A 12-week multicomponent therapy in fibromyalgia improves health but not in concomitant moderate depression, an exploratory pilot study

Ollevier, Aline; Vanneuville, Isabelle; Carron, Philippe; Baetens, Tina; Goderis, Tania; Gabriel, Linda; Velde, Dominique Van de

doi:10.1080/09638288.2018.1543361

Cited by 14 publications

(19 citation statements)

References 24 publications

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“…The responder group had higher BMI, age, years of illness and perspective, and lower baseline scores on anxiety, depression, and pain catastrophizing thoughts. The non-responder group, as shown in the TAU + NAT-FM and FIBROWALK intervention, had, at least, higher scores on depression according to previous literature [ 27 , 69 , 70 ].…”

Section: Discussionsupporting

confidence: 59%

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

Serrat

Almirall

Musté

et al. 2020

JCM

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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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Section: Discussionsupporting

confidence: 59%

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

Serrat

Almirall

Musté

et al. 2020

JCM

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“…A recent study on multicomponent therapy in FM, dropouts were associated with moderate to severe depression. 62 cultures. An aspect that merits attention in future studies is the assessment of patients' stages of change, because we think that this aspect might account for variability in treatment adherence and moderate the impact of the intervention on treatment outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…Related to this, practicing skills outside of the group is considered of crucial importance for improving outcomes in this kind of therapies, but adherence to home practice was not systematically measured in our RCT. Second, as recently highlighted by Ollevier and colleagues,62 there is a need for empirical evidence for the efficacy of multicomponent, long-term therapies. In our case it was not possible to follow up the control group beyond a period of 3 months post-intervention, due to ethical reasons.An assessment of the long-term effectiveness of Fibrowalk is necessary in the context of real-world clinical practice using an active treatment as comparator.…”

mentioning

confidence: 99%

Effectiveness of a Multicomponent Treatment based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients with Fibromyalgia (FIBROWALK study): A Randomized Controlled Trial.

Serrat

Sanabria‐Mazo

Almirall³

et al. 2020

Preprint

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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.

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“…A pilot study conducted in rehabilitation centers in Belgian hospitals showed an improvement regarding the impact of FM, pain in tender-points and other health parameters at the end of a multicomponent therapy lasting 12 weeks that combined exercise and CBT, with the exception of patients with moderate depression. [18] In this study improvement started after 6 weeks of therapy, but no information is provided on the duration of the beneficial effects.…”

Section: Discussionmentioning

confidence: 99%

“…Some studies have shown clinical improvement with non-pharmacological therapies, particularly with exercise [14] and with cognitive-behavioral therapy (CBT). [15,16] There is also some evidence on the effectiveness of multicomponent group therapy, which involves patient education, exercise and CBT [17,18] , with reported clinical improvement that lasts 3 to 12 months after the intervention. [19,20] Interdisciplinary interventions conducted from hospitals [21–23] and PC [24–27] have obtained similar positive results.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care

et al. 2019

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Introduction:Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS).Methods and analysis:A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l’Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. Analysis: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out.Ethics and dissemination:This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals.Trial registration:Clinical-Trials.gov: NCT04049006.

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A 12-week multicomponent therapy in fibromyalgia improves health but not in concomitant moderate depression, an exploratory pilot study

Cited by 14 publications

References 24 publications

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

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

Effectiveness of a Multicomponent Treatment based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients with Fibromyalgia (FIBROWALK study): A Randomized Controlled Trial.

Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care

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