Effectiveness of an amygdala and insula retraining program combined with mindfulness training to improve the quality of life in patients with long COVID: a randomized controlled trial protocol.

BACKGROUND: There has been growing clinical awareness in recent years of the long-term physical and psychological consequences of the SARS-CoV-2 virus, known as Long COVID. The prevalence of Long COVID is approximately 10% of those infected by the virus. Long COVID is associated with physical and neuropsychological symptoms, including those related to mental health, psychological wellbeing, and cognition. However, research on psychological interventions is still in its early stages, in which means that available results are still limited. The main objective of this study is to evaluate the effects of a program based on amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) on the improvement of quality of life, psychological well-being, and cognition in patients with Long COVID. METHODS: This study protocol presents a single-blind randomized controlled trial (RCT) that encompasses baseline, post-treatment, and six-month follow-up assessment time points. A total of 100 patients diagnosed with Long COVID by the Spanish National Health Service will be randomly assigned to either AIR + Mindfulness (n = 50) or relaxation intervention (n = 50), the latter as a control group. The primary outcome will be quality of life assessed using the Short Form-36 Health Survey (SF-36). Additional outcomes such as fatigue, pain, anxiety, memory, and sleep quality will also be evaluated. Mixed effects regression models will be used to estimate the effectiveness of the program, and effect size calculations will be made. DISCUSSION: Long COVID syndrome is a clinical condition characterized by the persistence of symptoms for at least 12 weeks after the onset of COVID-19 that significantly affects people's quality of life. This will be the first RCT conducted in Spain to apply a psychotherapy program for the management of symptoms derived from Long COVID. Positive results from this RCT may have a significant impact on the clinical context by confirming the beneficial effect of the intervention program being evaluated on improving the symptoms of Long COVID syndrome and aiding the development of better action strategies for these patients. TRIAL REGISTRATION: Clinical Trials.gov NCT05956405. Registered on July 20, 2023.

Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial.

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

Feasibility and Effectiveness of a Workplace-Adapted Mindfulness-Based Programme to Reduce Stress in Workers at a Private Sector Logistics Company: An Exploratory Mixed Methods Study.

There is a high prevalence of stress in the logistics sector owing to very demanding, fast-paced and unpredictable tasks. Mindfulness-based programmes may reduce stress but require considerable practice. Our aim was to evaluate the feasibility and effectiveness of a shortened, workplace-adapted mindfulness-based programme for the logistics sector (WA-MBP-LS) for the purpose of reducing stress. A nonblinded, nonrandomised, two-arm controlled trial was conducted. The WA-MBP-LS (n = 32) consisted of six weekly 90-min mindfulness sessions. The control group (n = 36) attended a psycho-educational seminar. The Perceived Stress Scale (PSS) and Five Facets of Mindfulness Questionnaire (FFMQ) were measured at pretest, posttest and 6-month follow-up. Differences between groups were evaluated using mixed-effects models. Qualitative methods were used to analyse implementation issues. A 64.2% reduction was observed between initial volunteers and actual participants. Attrition at six-month follow-up was 45.6%. Participants attended a median of five sessions. Decreases in PSS favoured the WA-MBP-LS group at posttest and follow-up. FFMQ played a mediating role in PSS reductions. Barriers were disinterest, lack of programming, work overload and absences from work. Facilitators were curiosity, timing, company facilities and audio recordings. The WA-MBP-LS was feasible and effective in reducing stress, but more efforts to improve the practicalities of implementation are desirable.