Background Mindfulness-based stress reduction is an efficacious treatment for people with chronic health problems; however, it is highly intensive and time-consuming, which is a barrier for service provision. Objective This study aims to develop an internet-delivered adapted version of mindfulness-based stress reduction for people with multiple sclerosis to make the intervention more accessible. Methods We co-designed a web-based mindfulness program with end users, that is, people with multiple sclerosis (N=19). Iterative feedback was also collected from a subsample of the initial group of end users (n=11), and the program was reviewed by experts (n=8). Results We identified three main themes common to people with multiple sclerosis: dealing with uncertainty and fears for the future, grief and loss, and social isolation. These themes were incorporated into narratives throughout the program. People with multiple sclerosis who reviewed the program gave feedback that the program was relatable, feasible, and acceptable. Experts agreed that the program appropriately represented the main tenets of mindfulness. Iterative feedback was used to further refine the program. Conclusions The web-based mindfulness program that we developed was viewed positively by both experts and end users. The program reflects common concerns for people with multiple sclerosis and has the potential to meet important unmet psychological needs. A randomized controlled trial was planned to determine the efficacy of the program.
Background: Psychosocial interventions are often used as an adjunct to the medical management of multiple sclerosis (MS). However, the efficacy of such approaches for a range of psychosocial indications remains unclear. Objective: To determine the efficacy of psychosocial therapies for people with MS (PwMS). Methods: We searched 6 electronic databases (Medline, Embase, PsycINFO, Cochrane Central Register of Controlled Trials, CINAHL, and Clinicaltrials.gov) until April 21, 2016, for randomized controlled trials reporting the effect of psychological interventions for depressive symptoms, anxiety, pain, fatigue, or health-related quality of life (HRQoL) in PwMS. Results: The search yielded 356 articles with 13 included studies (n = 1,617). Benefits of psychological interventions were found for depressive symptoms (Cohen’s d = 0.281), anxiety (d = 0.285), fatigue (d = 0.228), and mental (d = 0.398) and total HRQoL (d = 0.444), but not physical HRQoL. There were insufficient studies to meta-analyze posttreatment outcomes for pain. Interventions were more effective for HRQoL for patients with relapsing-remitting MS and when treatment doses were larger. Cognitive behavioral therapy (CBT) was not efficacious for PwMS when considered alone. Conclusion: Psychosocial interventions have a significant, positive impact across a range of outcomes for PwMS with small, yet consistent, effect sizes. There was some indication that CBT was less efficacious than other interventions. However, this may be due to smaller treatment doses in CBT studies.
Background: Evidence shows small positive effects associated with psychological treatments for people with multiple sclerosis (PwMS). In a recent meta-analysis, the treatment with the largest effect size was a mindfulness-based intervention (MBI). Objectives: We aimed to determine whether an Internet-delivered MBI was beneficial for PwMS. Furthermore, we aimed to investigate history of recurrent depression as a moderator of treatment outcome. Methods: Participants ( N = 132) were assessed based on whether they had a history of recurrent depression, then stratified and randomized to MBI or waitlist. Outcomes were assessed at baseline, post-intervention, and 3 and 6 months. Results: The MBI group reported significantly improved depressive symptoms (primary outcome) compared with the waitlist ( p = 0.046, Cohen’s d = 0.39). Those with a history of recurrent depression benefitted significantly more than those without ( p = 0.034, d = 0.66). There were benefits for health-related quality of life (HRQoL) in the MBI, irrespective of depression history ( p = 0.009, d = 0.5). Pain interference was less overall in the MBI group ( p < 0.001, d = 0.2), but change over time did not differ from waitlist. There were no treatment effects for anxiety, pain severity or fatigue. Conclusion: The Internet-delivered MBI significantly improved depressive symptoms and HRQoL in PwMS. For depression, the benefits were greater for those with a history of recurrent depression. Trial Registration: ACTRN12618001260213, available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375598
Background 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. 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/design This 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. Discussion Multiple 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 registration ACTRN12618001260213 . Date of Registration: 25/07/2018. Electronic supplementary material The online version of this article (10.1186/s12883-019-1356-9) contains supplementary material, which is available to authorized users.
IntroductionPsychosocial treatments have been shown to benefit people with rheumatoid arthritis (RA) on various outcomes. Two evidence-based interventions are cognitive behavioural therapy (CBT) and mindfulness-based stress reduction (MBSR). However, these interventions have been compared only once. Results showed that CBT outperformed MBSR on some outcomes, but MBSR was more effective for people with RA with a history of recurrent depression, with efficacy being moderated by history of depressive episodes. However, this was a post-hoc finding based on a small subsample. We aim to examine whether a history of recurrent depression will moderate the relative efficacy of these treatments when delivered online.Methods and analysisThis study is a randomised controlled trial comparing CBT and MBSR delivered online with a waitlist control condition. History of recurrent depressive episodes will be assessed at baseline. The primary outcome will be pain interference. Secondary outcomes will include pain intensity, RA symptoms, depressive symptoms and anxiety symptoms. Outcome measures will be administered at baseline, post-treatment and at 6 months follow-up. We aim to recruit 300 participants, and an intention-to-treat analysis will be used. Linear mixed models will be used, with baseline levels of treatment outcomes as the covariate, and group and depressive status as fixed factors. The results will demonstrate whether online CBT and MBSR effectively improve outcomes among people with RA. Importantly, this trial will determine whether one intervention is more efficacious, and whether prior history of depression moderates this effect.Ethics and disseminationThe trial has been approved by the Human Research Ethics Committee of the University of Sydney (2021/516). The findings will be subject to publication irrespective of the final results of the study, and based on the outcomes presented in this protocol.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12621000997853p).
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