As the world enters year three of the Covid-19 pandemic, it has become increasingly apparent that the psychological toll of countrywide lockdowns and paused access to mental health care have resulted in rising cases of eating disorders. In fact, forecasts show that binge-eating disorder diagnosis will likely increase and surpass current forecast estimates over the next five years, according to GlobalData epidemiologists.
Questions remain about what this increase in diagnosis rates means for clinical trials conducted in the past two years, and if the forecast growth in the pool of people to recruit from will allow for quicker clinical trial recruitment in the future. We investigate the issue further, speaking to several experts in eating disorders.
More people seeking help for eating disorders
During the pandemic, vulnerable people were exposed to an overload of health and fitness content on social media, which triggered many into the downward spiral of eating disorders, explains Tracey Wade, PhD, dean of the School of Psychology at Flinders University in South Australia. People who were already diagnosed experienced worsening symptoms, such as restrictive eating or excessive exercising, adds Kamryn Eddy, PhD, associate professor of psychology at Massachusetts General Hospital.
Still, compared to those diagnosed prior to the pandemic, newly diagnosed people seem to not have as severe symptoms, Eddy says. With stay-at-home measures, people who live with those with potential food issues can raise concerns of someone’s risk of an eating disorder, which may lead to greater, earlier help-seeking, she explains.
Recruitment challenges remain
Despite an increased number of diagnoses, already diagnosed people having increased eating disorder events, and more people being interested in seeking treatment, recruitment for eating disorder clinical trials was not made any easier, Eddy says.
While there might be an increase in people with eating disorders, they might not be the type of participants that clinical trials are after. Wade notes there has been an increase in other specified feeding and eating disorders (OSFED). These are people with eating disorders who do not meet the diagnostic criteria for anorexia nervosa, restrictive food intake, binge eating, or bulimia nervosa. People with OSFED have significant weight loss, are starving, and are medically and mentally unstable, she explains.
It is important to focus on the first signs of eating disorders, such as starvation, instead of waiting for the patient to lose enough weight for it to be considered an eating disorder, notes Dr Peter Asellus, associate professor in psychiatry at Umeå University in Sweden. However, finding such trial participants for treatments is challenging. People who show signs of starvation can have a normal weight, but they will only receive treatment when they meet the diagnostic criteria for anorexia nervosa, he added.
According to the GlobalData clinical trials database, a significant number of eating disorder drug clinical trials that are recruiting or are recruiting by invitation are in anorexia nervosa. This is followed by appetite-eating disorders, binge-eating disorder, and bulimia nervosa.
Pandemic fatigue, lockdowns barrier in clinical trials
Pandemic fatigue is also playing a part in obstructing recruitment. Wade conducted an investigator-led clinical trial in Australia studying online-based family therapy for adolescents with anorexia nervosa. The aim was to offer help and support while waiting for in-person treatment, which can take up to eight months. The recruitment was expected to be straightforward, but only 20% of eligible candidates for the trial participated, she notes.
Similar trials are happening the US and Canada, and they are also facing recruitment issues, Wade adds. Researchers in Sweden also faced difficulties in recruiting patients, Asellus notes.
An overload of remote education or work can make some people too overwhelmed to join online treatments, Wade explains. There may be a surge in clinical trial engagement once the pandemic shows signs of easing, she says. “When people are feeling a little bit less like they are walking through mud just to get through their daily lives, maybe then they will have that energy and resilience to engage with therapy,” she notes. Notably, this is occurring in Australia, where Clinical Trials Arena previously reported that the country’s “zero-Covid” plan has generally protected its clinical trials activity.
Furthermore, lockdowns made engagement among clinical trial sites more challenging. Eddy notes, from her experience in running clinical trials, a good part of its recruitment is that they engage with treatment centers with a high level of care for people with eating disorders. Partnerships with such facilities help find potential participants for clinical trials. However, it is harder to engage with these facilities due to pandemic restrictions, she adds.
Still, there are solutions. To combat recruitment issues, Wade explains that instead of collecting data at the end of the clinical trial or during periodic follow-ups, weekly measurements can help. More data gathering allows researchers to have enough observations to make an analysis, she adds. Clinical Trials Arena has been following the rise of decentralised clinical trials over the past few months, noting that such an approach does not only cover virtual elements, but also in-person approaches.
Challenging recruitment even before the pandemic
These new challenges are occurring in addition to pre-existing recruitment obstacles. Some people with an eating disorder have hard time getting rid of their own ambivalent feelings towards their illness, Wade says. For example, people with anorexia nervosa might feel the pressure to keep their thinness, which has high societal value in modern culture, she explains.
Keeping people with eating disorders in treatment can be a challenge as they are being asked to do activities they have been avoiding, such as having a healthy and balanced diet or participation in physical activity, Wade adds. This can make it harder for people to seek the care and treatments they need, she notes.
The attraction behind participating in clinical trials is that people can access committed care, Eddy says. Asellus adds that patients who are already in hospitals receiving eating disorder treatment are more at risk of serious health consequences if they get Covid-19. This motivates them to follow the treatment protocol to get better, he notes.
Ongoing trials mostly in anorexia nervosa
There are at least 59 ongoing eating disorder clinical trials worldwide that are recruiting, with most of them in anorexia nervosa. This may be due to the fact that there is a significant unmet need in this space, says Eddy, adding this eating disorder has the highest premature mortality risk.
There is also a dearth of evidence-based medication. People with anorexia nervosa receive psychological treatments, such as family-based treatments for adolescents and cognitive behavior therapy for adults, and fewer than half of them will achieve recovery.
Another trend among the 59 clinical trials is that a large percentage of these studies are investigator-led, with only Pfizer being the most recognisable pharma company with ongoing trials in this space. Wade notes there is the perception that eating disorders are not profitable, despite the fact that they have high unmet need. Pfizer did not respond to a comment request.
With many countries strategically easing their lockdown restrictions, pandemic-induced recruitment challenges may also ease. “I do hope that 2020 was an outlier in terms of increase of eating disorder diagnosis rates due to the global shutdown having a high mental health cost, specifically in younger people and people who have an eating disorder,” Eddy notes. Still, one thing is certain: the past two years has put an even more intense spotlight on the importance of addressing eating disorders.
Additional reporting by Reynald Castañeda