Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial.

BACKGROUND/OBJECTIVES: The aim of this study was to examine the effectiveness of two video-based multicomponent programs (FIBROWALK) and the Multicomponent Physiotherapy Program (MPP) for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only. We posit that FIBROWALK, due to inclusion of specific psychological ingredients (cognitive restructuring and mindfulness), can produce additional clinical benefits when compared to TAU or MPP alone. METHODS: A total of 330 patients with FM were recruited and randomly allocated (1:1:1) to TAU only, TAU + FIBROWALK, or TAU + MPP. FIBROWALK and MPP consisted of weekly videos on pain neuroscience education, therapeutic exercise and self-management patient education, but only the FIBROWALK intervention provided cognitive restructuring and mindfulness. Both programs were structurally equivalent. Between-group differences in functional impairment, pain, kinesiophobia, anxious-depressive symptoms and physical functioning were evaluated at post-treatment following Intention-To-Treat and complete-case approaches. RESULTS: Compared to TAU only, individuals in the FIBROWALK arm showed larger improvements in all clinical outcomes; similarly, participants in the MPP program also showed greater improvements in functional impairment, perceived pain, kinesiophobia, depressive symptoms compared to TAU only. The FIBROWALK intervention showed superior effects in improving pain, anxiety and depressive symptoms and physical functioning compared to MPP. CONCLUSIONS: This RCT supports the short-term effectiveness of the video-based multicomponent programs FIBROWALK and MPP for FM and provides evidence that cognitive-behavioural and mindfulness-based techniques can be clinically useful in the context of physiotherapeutic multicomponent treatment programs. TRIAL REGISTRATION NUMBER: NCT04571528.

Mechanisms of change in multicomponent group-based treatment for patients suffering from medically unexplained physical symptoms.

Understanding psychological mechanisms of change is essential to advance treatments for patients suffering from medically unexplained physical symptoms (MUPS). This study aimed to test the role of selected change mechanisms (incl. interoceptive awareness, emotional regulation skills, symptom acceptance, relational needs satisfaction, clarification of meaning, working alliance, and group cohesion) in the modification of patients' somatic symptom intensity and well-being.N = 290 patients suffering from MUPS participated in a multi-component group-based treatment at seven clinical sites. Data were collected weekly. Multi-level modeling was used to test cross-lagged relationships between the hypothesized mechanisms and outcomes in terms of Granger causality (with lags of 1, 2, and 3 weeks).None of the mechanisms predicted a time-lagged change in outcomes in the expected direction. In fact, there was a consistent pattern of negative time-lagged relationships (i.e., an increase in a mechanism predicted worsening of the outcome). Findings consistent with the hypothesized role of the mechanisms were found only in concurrent relationships between mechanisms and outcomes.This study did not support time-lagged relationships under the condition of weekly measurement and many methodological factors remain to be considered (e.g., a finer time resolution).

Effectiveness of multicomponent treatment in patients with fibromyalgia: protocol for a systematic review and meta-analysis.

BACKGROUND: The purpose of this protocol is to provide a new systematic review with meta-analysis using the current methodology to compare the effectiveness of multicomponent treatment versus other interventions for patients with fibromyalgia. METHODS: This protocol conforms to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) and the recommendations of the Cochrane Collaboration Handbook. An electronic search will be conducted in MEDLINE, EMBASE, Web of Science, Cochrane CENTRAL, LILACS, CINAHL, and PEDro, from inception until April 2022. There will be no language restrictions. The Cochrane Collaboration tool for assessing the risk of bias (RoB2) will be used. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scale will be used to evaluate the strength of the evidence. The Hartung-Knapp-Sidik-Jonkman random effects or Mantel-Haenszel fixed effects methods will be used, depending on the heterogeneity, to compute a pooled estimate of the mean difference (MD) or standardized mean difference (SMD) and respective 95% confidence intervals for clinical outcomes. DISCUSSION: This systematic review will synthesize evidence on the effectiveness of multicomponent treatment in patients with fibromyalgia and could add important evidence in the treatment of FM to improve clinical practice and decision-making/actions in this field. This new systematic review will try to show the effects of multicomponent treatment by type (endurance, resistance, stretching, or mind-body exercises [pilates or taichi]) and intensity (light, moderate, moderate-to-vigorous, vigorous) of exercise in patients with FM. The results will be disseminated by publication in a peer-reviewed journal. Ethics approval will not be needed because the data used for this systematic review will be obtained from individual trials and there will be no concerns about privacy. However, if we identify ethical issues during the development of the systematic review, these findings will be reported in the discussion of the study. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020142082.

Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic: A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain.

FIBROWALK is a multicomponent program including pain neuroscience education, therapeutic exercise, cognitive behavioral therapy and mindfulness training that has recently been found to be effective in patients with fibromyalgia (FM). This RCT started before the COVID-19 pandemic and was moved to a virtual format (i.e., online videos) when the lockdown was declared in Spain. This study is aimed to evaluate the efficacy of a virtual FIBROWALK compared to Treatment-As-Usual (TAU) in patients with FM during the first state of alarm in Spain. A total of 151 patients with FM were randomized into two study arms: FIBROWALK plus TAU vs. TAU alone. The primary outcome was functional impairment. Secondary outcomes were kinesiophobia, anxiety and depressive symptomatology, and physical functioning. Differences between groups at post-treatment assessment were analyzed using Intention-To-Treat (ITT) and completer approaches. Baseline differences between clinical responders and non-responders were also explored. Statistically significant improvements with small-to-moderate effect sizes were observed in FIBROWALK+TAU vs. TAU regarding functional impairment and most secondary outcomes. In our study, the NNT was 5, which was, albeit modestly, indicative of an efficacious intervention. The results of this proof-of-concept RCT preliminarily support the efficacy of virtual FIBROWALK in patients with FM during the Spanish COVID-19 lockdown.

Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial.

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 with treatment as usual only in patients with fibromyalgia. 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 as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, 12 weeks, and, for the multicomponent group only, 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% Revised Fibromyalgia Impact Questionnaire 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). CONCLUSION: 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. IMPACT: Despite some methodological shortcomings in the design of this study, the multicomponent therapy FIBROWALK can be considered a novel and effective treatment for patients with fibromyalgia. Physical therapists should detect patients with clinically relevant depression levels prior to treatment because depression can buffer treatment effects. LAY SUMMARY: Fibromyalgia is prevalent and can be expensive to treat. This multicomponent treatment could significantly improve the core symptoms of fibromyalgia compared with usual treatment.

Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial.

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.

Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial.

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.

El tratamiento grupal multicomponente: un método efectivo contra el tabaquismo / Group multicomponent treatment: an effective method against nicotinism

RESUMEN Introducción: El tabaquismo es una enfermedad crónica perteneciente al grupo de las adicciones. En Cuba existen pocas referencias de publicaciones que midan el resultado de estrategias psicoterapéuticas. Objetivo: Evaluar los resultados alcanzados en pacientes que durante un año recibieron tratamiento grupal multicomponente para la cesación tabáquica. Métodos: Investigación descriptiva longitudinal de corte evaluativo. Se evaluaron los resultados en 83 fumadores que recibieron un año de tratamiento multicomponente para la cesación tabáquica en el Departamento de Salud Mental de Plaza de la Revolución. Se aplicó encuesta y se determinó niveles de monóxido de carbono y carboxihemoglobina. Resultados: Al año de tratamiento, 42,1 % se mantenía sin fumar, 21,7 % disminuyó el consumo. Aunque acudieron más féminas a recibir ayuda, un mayor número de hombres logró la abstinencia. De los abstinentes, solo 10 señalaron convivir con fumadores, ninguno tenía antecedentes personales de alcoholismo y 11,4 % estaba en fase precontemplativa o contemplativa. 91,4 % de los exfumadores no tenían intoxicación por monóxido de carbono. En contraposición, 91,7 % de los que seguían fumado tenían niveles moderados de carboxihemoglobina. Los principales beneficios fueron mejoría de salud y de economía, de forma grupal se produjo un ahorro de 191 625 pesos. La totalidad de los pacientes refirió satisfacción con el tratamiento recibido brindando sugerencias para su perfeccionamiento. Conclusiones: La aplicación del tratamiento multicomponente para la cesación tabáquica es satisfactorio, a pesar de ser el tabaquismo una adicción difícil de controlar Se aporta información útil, sobre la deshabituación tabáquica en contextos clínicos, que permite perfeccionar las acciones de cesación.

