Vital Mind Reset: Randomized Clinical Trial

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Summary: This landmark, randomized, controlled clinical trial of our online protocol, Vital Mind Reset, demonstrates the power of lifestyle interventions to significantly relieve depressive symptoms and improve quality of life in as little as 44 days. Click here to find out more.

2020: The Year of Opportunity

2020 has been a year that almost no one could have predicted. Life for many has changed radically, and many more individuals have started to see our broken healthcare system for what it is, an inept behemoth incapable of treating chronic conditions or providing essential guidance regarding truly preventative measures to maintain one’s health.

As more and more individuals awaken to the reality that they can take radical ownership of their health through dietary and lifestyle practices, and that engaged, supportive communities are critical to dispel isolation and fear, there is arguably more hope now than ever before for our world to heal from past and current trauma and to remove unconscious alignments with values that were never really our own.  – Kelly Brogan, MD

The Birth of an Idea

Back in 2018, before any of this COVID-19 hysteria began, I reached out to Dr. Kelly Brogan to share a rather radical idea. At this point in time, I was a 2nd year family medicine resident physician, being swiftly escorted out of traditional medicine by a universe that had distinctly different plans. While I had been studying integrative and functional medicine since the beginning of medical school in 2013, spreading empowerment and education for those wanting to take ownership of their health, I was forced to march along the defined walkways of medical education. With a series of chaotic synchronicities in 2018, however, it finally became clear that my time walking the traditional path was over, and that there were far more important things to be doing than being on-call at 3 AM.

In my proposal to Dr. Brogan, I suggested that we utilize targeted scientific inquiry to further examine the role of her novel community-based online program The Vital Mind Reset (VMR) designed to improve well being and mental health. Up to this point, Dr. Brogan had published 2 case reports detailing remarkable recoveries of individuals finding healing and growth through the VMR program. While these publications served as a scientific act of rebellion against the paradigm of traditional psychiatric care, I felt we could do even more. Without academic resources or the backing of any industry, I suggested that we perform a randomized controlled trial, upping the ante of scientific rigor.

More specifically, I proposed that we study the role of the VMR program to improve quality of life and depressive symptoms in individuals with a history of the DSM-V label Major Depressive Disorder (MDD). Through our randomized study design, we would create 2 groups, one completing the VMR program and one acting as a waitlist control. We would follow all individuals over several weeks, tracking their depressive symptoms, overall symptoms and quality of life to see if, indeed, the VMR program was having a significant treatment effect compared to those continued to receive standard of care.

Lifestyle Medicine Research Design

While the randomized controlled trial is arguably the most rigorous scientific tool available to assess the effects of a certain therapy, traditional medicine utilizes it within a reductionist model, whereby only one intervention (such as a drug) is tested to see if some sort of predefined outcome happens as a result of that intervention. This reductionist model seemingly works for pharmaceutical trials, although scientists avoid trial design that invokes  multiple therapeutic modalities because they cannot readily discern which therapeutic modality caused a specific treatment effect.

There are numerous reasons why lifestyle medicine, a great example of a treatment with multiple therapeutic modalities, is not readily studied like drugs, I hope you can see now why the reductionist model of research design is woefully inadequate to properly explore the impact of lifestyle to support health. What really is so wrong with taking multiple low risk therapies that have each been shown individually to have positive treatment effects and combining them in a synergistic, multimodal program? To me, absolutely nothing.

The Beginning of the VMR Study

Following my research inquiry in 2018, I received a fascinating and exuberant reply from Dr. Brogan. At the time she had no idea who I was. All she knew was that I was a young physician with a crazy idea to study her VMR program. I had no money, no industry backing and no affiliation with any academic institution. I was simply answering my call to the universe.

Over the course of several weeks, we assembled our research team made up of medical students and psychology professionals. As I was familiar with the formal research process involving Institutional Review Boards (IRB) given my previous research endeavours, I developed a protocol and proposal that was eventually approved by an IRB. It was now time to put our efforts to the test. Beginning in late 2018 and early 2019, we enrolled our first study participants. 

What Did We Study?

