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| Name | Class |
|---|---|
| Parc Sanitari Sant Joan de Déu | OTHER |
| Universitat Autonoma de Barcelona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU + multicomponent treatment NAT-FM | Experimental | 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. |
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| Treatment as Usual (TAU) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAU + multicomponent treatment NAT-FM | Behavioral | Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order):
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Marsal Barril, PhD | Vall d'Hebrón Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d'Hebrón Hospital | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Single-blind, parallel-group, randomized controlled trial
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| Treatment as Usual (TAU) | Behavioral | Standard pharmacological treatment usually provided to patients with fibromyalgia. |
|
| 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 |
| D009422 |
| Nervous System Diseases |