Abstract
BackgroundMultiple sclerosis (MS) is a neurological disease of the central nervous system and is associated with many psychosocial symptoms that are difficult to manage including low mood, anxiety, fatigue and pain, as well as low health-related quality of life. Internet-based psychosocial interventions that use mindfulness-based approaches are gathering much attention in recent literature, particularly in the treatment of chronic illnesses. However, no large randomized controlled trials have been done examining the efficacy of such interventions for people with MS (PwMS).Methods/designThis study is a randomised controlled trial of an online mindfulness-based intervention (MBI) for PwMS. Participants will be randomised to receive either the MBI or offered the intervention after a waiting period. All participants will be assessed to determine whether they have a history of recurrent depressive disorder. The primary outcome will be severity of depression, according to the Centre of Epidemiology Depression Scale. Secondary outcomes will be anxiety severity, fatigue, pain and quality of life. Assessments will be conducted pre, post-treatment, at three and six-month follow-up. The online mindfulness-based program was developed in collaboration with end-users (n = 19 PwMS) who gave feedback about what would be feasible and acceptable, and the draft program was reviewed by both experts and patients.DiscussionMultiple sclerosis is the most common acquired chronic neurological disease amongst young adults and is associated with a range of symptoms that can be difficult to cope with. In face-to-face interventions, a MBI demonstrated the largest effect in a recent meta-analysis of psychological treatments for PwMS, but MBIs for PwMS have not been delivered online. Hence, this trial will confirm whether MBIs can be efficacious when delivered online. A range of symptoms are assessed as outcomes so that the nature of benefits associated with the online MBI can be ascertained.Trial registrationACTRN12618001260213.Date of Registration: 25/07/2018.
Highlights
Multiple sclerosis (MS) is a neurological disease of the central nervous system and is associated with many psychosocial symptoms that are difficult to manage including low mood, anxiety, fatigue and pain, as well as low health-related quality of life
Aims and hypotheses The aim of the current study is to evaluate the efficacy of an online mindfulness-based program for symptoms of depression, anxiety, fatigue, pain and health-related quality of life in people with MS (PwMS)
Given the unpredictable nature of the disease, psychological interventions targeted towards reducing symptoms of depression, anxiety, fatigue and pain may help to alleviate emotional distress associated with the possibility of increasing disability and optimise quality of life
Summary
Multiple sclerosis (MS) is a neurological disease of the central nervous system and is associated with many psychosocial symptoms that are difficult to manage including low mood, anxiety, fatigue and pain, as well as low health-related quality of life. People with MS (PwMS) have a range of psychosocial consequences and symptoms associated with the illness that compromise their quality of life These include depression, anxiety, fatigue and pain. Meta-analyses found that CBT is effective for improving mood [3,4,5], fatigue [6], and healthrelated quality of life (HRQoL) [7] in PwMS These meta-analyses included relatively few studies, most with small sample sizes (e.g. n < 20 per study arm) which may over-estimate treatment efficacy [8]. A more recent, comprehensive meta-analysis examined the efficacy of psychosocial interventions for PwMS [9] and found that CBT was not effective in improving anxiety, depression, fatigue or HRQoL in PwMS, when considered in isolation, in contrast to other interventions
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