Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Physical Activity, Psychological Support, and Nature Exposure (NAT-FM)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Revised Fibromyalgia Impact Questionnaire (FIQR)
Study Overview
Brief Summary
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TAU + multicomponent treatment NAT-FM
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.
Intervention: TAU + multicomponent treatment NAT-FM (Behavioral)
Treatment as Usual (TAU)
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.
Intervention: Treatment as Usual (TAU) (Behavioral)
TAU + multicomponent treatment NAT-FM
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.
Intervention: Treatment as Usual (TAU) (Behavioral)
Outcomes
Primary Outcomes
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: Through study completion, an average of 9 months
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.
Secondary Outcomes
- Tampa Scale for Kinesiophobia (TSK-11)(Through study completion, an average of 9 months)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 9 months)
- Pain Catastrophizing Scale (PCS)(Through study completion, an average of 9 months)
- Personal Perceived Competence Scale (PPCS)(Through study completion, an average of 9 months)
- Perceived Stress Scale (PSS)(Through study completion, an average of 9 months)
- Cognitive Emotion Regulation Questionnaire (CERQ)(Through study completion, an average of 9 months)
- Rosenberg Self-Esteem Scale (RSES)(Through study completion, an average of 9 months)
- Ecological Momentary Assessment (EMA)(Through intervention completion, an average of 3 months)
- Positive and Negative Affect Schedule (PANAS)(Through study completion, an average of 9 months)