Andy
Retired committee member
Detailed Description:
Functional disorders are a challenging group of conditions treated both in primary and secondary care. Recently, mounting evidence shows that central nervous system sensitization is one of the involved mechanisms, giving new treatment opportunities. There are self-management programs and internet therapies that aim at overcoming the central sensitization by creating new neural networks in the brain. This study aims to test whether an Amygdala and insula retraining (AIR) program compared to an internet therapy developed at HUS (Helsinki University Hospital) and treatment as usual (TAU) is effective in the treatment of functional disorders, fibromyalgia, long Covid, and chronic fatigue syndrome (ME/CFS).
We will perform a multi-center randomized controlled trial in volunteering health units and with volunteering patients aiming at 360 patients altogether. The physicians in charge of the patients will be recruited from the Network for Functional Disorders launched by the novel clinic at HUS. The participating centers will receive an introduction in functional disorders, the underlying mechanisms, and treatment opportunities.
For functional disorders, this study applies the ICD-11 primary care code of Bodily stress syndromes (BSS), which covers fibromyalgia, irritable bowel syndrome, multiple chemical sensitivities, and other, both single system and multiorgan functional disorders. In addition, for patients with fibromyalgia, chronic fatigue symptoms, and long Covid, we will apply specific diagnostic criteria. Both primary and secondary care treatment units that manage these disorders can recruit patients.
The studied interventions are a mindfulness-based Amygdala and insula retraining (AIR) program and an internet therapy developed at HUS, and patients receive usual care in addition to these interventions. The third study arm consists of treatment as usual for six months after which the patients receive the AIR program or the internet therapy if they so wish. When the participating physicians consider that a patient could benefit from a self-management program, they introduce the trial to the patient. The consenting patient fills in a baseline survey and is followed up at 3, 6, and 12 months with the help of the HUSeCRF (online surveys at the HUS electronic Case Report Form), or research nurse's interviews.
This study will give new insight into the opportunities of self-management programs in the treatment of bodily stress syndromes, fibromyalgia, long Covid, and ME/CFS. We will find out whether the training programs increase patients' functional ability and quality of life as measured on a scale from 0 to 10. These scales and functional ability as measured by WHODAS 2.0 serve as main outcome measures for this study. This trial is the first large-scale randomized trial that assesses these methods developed to overcome the central sensitization of brain. The results will have an impact on the management of these common and often debilitating conditions.
https://clinicaltrials.gov/ct2/show/NCT05212467
Functional disorders are a challenging group of conditions treated both in primary and secondary care. Recently, mounting evidence shows that central nervous system sensitization is one of the involved mechanisms, giving new treatment opportunities. There are self-management programs and internet therapies that aim at overcoming the central sensitization by creating new neural networks in the brain. This study aims to test whether an Amygdala and insula retraining (AIR) program compared to an internet therapy developed at HUS (Helsinki University Hospital) and treatment as usual (TAU) is effective in the treatment of functional disorders, fibromyalgia, long Covid, and chronic fatigue syndrome (ME/CFS).
We will perform a multi-center randomized controlled trial in volunteering health units and with volunteering patients aiming at 360 patients altogether. The physicians in charge of the patients will be recruited from the Network for Functional Disorders launched by the novel clinic at HUS. The participating centers will receive an introduction in functional disorders, the underlying mechanisms, and treatment opportunities.
For functional disorders, this study applies the ICD-11 primary care code of Bodily stress syndromes (BSS), which covers fibromyalgia, irritable bowel syndrome, multiple chemical sensitivities, and other, both single system and multiorgan functional disorders. In addition, for patients with fibromyalgia, chronic fatigue symptoms, and long Covid, we will apply specific diagnostic criteria. Both primary and secondary care treatment units that manage these disorders can recruit patients.
The studied interventions are a mindfulness-based Amygdala and insula retraining (AIR) program and an internet therapy developed at HUS, and patients receive usual care in addition to these interventions. The third study arm consists of treatment as usual for six months after which the patients receive the AIR program or the internet therapy if they so wish. When the participating physicians consider that a patient could benefit from a self-management program, they introduce the trial to the patient. The consenting patient fills in a baseline survey and is followed up at 3, 6, and 12 months with the help of the HUSeCRF (online surveys at the HUS electronic Case Report Form), or research nurse's interviews.
This study will give new insight into the opportunities of self-management programs in the treatment of bodily stress syndromes, fibromyalgia, long Covid, and ME/CFS. We will find out whether the training programs increase patients' functional ability and quality of life as measured on a scale from 0 to 10. These scales and functional ability as measured by WHODAS 2.0 serve as main outcome measures for this study. This trial is the first large-scale randomized trial that assesses these methods developed to overcome the central sensitization of brain. The results will have an impact on the management of these common and often debilitating conditions.
https://clinicaltrials.gov/ct2/show/NCT05212467
