparts: self-regulation and self-management and emotional, cognitive, and behavioral flexibility (resilience). The current research presents a live, six-session training program that answers this call, teaching teachers how to increase their autonomy, awareness, and empowerment/life satisfaction while lowering their toxic thoughts, stress, and perceived barriers and challenges via mindfulness training and practice. Teachers were provided with webinars covering the rationale behind and 5-step process of the NeurocycleTM, a tool for mental health detoxing and management. Their mindfulness development and mental health were assessed by the Leaf Mind Management (LMM) scale before and after the program. Results revealed statistically increased levels of awareness, autonomy, and empowerment and significantly decreased toxic mental health factors. Participants’ feedback revealed that the program made it easy to apply their learning in their work and school lives, and that they desired further future mindfulness trainings via this program structure. These results show the promise of the NeurocycleTM as a stress management and instructional efficacy support tool for educators that also provides a medium for measuring results and maintenance.
Leaf Mind Management (LMM) Scale Validation
A critical step for improving mental health is developing non-pharmacological therapies that can treat anxiety and depression effectively without reliance on pharmacological treatments and the accompanying risks for side effects and interactions. To facilitate non-pharmacological therapy for mental health, individuals require specific knowledge, attitudes, and behaviors that promote self-regulation skills and increased awareness, processing, reconceptualization, and control of reactions and responses to the circumstances of life that cause feelings of anxiety and depression. Answering Shapiro et al.’s (2006) seminal call for a measurement that assesses not only mindfulness but also its necessary mediators – self-regulation, resilience, reconceptualization, and exposure – the Leaf Mind Management Tool was created. The researchers conducted face and content validity assessments to ensure a strong initial approach to question selection. A final set of 71 items was selected for the initial questionnaire, and exploratory factor analysis (EFA) and confirmatory factor analyses (CFA) found 20 items nested within six factors that explained 71.9% of the overall variance. Each of the six factors represents a set of knowledge, attitudes, or behaviors related to self-regulation and control. Study 1’s findings suggested that these 20 questions forming the Leaf Mind Management (LMM) survey tool have both structural validity and consistent reliability across both samples. Implementing the LMM through the NeurocycleTM app, the findings of Study 2 found that test-retest reliability for all six LMM subscales was strong and that construct validity existed with established anxiety, depression, and well-being measures. Construct validity with blood measures also revealed significant relationships between the toxic stress and anxiety subscale and homocysteine levels and DHEA/cortisol ratios.