Three researchers from the Brain and Mind Centre’s multiple sclerosis research group are spearheading an innovative clinical trial that is changing the way chronic disease is managed and how studies are funded.
COMBAT MS is the first program in the world to integrate psychological strategies that target both ‘thinking skills’ and general psychological wellbeing in multiple sclerosis.
“There are a lot of pharma trials that treat the physical effects of the disease,” says Dr Keri Diamond, who is leading the trial with Professor of Neurology, Michael Barnett, as well as neuropsychology registrar Caitlin Dawes. “We’re trying to manage the psychological and social costs which are equally important,” says Keri.
As a neuropsychologist, Keri has worked in brain training for more than a decade to help slow down cognitive impairment in dementia patients. While working with Professor Barnett in his multiple sclerosis clinic, she saw people struggling to maintain meaningful roles in their lives.
“This is a population that typically get diagnosed with MS between the ages of 20 and 40. This is the prime of people’s lives – when they are studying, working, having children. There is little support out there for them. So what sometimes ends up happening is they withdraw from activities, they stop working and stop seeing friends, when in actual fact this doesn’t have to be the case.”
Keri strongly believes that, with the right support, people with MS can live active, social and engaging lives.
You can teach people to adjust to the disease. They may not be able to function the way they were functioning before, but they can still function pretty well and derive meaning from their lives.
COMBAT MS is also at the forefront of a new model for funding clinical trials. Even though the study doesn’t involve any medication, Novartis, a pharmaceutical company, is providing funding. “For a pharmaceutical company to be funding a clinical trial that’s not investigating their drug is a big step forward, and part of a paradigm shift taking place in the approach to managing chronic disease,” says Caitlin.
Traditionally, doctors, neurologists and pharmaceutical companies have subscribed to a medical model that focuses on treating and managing the cause of disease and physical symptoms. However, there is now a shift towards a more holistic approach. Professor Barnett and Novartis recognise this shift and their collaboration is testament to this.
“The health community is starting to take a more bio-psycho-social approach because, while drugs are helpful in treating the neuropathology, they’re not helpful in managing the patient more broadly – treating factors that contribute to their mood, worries, anxiety, stress, relationships and general coping,” says Keri.
For a pharmaceutical company to be funding a clinical trial that’s not investigating their drug is a big step forward, and part of a paradigm shift taking place in the approach to managing chronic disease
The program runs in a group format, each of which meet for 2.5 hours per week over 10 weeks. Keri and Caitlin teach participants evidence-based skills to help them adjust to their condition - socially and emotionally.
The first half of the program draws upon Cognitive Behavioural Therapy techniques where participants learn how to identify and improve unhelpful ways of thinking and behaving. Collaboration is key and each session adapts to meet the specific needs of members of each group.
The second half of the program teaches participants strategies to improve cognitive difficulties such as problems with attention and memory. They also use computer-based brain training to help strengthen areas of weakness.
“It became very clear that [the program’s] approach would present us with a refined set of coping skills; skills that would allow us to navigate the changing landscape that is MS,” said one research volunteer.
What’s more, the program is supportive in that it fosters a sense of community and provides participants with the opportunity to discuss their experiences with others. “This is the first time some of our participants have been able to spend time with other people with MS," says Caitlin. "They’re able to share their experiences and have that social support within the group itself. Many of our participants continue to meet even after the groups have finished.”
It became very clear that the program’s approach would present us with a refined set of coping skills; skills that would allow us to navigate the changing landscape that is MS
Keri, Michael and Caitlin hope this program will lay the foundations for a new, cost-effective model that is accessible to the wider community. “This has been created to not only apply to MS but potentially apply to a whole range of chronic health conditions,” says Keri. If other industry partners like Novartis see the benefit of investing in non-pharma trials, this promising possibility may not be far off.