<p>The Effectiveness of Occupational Therapy-Based Sleep Interventions on Quality of Life and Fatigue in Patients with Multiple Sclerosis: A Pilot Randomized Clinical Trial Study</p>

Abstract

Purpose: Sleep difficulties are common in patients with multiple sclerosis (MS), which may increase feelings of fatigue, negatively interfere with daily activities, and consequently reduce their quality of life. Studies examining the effects of sleep-targeted interventions in MS are currently limited in the literature. Therefore, we aim to assess the effects of occupational therapy interventions on sleep quality, fatigue, and quality of life in patients with MS. Patients and Methods: In a single-blind, randomized, controlled trial, which occurred between April 2018 and March 2019 in Tehran, Iran, 20 eligible patients with MS were assessed using the Pittsburgh Sleep Quality Index (PSQI), Fatigue Impact Scale (FIS), Fatigue Severity Scale (FSS), and Short-Form Health Survey (SF-36). Patients were allocated randomly into the two following groups: patients receiving care-as-usual for MS (CAU) and patients receiving care-as-usual plus intervention (CAU + intervention). Both intervention groups underwent 2-3 sessions per week lasting 30-45 minutes for 8 weeks and received follow-up assessments. Data were analyzed using independent sample t-tests and Mann-Whitney U tests using SPSS (16 ver.) statistical software. Results: In the intervention group, sleep quality improved significantly across all items (p<0.001, effect size = 0.60) except for sleep efficiency and the use of sleep medications. FSS and FIS in the sleep intervention group were significantly reduced (p<0.001, effect size = 0.76 and p<0.001, effect size = 0.82, respectively). The quality of life in the intervention group improved significantly (p<0.004, effect size = 0.51-0.76) with the exception of the social functioning subgroup. Conclusion: Although this is the result of a pilot study and more patients should be added, this intervention program demonstrates improvement in sleep quality and quality of life while decreasing fatigue in patients with MS. Adjunction of this program, if results are similar with more patients, to routine occupational therapy (OT) interventions can help improve the rehabilitation program of MS patients.

Behavioral interventions to improve sleep outcomes in people with multiple sclerosis: A systematic review

“…Fifty one percent of the studies were conducted in North America (94% of which were in the United States), 29% in Europe, 23% in Asia, and 3% in Australia. The most prevalent study design was RCT (n=19 26-35 ; 54%; of which n=9 36-44 self-identified as being a pilot RCT) followed by single group pre-post design (n=11 45-55 ; 31%). Case reports (n=2 56,57 ; 6%), qualitative studies (n=2 58,59 ; 6%), quasi experimental studies (n=2 60,61 ; 6%), and case series (n=1 62 ; 3%), were also included.…”

“…50 Relapse-remitting MS constituted the majority of MS types for every study except for three studies. 39,51,57 Sleep was stated as the primary outcome in nine 26,27,32,36,41,43,45,46,50 of the 37 studies. The Pittsburg Sleep Quality Index (PSQI) was the most commonly used sleep outcome utilized in 19 26,29-31,35-39,41,42,44,48,50,53-55,57,60 of the studies followed by the Insomnia Severity Index (ISI) (n=10 32-34,37,39,42,44,45,56,62 ), actigraphy (n=5 37,38,43,46,60 ), and sleep log/diary data (n=5 38,43,46,56,57 ); six of the studies incorporated an objective measurement (actigraphy (n=5 38,43,46,56,57 ); EEG (n=1 45 )).…”

“…The Pittsburg Sleep Quality Index (PSQI) was the most commonly used sleep outcome utilized in 19 26,29-31,35-39,41,42,44,48,50,53-55,57,60 of the studies followed by the Insomnia Severity Index (ISI) (n=10 32-34,37,39,42,44,45,56,62 ), actigraphy (n=5 37,38,43,46,60 ), and sleep log/diary data (n=5 38,43,46,56,57 ); six of the studies incorporated an objective measurement (actigraphy (n=5 38,43,46,56,57 ); EEG (n=1 45 )). Interventions included physical activity (n=13 31-33,37-39,41,45,46,50,51,53,55 ), CBT-I (n=6 42-44,56,57,62 ), CBT/psychotherapy (n=4 26,27,30, ), mindfulness/relaxation (n=6 28,48,49,58-60 ), education and self-management support (n=3 29,36,54,61 ), and complementary and alternative interventions including acupuncture 47 , neurofeedback and hypnosis 64 , trauma releasing exercises 52 , foot reflexology 35 , integrated imaginative distention 34 (all n=1). Details regarding sample demographics, intervention provided, and the major sleep findings are summarized by intervention category in Table 2.…”

“…While there was no significant change in PSQI at program completion or at the 3-month follow-up in the fatigue management group, there was a significant improvement at the six-month follow-up in the fatigue management group compared to the control group; however, PSQI scores remained poor (> 5) at the six-month follow-up timepoint. Akbarfahimi et al 36 conducted a pilot RCT comparing an occupational therapy-based sleep intervention and care as usual as a control and found that sleep quality significantly improved in the intervention group compared to the control group.…”

“…29,36,54,61 One stated sleep was a primary outcome 36 . Two were RCTs 29 , one of which self-identified as a pilot RCT 36 , one utilized a single group pre-post study design, 54 and one was a retrospective chart review. 61 Hugos et al's 29 RCT study compared two 6-week group programs: one was a multi component fatigue management program and the other was a MS education program (control).…”