A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6–3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.
Objective. The purpose of this study was to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness—in addition to treatment as usual—compared to treatment as usual only in patients with fibromyalgia (FM). Methods. This randomized controlled trial involved a total of 272 patients who were randomly assigned to either multicomponent treatment (n = 135) or treatment as usual (n = 137). The multicomponent treatment (2-hour weekly sessions) was delivered in groups of 20 participants. Treatment as usual was mainly based on pharmacological treatment according to the predominant symptoms. Data on functional impairment using the Revised Fibromyalgia Impact Questionnaire (FIQR) as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% FIQR reduction) and nonresponders also were analyzed, and the number needed to treat was computed. Results. At posttreatment, significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found in functional impairment, pain, kinesiophobia, and physical function, whereas differences with a moderate size effect (Cohen d > 0.50 and < 0.80) were found in fatigue, anxiety, and depressive symptoms. Nonresponders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI = 1.7–2.3). Conclusions. Compared with usual care, there was evidence of short-term (up to 3 months) positive effects of the multicomponent treatment for fibromyalgia. Some methodological shortcomings (eg, absence of follow-up in the control group and monitoring of treatment adherence, potential research allegiance) preclude robust conclusions regarding the proposed multicomponent program.
The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.
Methods. A randomised controlled trial (RCT) was carried out to evaluate the effectiveness of a 12-week multicomponent treatment based on Pain Neuroscience Education, therapeutic exercise, Cognitive Behavioural Therapy and Mindfulness Training, in addition to Treatment As Usual (TAU), compared with TAU only in patients with Fibromyalgia (FM). Data were collected on the Revised Fibromyalgia Impact Questionnaire (FIQR) (primary outcome), and pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at six and nine months. An intention to treat (ITT) approach was used to analyse between-group differences. The effect size (Cohen's d) was reported for each pairwise comparison. Differences in baseline variables between responders (> 20% FIQR reduction) and non-responders were compared using the Student's t-test (quantitative variables) and χ²-test (categorical variables). Results. A total of 272 patients with FM were randomly assigned to either the multicomponent group (n = 135), who received the multicomponent treatment plus TAU or the TAU group (n = 137), who received TAU alone. Significant differences (p < .001) with a large effect size (Cohen’s d > 0.80) between the multicomponent group and TAU group were found for functional impact, pain, kinesiophobia, and physical function, whilst differences with a moderate size effect (Cohen’s d > 0.50 and < 0.80) were found for fatigue, anxiety, and depressive symptoms. For all the baseline variables the non-responders showed a low effect size for depressive symptoms (Cohen’s d < 0.50). The number needed to treat (NNT) was 2 (95%CI 1.7 - 2.3).Conclusions. These results indicate that, when compared with TAU, this multicomponent treatment leads to beneficial effects in improving FM-related symptoms.Impact statement. ●This is the first study showing the beneficial effects of a multicomponent treatment that specifically integrates PNE in patients with Fibromyalgia.●This work provides new and useful information to promote a paradigm shift in the management of both FM and chronic pain.
The identification of general population groups particularly vulnerable to the impact of COVID-19 lockdown measures on mental health and the development of healthcare policies are priority challenges in the current and future pandemics. This study aimed to identify the personal and social determinants of the impact of COVID-19 lockdown measures on mental health in a large sample of the Colombian population. In this cross-sectional study, an anonymous online survey was answered by 18,061 participants from the general population residing in Colombia during the first wave of the COVID-19 outbreak (from 20 May to 20 June 2020). The risk of depression, anxiety, and somatization disorders were measured using the Patient Health Questionnaire (PHQ-2), Generalized Anxiety Disorder Scale (GAD-2), and Somatic Symptom Questionnaire (SSQ-5), respectively. Overall, 35% of participants showed risk of depression, 29% of anxiety, and 31% of somatization. According to the analysis of social determinants of health, the most affected groups were people with low incomes, students, and young adults (18–29 years). Specifically, low-income young females were the most at-risk population group. These findings show how the lockdown measures affected the general population’s mental health in Colombia and highlight some social risk factors in health.
The burnout syndrome is the consequence of chronic stress that overwhelms an individual’s resources to cope with occupational or academic demands. Frenetic, under-challenged, and worn-out are different burnout subtypes. Mindfulness has been recognized to reduce stress, comprising five facets (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). This cross-sectional study aimed to assess the relationship between mindfulness facets, perceived stress, and burnout subtypes in a sample of 1233 students of Education, Nursing, and Psychology degrees from different universities of Valencia (Spain). Structural Equation Modelling (SEM) was computed showing an adequate fit (Chi-square, CFI, TLI, RMSEA, and SRMR). Four mindfulness facets (all but observing) significantly correlated with general second-order mindfulness. Unexpected results were found: Acting with awareness facet was positively associated with frenetic subtype, while the non-reacting facet was positively associated with frenetic and under-challenged subtype. Ultimately, mindfulness facets negatively predicted the perceived stress levels, which in turn, predicted burnout. However, mindfulness plays different roles in the early stages of burnout syndrome (i.e., frenetic and under-challenged).
IntroductionThe IMPACT study focuses on chronic low back pain (CLBP) and depression symptoms, a prevalent and complex problem that represents a challenge for health professionals. Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively. The objectives of this 12 month, multicentre, randomised, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding a group-based form of ACT or BATD to treatment-as-usual (TAU) for patients with CLBP and moderate to severe levels of depressive symptoms; (ii) identify pre–post differences in levels of some physiological variables and (iii) analyse the role of polymorphisms in the FKBP5 gene, psychological process measures and physiological variables as mediators or moderators of long-term clinical changes.Methods and analysisParticipants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain) and Hospital del Mar (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+ACT versus TAU+BATD. A comprehensive assessment to collect clinical variables and costs will be conducted pretreatment, post-treatment and at 12 months follow-up, being pain interference the primary outcome measure. The following physiological variables will be considered at pretreatment and post-treatment assessments in 50% of the sample: immune-inflammatory markers, hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin and vitamin D. Polymorphisms in the FKBP5 gene (rs3800373, rs9296158, rs1360780, rs9470080 and rs4713916) will be analysed at baseline assessment. Moreover, we will include mobile-technology-based ecological momentary assessment, through the Pain Monitor app, to track ongoing clinical status during ACT and BATD treatments. Linear mixed-effects models using restricted maximum likelihood, and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Ethics and disseminationThis study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu and Hospital del Mar. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities.Trial registration numberNCT04140838
El objetivo de esta investigación fue comprender las repercusiones del dolor crónico en las dinámicas de pareja, desde la perspectiva de mujeres con fibromialgia. Se realizó un estudio cualitativo de diseño fenomenológico interpretativo en el cual se entrevistó a 15 mujeres. Las participantes reportaron inconformidad con el cambio de su rol en la relación. Además, ocultar el dolor fue una estrategia para evitar la sobreprotección y los conflictos. Las repercusiones en la percepción de la relación, los espacios compartidos, el apoyo de la pareja, la comunicación y la sexualidad se asociaron con la interferencia de los síntomas. Finalmente, la aparición de la enfermedad fue una oportunidad para fortalecer o fragmentar la relación.
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