Dataset Information

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

ABSTRACT: 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-?, 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.

SUBMITTER: Sanabria-Mazo JP

PROVIDER: S-EPMC7599726 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Sanabria-Mazo Juan P JP Montero-Marin Jesus J Feliu-Soler Albert A Gasión Virginia V Navarro-Gil Mayte M Morillo-Sarto Héctor H Colomer-Carbonell Ariadna A Borràs Xavier X Tops Mattie M Luciano Juan V JV García-Campayo Javier J

Journal of clinical medicine 20201011 10

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 ...[more]

PMID: 33050630

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Project description:BackgroundThere 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.MethodsThis 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.DiscussionLong 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 registrationClinical Trials.gov NCT05956405. Registered on July 20, 2023.

Project description:We studied the effects of a specific cardio training program lasting 5 years on pain and quality of life in fibromyalgia patients.MethodAn observational longitudinal pilot study was conducted in 138 fibromyalgia women. Fibromyalgia women recruited were asked to carry out three sessions per week, each lasting 45 min, of moderate-intensity continuous training (64%-75% Maximal Heart rate [HRmax]). During the first year, the patients progressively increased their training intensity. During the last 2 years, the patients were asked to associate moderate-intensity continuous training and high-intensity interval training (85%-90% HRmax). Pain on a visual analog scale, anxiety and depression state on the Hospital Anxiety and Depression Scale, impact of fibromyalgia on daily life using the Fibromyalgia Impact Questionnaire, heart rate and sleep quality (visual analog scale) were assessed at baseline and each year for 5 years.ResultsForty-nine patients dropped out in the first year. Depending on their training status, the remaining 89 patients were retrospectively assigned to one of the three groups: Active (moderate-intensity continuous training), Semi-Active (one or two sessions, low-intensity continuous training <60% HRmax) and Passive (non-completion of training), based on their ability to comply with the program. Alleviation of all symptoms (p < 0.0001) was observed in the Active group. Increasing exercise intensity enhanced the effects obtained with moderate-intensity continuous training. Significant change in the Fibromyalgia Impact Questionnaire (p < 0.0001) and depression (Hospital Anxiety and Depression Scale; p < 0.0001), and no significant decrease in pain were noted in the Semi-Active group. No effect of the training was observed in the Passive group.ConclusionThe study intervention associated with multidisciplinary care alleviated pain, anxiety and depression, and improved both quality of life and quality of sleep, in fibromyalgia patients.

Project description:BackgroundEvidence suggests that aerobic training with blood flow restriction is beneficial for treating fibromyalgia. This study evaluated the feasibility, safety, and effects of an aerobic training program with blood flow restriction for women with fibromyalgia.MethodsThirty-seven women with fibromyalgia were included, and thirteen with an average age of 59 ± 3, a BMI of 26 ± 3, and who were polymedicated started the intervention period. The intervention group performed aerobic exercise with blood flow restriction using occlusive bands placed in the upper part of the rectus femoris, with a total duration of 14 min of restriction divided into two periods of 7 min with a rest period of 3 min and a total session duration of 17 min. Pressure intensity was measured using the visual pain scale (VAS), scoring 7 out of 10 (n = 7). The non-intervention group performed aerobic exercise without restriction of blood flow for the same periods, rest periods, and total duration of the session (n = 6). The intervention included 2 weekly sessions with 72 h between aerobic walking for 9 weeks. Walking was measured individually using the rating of perceived exertion scale (RPE) with an intensity between 6 and 7 out of 10. Visual and verbal support for the VAS and RPE scale was always provided throughout the sessions supervised by the investigator. Functional capacity was assessed using tests (six-minute walk test, incremental shuttle walk test, knee extension and handgrip test by dynamometer, 30 s chair stand test, and timed up-and-go test). Symptomatology was assessed using questionnaires (Widespread Pain Index, Symptom Severity Score, Fibromyalgia Impact Questionnaire, and Multidimensional Fatigue Inventory), and blood samples were collected.ResultsThere were no adverse effects, and only one participant in the intervention group withdrew. Between-group and intragroup differences showed that the intervention group obtained improvements in the functional tests; CST p = 0.005; 6MWT p = 0.011; Handgrip p = 0.002; TUGT p = 0.002 with reduced impact of the disease according to the questionnaires; FIQ Stiffness p = 0.027 compared with the nonintervention group. Biochemical results remained within normal ranges in both groups.ConclusionsBlood flow-restricted aerobic training may be feasible, safe, and more effective than unrestricted aerobic training as a physical exercise prescription tool to improve cardiorespiratory fitness, strength, balance, and stiffness in women with fibromyalgia.

Dataset Information

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

Publications

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

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