Through 2019 and early 2020, we enrolled a total of 71 participants between the ages of 20-64 with a history of MDD. Using our simple randomization scheme, these 71 participants were broken into 2 study groups.

  1. A group that completed the entire VMR program (37 people)
  2. A group that was on a wait-list (34 people)

Everyone placed in the VMR program would go on to complete 6 weeks of self-directed work in these domains:

  • Mental health educational material
  • Healthy dietary changes that didn’t just focus on counting calories or rigid meal patterns
  • Sleep hygiene
  • Mindfulness meditation
  • Physical activity
  • Interacting with other people in the program. 

Those placed on the wait-list control group would continue to receive treatment as normal with their respective health care providers, and would be allowed to enter the VMR program at the end of the study. 

Everyone at the start of the study was asked to fill out 3 different questionnaires assessing their health related quality of life, depressive symptoms and overall symptom burden. Following the completion of the approximately 10-week study, all individuals were then asked to complete the same 3 questionnaires once more.

What Did We Find?

After performing the randomization, we found that there were no differences between the two groups at the beginning of the study with regards to participant characteristics such as body mass index (BMI; a way to see if people are in a health weight class respective to their height), current psychiatric medical history, use of psychotropic medications, smoking, alcohol consumption, caffeine use and even dietary supplement use. When looking at the 3 study questionnaires, we found that both groups were statistically equivalent for all measures, with the wait-list group reporting slightly worse depressive symptoms that were not clinically significant.

Upon examining the two groups after the 10-week study,  we saw some truly remarkable findings...

In our first statistical model, we wanted to see the outcomes within each group from the beginning to the end of the trial. Essentially, we compared the control group participants to themselves from the beginning to the end of the study and did the same for those in the VMR group.

When looking at the wait list control group, we noticed that participants had almost no change in how they perceived their quality of life, total symptom burden, or depressive symptoms (baseline was on average rated as moderately severe). This was rather interesting as we had actually expected to see some fluctuation in one of the 3 questionnaires related to the expectancy to participate in the VMR program or because of other changes that could have occurred in the participants’ lives.

When we looked at the scores of the 3 questionnaires in the VMR group, however, we found essentially the exact opposite findings!

  • The VMR group’s quality of life markedly improved, with mental health seeing one of the biggest improvements.
  • The VMR group’s depressive symptoms (that were rated as moderate depressed) at baseline went down to only mild to minimal depressed after the program.
  • The VMR group’s overall symptom burden decreased by almost 50%!

Although we were pleased to see these results, we also wanted to see how the two groups compared against each other. In our second statistical model, we compared the two groups against each other instead of against themselves in isolation. One way to think about this type of statistical model is trying to see how you performed on a test compared to your best friend, Kyle.

When we compared the groups against each other, again we saw significant differences between the two groups in quality of life, depression symptoms, and overall symptom burden.

  • The VMR group had an improved quality of life; largely in how they perceived their mental health and vitality.
  • Although the results did not reach statistical significance, we found that when compared to the control group, the VMR group noted clinically significant improvements in perceived pain.
  • There were statistically and clinically significant decreases in depressive symptoms and overall symptom burden for the VMR group as compared to the wait list control group.

Take a look at some of the figures below that help to demonstrate these remarkable findings!

Figure Legend

  • PHQ-9 - Measurement of Depressive Symptoms
  • MSQ - Measurement of Total Symptom Burden


So What Does This All Mean?

We found that it’s certainly possible to improve health and depressive symptoms in people with major depression using lifestyle therapies whether or not someone uses a medication or not. As we noted in the introduction of this article, while we do not know exactly what component of the program actually made the most significant contribution to the positive results, it is very likely that a combination of everything helped participants improve their health. In addition, we strongly suspect that the online community played a pivotal role in supporting participants to make challenging lifestyle changes.

Study Limitations

While the study’s findings are indeed remarkable, it is also important to critically evaluate the limitations of our research. Because we only wanted to know the impact of the full completion of the study, our statistical analysis was limited to those who completed questionnaires at the beginning and end of the study. Unfortunately, 30% of people in the VMR group and 21% of people in the waitlist group were unable to complete all of their questionnaires, resulting in quite a bit of missing data. Why this happened, we aren’t entirely sure, however, this is not something unique to our study as participants in research frequently develop “questionnaire fatigue” when filling out numerous forms, and as a result, simply don’t do them. 

