Clinical trial NCT04190771: Efficacy of NAT-FM Treatment for Fibromyalgia
Official title: Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Physical Activity, Psychological Support, and Nature Exposure (NAT-FM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: multicomponent treatment
Nature therapy
Mindfulness
Physical therapy
Pain Neuroscience Education (PNE)
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Universitat Autonoma de Barcelona
First posted: 2019-12-09
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, parallel-group, randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Through study completion, an average of 9 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Through study completion, an average of 9 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Through study completion, an average of 9 months
measure: Perceived Stress Scale (PSS)
timeFrame: Through study completion, an average of 9 months
measure: Personal Perceived Competence Scale (PPCS)
timeFrame: Through study completion, an average of 9 months
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Through study completion, an average of 9 months
measure: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: Through study completion, an average of 9 months
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Through study completion, an average of 9 months
measure: Ecological Momentary Assessment (EMA)
timeFrame: Through intervention completion, an average of 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebrón Hospital
Study officials:
affiliation: Vall d'Hebrón Hospital
name: Sara Marsal Barril, PhD
role: STUDY_CHAIR
References: