The Effectiveness of a Body-Affective Mindfulness Intervention for Multiple Sclerosis Patients with Depressive Symptoms: A Randomized Controlled Clinical Trial

Abstract

Purpose: Mindfulness interventions have been shown to treat depressive symptoms and improve quality of life in patients with several chronic diseases, including multiple sclerosis, but to date most evaluation of the effectiveness of mindfulness interventions in multiple sclerosis have used patients receiving standard care as the control group. Hence we decided to evaluate the effectiveness of a group-based body-affective mindfulness intervention by comparing it with a psycho-educational intervention, by means of a randomized controlled clinical trial. The outcome variables (i.e., depression, anxiety, perceived stress, illness perception, fatigue and quality of life) were evaluated at the end of the interventions (T1) and after a further 6 months (T2).Methods: Of 90 multiple sclerosis patients with depressive symptoms (Beck Depression Inventory-II score greater than 13) who were randomized, 71 completed the intervention (mindfulness group n = 36; psycho-educational group n = 35). The data were analyzed with GLM repeated-measures ANOVA followed by pairwise comparisons.Results: Per-protocol analysis revealed a time by group interaction on Beck Depression Inventory-II score, with the mindfulness intervention producing a greater reduction in score than the psycho-educational intervention, both at T1 and at T2. Furthermore, the mindfulness intervention improved patients’ quality of life and illness perception at T1 relative to the baseline and these improvements were maintained at the follow-up assessment (T2). Lastly, both interventions were similarly effective in reducing anxiety and perceived stress; these reductions were maintained at T2. A whole-sample intention-to-treat (ITT) analysis broadly confirmed the effectiveness of the mindfulness intervention.Conclusion: In conclusion, these results provide methodologically robust evidence that in multiple sclerosis patients with depressive symptoms mindfulness interventions improve symptoms of depression and anxiety and perceived stress, modulate illness representation and enhance quality of life and that the benefits are maintained for at least 6 months.Trial registration: the study was registered in the ClinicalTrials.gov registry (NCT02611401).

Mindfulness-based interventions for mental well-being among people with multiple sclerosis: a systematic review and meta-analysis of randomised controlled trials

“…Twelve RCTs were identified as eligible for inclusion in the systematic review. [21][22][23][24][25][26][27][28][29][30][31][32] However, only eight studies reported endpoint data that could be included in the meta-analysis. 21-24 28-30 32 (figure 1).…”

“…Overall effects for MBCT vs usual care came from a small study 28 (n=40), where SMD was 0.78 (0.45, 1.11), I 2 =0%. In another study 24 (n=90), compared with a psychoeducation control, body-affective mindfulness had an overall SMD of 0.24 (0.00-0.48), I 2 =0%. From the five studies 21 22 29 30 32 with extractable endpoint data that used MBSR (total n=449), overall SMD was 0.29 (0.15-0.42), I 2 =0%, three studies 22 29 30 comparing MBSR against usual care, two 21 32 against psychoeducation controls.…”

“…Five studies took place in Iran, 23 25-27 29 three in the UK, 22 28 31 two in Italy, 24 32 one each in Switzerland 30 and the USA. 21 Six studies reported assessing a MBI against usual care, 22 23 28-31 in three this was not specified, [22][23][24] while three used an active comparator (psychoeducation control). 21 24 32 Six studies were powered.…”

“…21 28 Eight studies reported session content, 21-23 25-29 three gave minimal description, [30][31][32] one referred to the study protocol. 24 Seven studies described home practices. 21-24 28 30 31 Seven studies reported teacher characteristics, 21-24 28-30 but in two detail was minimal.…”

Longitudinal Associations of Modifiable Lifestyle Factors With Positive Depression-Screen Over 2.5-Years in an International Cohort of People Living With Multiple Sclerosis

“…Exercise therapy for depression is increasingly common and effective in the general population ( 12 ), and has also shown promise for people with MS ( 13 ). Mindfulness-based interventions for people with MS have also been shown to improve depression and quality of life at 6 months follow-up ( 14 ).…”