ABSTRACT Introduction: Smoking habit is a chronic disease belonging to the group of addictions. In Cuba there are few references of publications that measure the result of psychotherapeutic strategies against this habit. Objective: To evaluate the results achieved in patients that during one year received a group multicomponent treatment for smoking cessation. Method: Descriptive longitudinal research of evaluative type. The results were evaluated in 83 smokers a year after receiving multicomponent treatment for smoking cessation in the Department of Mental Health of Plaza de la Revolución municipality. A survey was applied and levels of carbon monoxide and carboxyhemoglobin were determined. Results: 42,1 % of the patients keep without smoking a year after treatment, 21,7 % decreased consumption. Although more women went to receive help, a greater number of men achieved abstinence. Of the abstinents only 10 reported living with smokers, none had personal history of alcoholism and the 11,4 % was in pre-completion or completion phase. 91,4 % of former smokers had no carbon monoxide poisoning. In contrast, 91,7 % of those who continued to smoke had moderate levels of carboxyhemoglobin. The main benefits were improvement of health and economy, and as a group there was a pocket saving of 191 625 pesos. All patients expressed satisfaction with the treatment received and offered suggestions for its improvement. Conclusions: The results of the use of the multicomponent treatment for smoking cessasion are satisfactory, instead of being nicotinism an addiction which is hard to control. It was provided information on smoking cessation in clinical contexts that allows improving cessation actions.

Willing to go the extra mile: Prospective evaluation of an intensified non-surgical treatment for patients with morbid obesity.

BACKGROUND & AIMS: Bariatric surgery has been well established and considered the treatment of choice in morbid obesity. However, some patients refuse surgery because long-term effects have not been fully elucidated, quality of life might change and lifelong supplementation with vitamins and trace elements may be required. Our aim was to exhaust non-surgical treatment modalities and to evaluate such an intensified treatment alternative. METHODS: A total of 206 patients (mean age = 46 years; BMI = 49 kg/m2) enrolled since 2013 into a non-surgical multimodality obesity treatment program covered by major health insurances were prospectively evaluated over a three year period. The 12-month treatment course comprised 57 h cognitive-behavioral therapy, 53.5 h physical exercise training, and 43.5 h nutritional therapy offered in small groups. Weight loss was induced by a formula-based, very low-calorie diet for 12 weeks in combination with a gastric balloon. The primary outcome was relative weight loss (RWL). Secondary outcome measures were waist-to-hip ratio, blood pressure, antihypertensive drug treatment, anti-diabetic medication, HbA1c, and quality of life. RESULTS: 166 Patients (81%) completed treatment. Mean (±SD) weight loss after 12 months for women and men were 28.8 kg (±14.7) and 33.7 kg (±19.5), respectively, among completers. RWL was 21.9% (±10.0) and excess weight loss (EWL) was 46.9% (±22.2), whereas intention-to-treat analysis revealed a RWL of 20.0% (±10.4) and an EWL of 42.9% (±22.9). Weight loss was accompanied by improved quality of life, lowered HbA1c values, and a significantly reduced need of antihypertensive and diabetes medications over the study period. Three year follow-up data from the first 78 patients (76% follow-up rate) revealed a RWL of 13% (±13.1) and an EWL of 27.2% (±28.8). The majority of patients (51%) maintained a RWL of 10% or more, and 44% had an EWL > 30%. CONCLUSIONS: In patients with morbid obesity, an intensified non-surgical multimodality treatment program may achieve significant and sustained weight loss accompanied by improvement of disease markers as well as quality of life for at least three years.

Enhanced response using a multicomponent urine alarm treatment for nocturnal enuresis.

PURPOSE: The current study investigated the effects of using the combination of a urine alarm and simple reward system to treat nocturnal enuresis (NE) for three children who failed to fully respond to the urine alarm alone. DESIGN AND METHODS: A withdrawal design (i.e., ABACA) embedded within a delayed multiple baseline design across participants was used to evaluate the effects of the urine alarm alone and in combination with a reward system on participants' frequency of wet nights per week. Results were analyzed through visual and descriptive methods. RESULTS: The urine alarm in combination with a reward system resulted in improvements in all three participants' NE. These results are contrasted with the urine alarm alone, which produced less frequent dry nights. PRACTICE IMPLICATIONS: Nursing professionals in primary care settings are positioned to provide evidence-based treatment recommendations to families with children with NE. Findings from the current study provide a promising approach to the treatment of NE for those children who fail to respond fully to the urine alarm.