Online mindfulness therapy improves sarcoidosis-related fatigue
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Twelve weeks of online mindfulness-based cognitive therapy better alleviated sarcoidosis-related fatigue than standard care, according to study results published in The Lancet Respiratory Medicine.
“Fatigue is one of the most common symptoms of sarcoidosis, reported in up to 90% of patients,” Marlies Wijsenbeek, MD, PhD, head of the Center of Excellence for Interstitial Lung Diseases and Sarcoidosis at Erasmus Medical Center-University Medical Center Rotterdam, and colleagues told Healio.
“The management of fatigue is a great challenge for physicians in daily practice,” Wijsenbeek said, adding that this idea for this study was conceived together with the sarcoidosis patient association, and then conducted as a collaboration between the Erasmus Medical Center, St. Antonius Hospital, Zuyderland Medical Center and Helen Dowling Institute.
The multicenter, prospective, open-label randomized controlled trial included 99 adults (mean age, 50.4 years; 59% women) with sarcoidosis-associated fatigue.
Researchers sought to determine the impact of an online mindfulness-based cognitive therapy (eMBCT) for 12 weeks on fatigue using the Fatigue Assessment Scale (FAS), which consists of 10 questions that are answered on a 5-point Likert scale, with total scores ranging from 10 to 50. All patients scored greater than 21 points on the FAS at baseline, indicating fatigue.
Between-group changes in FAS score at 12 weeks served as the study’s primary endpoint.
The analysis included 47 patients in the standard care group and 46 patients in the eMBCT group. The online program consisted of psychoeducation, mindfulness exercises, a personal log with experiences and personalized feedback from a psychologist. Patients were asked to spend approximately 30 minutes per day on exercises for 6 days a week.
At baseline, both the eMBCT and standard care group had comparable FAS scores but, immediately after the intervention, researchers found a notable between-group difference (3.26; 95% CI, 1.18-5.33; P = .0025). In the eMBCT group, they observed a mean change of –4.53 in FAS score (standard deviation [SD], 5.77; P < .0001), whereas in the standard care group, they only saw a mean change of –1.28 (SD, 3.8; P = .026).
Twelve weeks after the intervention ended, those receiving eMBCT continued to show greater improvements in FAS score (–3.95; SD, 6.4; P = .0003) than those receiving standard care (–1.93; SD, 3.01; P < .0001; between-group difference, 2.02; 95% CI, –0.16 to 4.2).
The per-protocol analysis showed similar results to the main analysis, with the eMBCT group demonstrating larger improvements in fatigue than the standard care group, according to researchers.
Researchers observed a greater percentage of patients in the eMBCT group with clinically relevant improvement in FAS scores both immediately after the intervention (60% vs. 26%; P = .0008) and 12 weeks later (48% vs. 25%; P = .029).
Additionally, researchers evaluated changes in anxiety, depression, mindfulness and health status using the Hospital Anxiety and Depression Scale, the Freiburg Mindfulness Inventory-Short Form and the Kings Sarcoidosis Questionnaire. Directly after intervention, those receiving eMBCT also showed greater improvements in anxiety, depressive symptoms, mindfulness and general health status, with similar results after 12-week follow-up.
“The eMBCT program was firstly focused on improving fatigue,” Wijsenbeek told Healio. “Therefore, we were happy to see that eMBCT also improved anxiety, depression, mindfulness and health status and that these effects persisted during follow-up. Furthermore, the prevalence of anxiety and depressive symptoms was higher than we expected, as almost 50% of patients experienced these symptoms.”
Advantages of the program include that, because it’s online, patients can complete it at their own pace, and it’s currently reimbursed in the Netherlands, they added.
The researchers hope that future studies will focus on physical and psychological and nonpharmacological management for fatigue in this patient population, Wijsenbeek and colleagues told Healio.
“We envision that the best treatment option could depend on the underlying determinants of fatigue,” they said. “Patients with mental fatigue might benefit most from psychological interventions, whereas patients with physical fatigue might benefit more from physical based modalities. To provide better personalized tailored treatment, research is needed to identify factors that predict treatment success for nonpharmacological interventions.”
Mindfulness and fatigue trials face certain challenges, according to an accompanying editorial by Lesley Ann Saketkoo, MD, MPH, associate professor of medicine at Tulane University, and colleagues.
“Successful generalizability and patient engagement in mindfulness-type activities demands scientific rigor, and relies on addressing patient preferences, misperceptions and possibly past experiences,” Saketkoo and colleagues wrote. “Successful design demands expert input for optimized endpoint selection, placebo, sham, or intervention matching, randomization and implementation strategies that protect recruitment, blinding, inter-group equalization of non-essential intervention activities (eg, diaries and investigator interactions) as well as the reporting of standardized intervention, communication, surveillance, and data collection formats.”
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Marlies Wijsenbeek, MD, PhD, can be reached at m.wijsenbeek-lourens@erasmusmc.nl.