Additionally, because we recruited most of our participants from social media platforms, there may have been a bit of selection bias in those participating in the study. Meaning, that people who enrolled into the study wanted to be part of the study as they were already familiar with or showed interest in the VMR program and Dr. Brogan’s work. While this could make our results less applicable to people who have never heard of Dr. Brogan or have no experience with making significant lifestyle changes, we recognize that the evaluation of any lifestyle intervention requires motivated individuals with internal incentives rather than individuals who do not believe in the benefit of the studied intervention or by individuals who are motivated by an external financial reward alone.

Conclusions

Overall, we were able to find significant improvements in depressive symptoms and total symptom burden following the implementation of a multi-modal, online lifestyle medicine program compared to regular care. We challenge healthcare providers to stop arguing that lifestyle medicine cannot be easily provided, especially during the current state of our world, as this study was conducted entirely through an easily accessible, online platform with minimal physician involvement or a reliance on a significant amount of resources. As we look to the future, this study and the VMR program as a whole illustrate what is truly possible when we move from paternalistic, doctor driven therapies to therapies orchestrated by individuals themselves within supportive communities.

For those of you interested to read our peer-reviewed study findings in the journal Cureus, you can use the link at the end of the article to access the study and even download the study PDF. 

While sharing these study results within our community is a wonderful first start, we need your help to spread its message as far as possible, sharing with both friends and medical professionals who may not share your personal views. We cannot simply keep this in our own shared communities.

Science can sometimes seem like the enemy, with many individuals wielding “hammers” seeking to destroy curious inquiry at every opportunity. Science, however, can be a beautiful tool when applied to questions and ideas that really matter. I hope this story of how a community of individuals, just like you, came together for the sake of scientific inquiry inspires you to take the next step in your own journey of health as we all share our gifts for the collective healing of our world.

Read and Share the Study

Read the Study

About the Primary Investigator

Rob Abbott, M.D. is the medical director for Resilient Roots: Functional and Evolutionary Medicine in Charlottesville, Virginia. He completed his internship at the Shenandoah Valley Family Medicine Residency Program in Front Royal, Virginia and is a graduate of the University of Virginia (U.Va.) School of Medicine. He has completed training in functional medicine through the Kresser Institute and the Institute for Functional Medicine (IFM). He is the medical advisor for Autoimmune Wellness where he conducts lifestyle medicine research and writes articles for those with autoimmune disease. In his free time, Dr. Abbott enjoys trail running and creative expression through writing and communal conversation. He has a collection of writings including blogs, poetry and podcasts at his website A Medicinal Mind.

Study Team

Kyle Sherwin

Osteopathic Medicine, Midwestern University - Arizona College of Osteopathic Medicine, Glendale, Arizona

Hannah Klopf

Osteopathic Medicine, Rocky Vista University College of Osteopathic Medicine, Denver, Colorado 

Holly J. Mattingly

Counseling & Human Development, Lindsey Wilson College, Columbia, Kentucky

Interested in a comprehensive, drug-free approach to healing anxiety, depression or chronic stress?

The Vital Mind Reset program walks you through my 44-day healing protocol, which combines diet, detox, and meditation practices for long-term resolution of chronic symptoms. The tools implemented also help to establish a readiness for psychiatric medication tapers. Click below to learn more.

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About Dr. Kelly Brogan

KELLY BROGAN, MD, is a holistic psychiatrist, author of the New York Times Bestselling book, A Mind of Your OwnOwn Your Self, the children’s book, A Time For Rain, and co-editor of the landmark textbook Integrative Therapies for Depression. She is the founder of the online healing program Vital Mind Reset, and the membership community, Vital Life Project. She completed her psychiatric training and fellowship at NYU Medical Center after graduating from Cornell University Medical College, and has a B.S. from M.I.T. in Systems Neuroscience. She is specialized in a root-cause resolution approach to psychiatric syndromes and symptoms. Learn More