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Mental Health Considerations in Clinical Research
May is “Mental Health Awareness Month” in the United States, marking a concerted nation-wide effort to raise the profile of dialogue about our emotional, psychological, and social well-being, with special emphasis on increasing awareness of struggling populations. Extending the conversation beyond an awareness month, mental health is a complex part of the clinical research landscape, and one we believe deserves more attention from a variety of angles.
Hope Biosciences Research Foundation (HBRF) is a non-profit clinical research organization that serves patients on-site, co-located with commercial manufacturing laboratories for an investigational adult cell therapy drug we often study. As such, we have nuanced insight into innumerable facets of mental health. No phase of research occurs in isolation here. Patients sit in our chairs, family members wait in our lobby, caregivers stay nearby, providers roam the halls, and scientists work down the hall. We have the privilege of learning from them all.
We are not mental health professionals, and do not propose solutions here. We hope that simply raising the conversational profile of each primary group of people we serve will spark the sort of thoughts that result in more effective study design, with corresponding development of increasingly refined quality-of-life measures. Clinical research as a sector needs better practices for articulating the way mental health can impact results. The U.S. Food and Drug Administration (FDA) values patient reports, for example, but how do we better account for, say, placebo and “nocebo” effects?[1] We also hope heightened sensitivity to the role of mental health in clinical research will allow us and other research organizations to create more comfortable spaces for research participants.
Categorized by population, this month we hope to raise awareness about mental health considerations in:
Clinical trial participants. HBRF has the privilege of conducting clinical research in a staggering array of conditions, serving patients ranging in age from 18 months to more than 90 years. What do they all have in common? Their diagnosed diseases or injuries are considered incurable. Their conditions are degenerative, on varying timetables. They are in physical discomfort, often pain. If they are old enough to identify and articulate their emotions, they are often facing fears surrounding disability and/or death. By the time we meet them, they are usually experiencing profound impacts on quality of life, and may already be utilizing mobility aids, or withdrawing from activities and lifestyle rhythms that previously brought them joy. Nearly all our participants have had negative experiences with medical practitioners and conventional medical care; those same experiences can be what drives them to seek out clinical research opportunities. Taken together, physical discomfort, perceived lack of hope, and ill treatment by others can give rise to moral, spiritual, or religious questions with potential to further stress and isolate the suffering individual.
FDA-authorized clinical trial protocols often preclude individuals with diagnosed mental health conditions from participation, unless the study is in a mental health or psychological condition. Participants may not be in diagnosable crisis, but their mental health journey can be dramatic, and mental health state can impact clinical outcomes.[2] Not directly related to their clinical trials or medical conditions, protocols often dictate a year-long study period, or even longer. A lot of life can happen in a year, or two, or three. People lose loved ones, suffer job changes, confront financial insecurity, and all the other stressors anyone else faces, each of which carry potential to overwhelm.
The patient’s community (or lack thereof). Houston is a sociocultural melting pot, which matters to clinical research because the area’s demographic diversity allows previously unstudied populations to access clinical research opportunities, should they so desire. Some cultures, however, are more accepting of investigational medicine than others. Cultures can be more or less supportive of patients sharing their condition publicly, or of voicing their candid experience even to clinical staff. Though adult cell therapy is prohibited by no religion doctrine or cultural affinity, trial participants often face an education curve in their own social circles. Whether they choose to disclose or not, patients commonly report perceived feelings of being misunderstood by or isolated from their sociocultural communities as a result of participation in clinical research.
Enhanced and refined understanding of sociocultural considerations that affect participation in clinical research may allow for development of better study recruitment practices, dramatically widening the scope of participants to previously underserved populations. HBRF, which extends treatment free of charge to research participants, takes this charge seriously. Click here to read more about why we believe allogeneic cell therapy is the future of accessible regenerative medicine.
Families and caregivers. The diseases studied at HBRF are chronic and degenerative, which means they give rise to the fears and anxieties associated with watching a loved one endure what is often prolonged decline. There is likely a genetic component to many of the conditions HBRF studies, which means individual family members may themselves be battling fears or health crises. Sometimes, family members are also primary caregivers to individuals requiring significant assistance. In these cases, inner turmoil can be further complicated by sustained fatigue.
Emotions may be particularly heightened in cases where families are watching a loved one experience cognitive decline, or pronounced changes in ability to communicate, move, or live independently. There are any number of condition-specific support groups in the greater Houston area, and HBRF actively refers patients and their families to organizations we know and trust. The bottom line remains, however, that the journey is rife with mental health considerations.
Our team. We experience many of the same emotions present in any healthcare setting, including but not limited to fatigue, operational stress, frustration at regulatory bodies who block access to promising technologies for patients we love, and disillusionment at conducting double blind studies (in studies of this design, some patients receive the drug and some placebo. We love them all, and want them all to receive treatment.) Members of our team may need to work through profound questions about justice and humanity, as we watch beautiful people confront horrific physical circumstances. There can be moments of personal anger and disillusionment, as we choose which trials to execute and which to postpone until more funding is secured. In the wait, patients can pass away. That has happened at HBRF, and a plaque on the door to our “Mission Control” room reminds us, every day, why we must work faster. (Click here to meet and learn more about Paxton Bernal and the Paxton Bernal Mission Control room.)
The HBRF team is comprised of seasoned clinical professionals, many of whom have extensive experience in hospital or other healthcare settings and have over time developed their own coping mechanisms. Others are new and must be mentored, including how to safeguard their own mental health. There is no perfect solution, but we lean on each other, have clear lines of communication to leadership, celebrate the victories, and insist everyone take their vacation and time away. We are quick to refer out to professional mental care not only for job-specific stressors, but for expected life hardships such as births and deaths, changed personal health circumstances, family events, and others.
In sum
Looking at the wide array of mental heath considerations of which HBRF is aware in the clinical research landscape, in our field, and in the people we directly serve can create a feeling of overwhelm. Our strategy is straightforward. Each of the populations previously presented struggles against feelings of hopelessness and related mental health concerns associated with mental, emotional, and even spiritual fatigue, depression, anxiety, and more. Our response, then, is to consistently and unblinkingly deliver exactly what our name says we do — Hope, billions of stem cells, one dozen team members, and one personal encounter at a time.
[1] Tu, Y., Zhang, L. & Kong, J. Placebo and nocebo effects: from observation to harnessing and clinical application. Transl Psychiatry 12, 524 (2022). https://doi.org/10.1038/s41398-022-02293-2
[2] Sang D, Xiao B, Rong T, Wu B, Cui W, Zhang J, Zhang Y, Liu B. Depression and anxiety in cervical degenerative disc disease: Who are susceptible? Front Public Health. 2023 Jan 6;10:1002837. doi: 10.3389/fpubh.2022.1002837. PMID: 36684946; PMCID: PMC9853204.
