Efficacy of NAT-FM Treatment for Fibromyalgia

Study Overview
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Brief Summary
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The main objective of this study is to analyse the efficacy of the NAT-FM multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of NAT-FM treatment in the short- and long-term, the research team will seek to identify relevant moderators and mediators of clinical change.

Detailed Description
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This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program NAT-FM as coadjuvant of treatment-as-usual (TAU) vs. TAU alone. NAT-FM combines Classical Structural Assessment (CSA) and Ecological Momentary Assessment (EMA) to obtain more reliable information about the dynamics of the variables to be evaluated, to record the affective and cognitive impact of each activity, and to explore its potential delivery in real-world clinical practice. The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as self-efficacy and pain catastrophizing.

Official Title
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Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Physical Activity, Psychological Support, and Nature Exposure (NAT-FM)

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: TAU + multicomponent treatment NAT-FM
* Behavioral: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults from 18 to 75 years-old. 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia Able to understand Spanish and accept to participate in the study. Exclusion Criteria: Participating in concurrent or past RCTs (previous year). Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind, parallel-group, randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU + multicomponent treatment NAT-FM<br>NAT-FM is a multicomponent non-pharmacological program based on mindfulness ingredients, pain neuroscience education, and nature exposure. NAT-FM is conceived as an add-on therapy. | Behavioral: TAU + multicomponent treatment NAT-FM<br>* Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order): Pain neuroscience education (30 min.) Cognitive restructuring (30 min.) Mindfulness techniques (30 min.) Physical exercise in a natural environment / nature exposure (30 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.<br>Behavioral: Treatment as Usual (TAU)<br>* Standard pharmacological treatment usually provided to patients with fibromyalgia.<br>|
| Active Comparator: Treatment as Usual (TAU)<br>Standard Care. Although there is no treatment considered as the gold standard for fibromyalgia, the standard treatment is usually mainly pharmacological and conforms to the symptomatic profile of each patient. | Behavioral: Treatment as Usual (TAU)<br>* Standard pharmacological treatment usually provided to patients with fibromyalgia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Fibromyalgia Impact Questionnaire (FIQR) | The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration. | Through study completion, an average of 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Scale for Kinesiophobia (TSK-11) | TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement. | Through study completion, an average of 9 months | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADS-D) range from 0 to 21, where higher scores indicate greater severity of symptoms. | Through study completion, an average of 9 months | 
| Pain Catastrophizing Scale (PCS) | PCS is used to evaluate catastrophic thoughts associated with pain. It consists of three dimensions (rumination, magnification, and helplessness) of 13 items in total, which are answered on a Likert scale of 5 points. Total scores on each scale range from 0 to 52, with higher scores indicating more catastrophic thoughts. | Through study completion, an average of 9 months | 
| Perceived Stress Scale (PSS) | PSS is used to evaluate the stress perceived by people during the last month. This study will use a 4 item version. The response format of this scale is 5-point Likert type. Total scores range from 0 to 16, with higher scores indicating greater perceived stress. | Through study completion, an average of 9 months | 
| Personal Perceived Competence Scale (PPCS) | PPCS is used to measure perceived competence. It consists of 8 items that are answered on a 6-point Likert scale. Total scores of each scale range from 8 to 48, with higher scores indicating greater perceived competence. | Through study completion, an average of 9 months | 
| Rosenberg Self-Esteem Scale (RSES) | RSES is used to measure self-esteem. It consists of 10 items that are answered on a Likert scale of 4 points. Total scores of each scale range from 10 to 40, where higher scores indicate higher self-esteem. | Through study completion, an average of 9 months | 
| Cognitive Emotion Regulation Questionnaire (CERQ) | CERQ is used to assess individual differences in the cognitive regulation of emotions. The instrument measures nine 2-item dimensions (self-blame, blaming others, acceptance, refocusing on planning, positive refocusing, rumination, positive reappraisal, putting into perspective, and catastrophizing). This study will use the short version of 18 items. Responses are given on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Total scores for each dimension range from 2 to 10, with the highest scores indicating the specific cognitive strategy most used. | Through study completion, an average of 9 months | 
| Positive and Negative Affect Schedule (PANAS) | PANAS is used to evaluate positive and negative affect. It consists of two dimensions (positive affect and negative affect) of 10 items each answered on a Likert scale of 5 points. Total scores of each scale range from 10 to 50, where higher scores indicate a greater presence of the specific affectivity. | Through study completion, an average of 9 months | 
| Ecological Momentary Assessment (EMA) | Use of a commercial app used to assess daily (four times a day) the level of pain, fatigue, pain catastrophism during the monitoring period. | Through intervention completion, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multicomponent treatment, Nature therapy, Mindfulness, Physical therapy, Pain Neuroscience Education (PNE)