c834ebcc7506cdcf2c9fe0c5d12532d0 jouclimed_a2020v9n10p3348.pdf 91cf8c5cb0bb74f21018d7d21e6c64807f4b9aa4 jouclimed_a2020v9n10p3348.pdf 7e9190d26f511afd1d8c93abc433094d30e48689a9f82b429672710b7111d2b4 jouclimed_a2020v9n10p3348.pdf Title: 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 Subject: 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. Keywords: fibromyalgia; multicomponent treatment; pain neuroscience education; exercise therapy; cognitive behavioral therapy; mindfulness; nature exposure; randomized controlled trial Author: Mayte Serrat, Míriam Almirall, Marta Musté, Juan P. Sanabria-Mazo, Albert Feliu-Soler, Jorge L. Méndez-Ulrich, Juan V. Luciano and Antoni Sanz Creator: LaTeX with hyperref package Producer: pdfTeX-1.40.15 CreationDate: Wed Oct 21 10:09:33 2020 CEST ModDate: Wed Oct 21 10:15:58 2020 CEST Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 24 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1458171 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- YSPQJI+VnURWPalladioL-Bold Type 1 Custom yes yes no 10 0 IYDCBB+VnURWPalladioL Type 1 Custom yes yes no 15 0 UBISVG+URWPalladioL-Ital Type 1 Custom yes yes no 19 0 VFDHQI+URWPalladioL-Bold Type 1 Custom yes yes no 24 0 UBLVLK+Rpxb Type 1 Builtin yes yes no 28 0 GEGDJE+URWPalladioL-Roma Type 1 Custom yes yes no 32 0 FATHTC+Rpxr Type 1 Builtin yes yes no 36 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 44 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 47 0 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yes no 202 0 MCNAHK+TimesNewRoman CID TrueType Identity-H yes yes yes 205 0 GCGGOA+PalatinoLinotype CID TrueType Identity-H yes yes yes 224 0 GCGGOB+PalatinoLinotype TrueType WinAnsi yes yes no 230 0 GCGHDB+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 233 0 GCGHDD+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 236 0 GCGJBI+TimesNewRoman CID TrueType Identity-H yes yes yes 239 0 CRUZTT+VnURWPalladioL-Italic Type 1 Custom yes yes no 268 0 VSHNAE+Rpcxr Type 1 Builtin yes yes no 275 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2020-11-18 07:10:03 CET RepresentationInformation: jouclimed_a2020v9n10p3348.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2020-11-11 12:37:43 CET Size: 1458171 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 510 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@13c27452 Item: Title: Materials and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Children: Item: Title: Design Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@371a67ec Item: Title: Participants Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@5ed828d Item: Title: Procedure Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@50d0686 Item: Title: Study Arms Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7a3d45bd Children: Item: Title: TAU + NAT-FM Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1e7c7811 Item: Title: TAU Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77ec78b9 Item: Title: Outcome Measures Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1a3869f4 Children: Item: Title: Classical Structural Assessment (CSA) at Specific Time Points Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@a38d7a3 Item: Title: Ecological Momentary Assessment (EMA) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77f99a05 Item: Title: Statistical Analysis Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@63440df3 Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@3aeaafa6 Children: Item: Title: Baseline Sociodemographic and Clinical Characteristics of the Groups Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@76a3e297 Item: Title: Effects on Functional Impairment (Primary Outcome) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4d3167f4 Item: Title: Effects on Pain, Fatigue, Anxiety-Depression, Physical Functioning, Positive and Negative Affect, Self-Esteem, and Perceived Stress (Secondary Outcomes) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@ed9d034 Item: Title: Effects on Kinesiophobia, Pain Catastrophizing, Personal Perceived Competence, and Cognitive Emotion Regulation (Process Variables) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@6121c9d6 Item: Title: Number Needed to Treat Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@87f383f Item: Title: Effects of the Different Activities Included in TAU + NAT-FM Treatment: Intra-Session Assessments (EMA) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4eb7f003 Item: Title: The Role of Kinesiophobia, Pain Catastrophism, Perceived Competence, and Cognitive Emotion Regulation Strategies as Treatment Mediators Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@eafc191 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@612fc6eb Item: Title: Conclusions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1060b431 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@612679d6 Info: Title: 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 Author: Mayte Serrat, Míriam Almirall, Marta Musté, Juan P. Sanabria-Mazo, Albert Feliu-Soler, Jorge L. Méndez-Ulrich, Juan V. Luciano and Antoni Sanz Subject: 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. 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