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Yes, Clinical Trials Are For Mental Health Too

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According to the National Institute of Mental Health (NIMH), post-traumatic stress disorder (PTSD) can occur after experiencing a traumatic event, such as childhood abuse, assault or a violent crime, military combat, or a natural disaster. It’s estimated that about 7-8% of the U.S. population will experience PTSD in their lives. 

• What is PTSD?

Given how many people experience PTSD, research and clinical trials can play a key role in advancing PTSD knowledge and treatment, not unlike other conditions such as cancer. However, there are often more roadblocks when it comes to mental health and clinical trials, particularly as it relates to getting people enrolled. Understanding what’s involved in a clinical trial can help demystify the process for those who might be interested in participating. 

The Mighty caught up with Rachel Yehuda, Ph.D., to get her take on clinical trials and the treatment of PTSD. Dr. Yehuda is a professor of psychiatry and neuroscience and the director of the Center of Psychedelic Psychotherapy and Trauma Research at Mount Sinai in New York.

Here’s what she had to say:

How can clinical research help find solutions to the challenges associated with PTSD and mental health?

Yehuda: Research helps us evaluate whether a treatment approach will work, and sometimes new treatments are only available through research. But these days, when you enroll in a treatment trial, you may also be asked to provide a blood sample or undergo brain imaging, and this is done to increase our knowledge of who may benefit from which approach.  Scientists have made tremendous advances in cancer treatments, which are sometimes called “personalized medicine.” This type of medicine uses genetic information to take the very best guess at which of many treatments will work for one patient. Many trials now also take into account things like blood samples and brain images. But what does this have to do with treatment outcome? It helps us understand which particular person might benefit from a treatment, based on their individual makeup. 

How does clinical research help better understand mental health conditions and help find new avenues for treatment? 

Yehuda: Great question. Most people who have sought help from a mental health provider are put on medication or are offered either counseling or a specific type of psychotherapy. After that, people are usually told to wait; give the treatment a chance to work. And in both cases, you might feel worse before you feel better. Then the patient and provider could get anxious about the fact that change isn’t happening fast enough, which might lead to a change in treatment instead of waiting it out. On the other hand, the treatment just might not work at all. This can make patients think it’s a constant trial and error. Even if a provider knows some things about handling PTSD, navigating treatments can feel frustrating for a mental health condition. 

There are great debates in mental health about what kind of approaches to use. Research is how we resolve those debates and are able to have intellectual discussions. It can’t be a philosophical discussion, it has to be based on empirical data. The more empirical data that we generate, the more knowledge that we will generate, and the less trial and error there will be. We will give more hope to people and less false starts. 

Are clinical trials always studying something new? Do they ever review something that’s already been done? 

Yehuda: Funding agencies want to fund novel research, so if something has been absolutely asked and answered, there’s no point in redoing it too many times. However,  if the answers have been different or all over the place, then you’d look at the design of the study and then say, “OK, well, the reason that we haven’t gotten consistent results is because there are some design flaws. Let’s try it again but really do it right.” So it’s possible to have clinical trials that are similar to what’s been done in the past, but you tweak it to resolve those past discrepancies. 

Sometimes there will be trials that compare one known-to-work medicine with another to see if there’s a difference when you do a head-to-head comparison. Sometimes trials try psychotherapy with and without a medicine, or vice versa. As our knowledge advances to the next level, we want to build on the knowledge. If you’re signing up for a clinical trial, you’re not signing up for a path that has been very trodden in the past. No scientist wants to keep doing the same thing. 

However, sometimes very methodical science proceeds in baby steps; sometimes it’s a revolution. Sometimes you have a trial that says, throw out everything you know, we’re gonna do something new and revolutionary. When there’s a 20% reduction in symptoms, sometimes we want to know, well, how do we tweak it up to 30 or 40%? The consumer has to be very informed about a clinical trial.

Are there any ways in which clinical research for mental health conditions differ from clinical research for other health conditions? 

Dr. Yehuda: With cancer, people tend to jump at clinical trials, especially if the prognosis is bad. But with mental health, there’s the opposite reaction. People don’t want to feel like a “guinea pig.” Are you technically a “guinea pig”? Sure, because it’s research, but participant safety is always a top priority in a clinical trial. Obviously, there can always be adverse effects or side effects, and you’ll be heavily monitored. But usually in those circumstances, if you get randomized to a treatment, it’s either a placebo, or the treatment simply didn’t work for you. Clinical trials really give us the best possible way of bringing critical information to the field of mental health and PTSD and minimizing those trial and errors.

What do you feel is most misunderstood about PTSD and clinical trials? 

Yehuda: For many clinical trials, people who have a lot of complex mental health conditions aren’t eligible. Some of those trials really would require a very specific clinical presentation. And you should never feel badly if you’re not eligible. It doesn’t mean you don’t need treatment. It probably means that your symptoms are complex, so nobody wants to take a chance with addressing only one part of the symptoms you experience, while ignoring the others. 

What people should realize about clinical trials, particularly from academic medical institutions, is that the level of scrutiny and review is so intense, it feels completely protected. The amount of protection, research protocols, monitoring and checks, and balances is way greater than anybody would get in regular, standard clinical treatment. So there are a lot of benefits in participating in clinical research, and they’re often free! It might really afford somebody, particularly someone that doesn’t have a lot of money, to get the right treatment.

How do clinical trials help better support the maintenance of conditions like PTSD?

Yehuda: By the time someone signs up for mental health treatment, it’s not the first time they’ve ever not felt good; they may be very close to the bottom of the barrel and their ability to cope. The last thing they need is a setback, but people often don’t start early enough to get treatment. We normalize our struggles, right? It’s like the dentist: Instead of going for a cleaning, we go to fill a cavity. Or instead of filling a cavity, sometimes it’s a root canal that’s needed. If we don’t do the maintenance stuff, then a lot of the time you’re going in when it’s already a big problem. By the time it’s really bad, it’s also sometimes harder to treat. Trying to seek opportunities to participate in research might really increase your mental wellness. And it will really support the field of mental health and resilience in terms of understanding when people should come in for the most optimal kind of benefits.

If you’re interested in learning more about participating in a clinical trial, visit NIMH’s website.

Originally published: March 16, 2021
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