NCT04190771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

December 5, 2019

Last Update Submit

October 14, 2020

Conditions

Fibromyalgia

Keywords

multicomponent treatmentNature therapyMindfulnessPhysical therapyPain Neuroscience Education (PNE)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • Perceived Stress Scale (PSS)

    Through study completion, an average of 9 months

  • Personal Perceived Competence Scale (PPCS)

    Through study completion, an average of 9 months

  • +4 more secondary outcomes

Study Arms (2)

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.

Behavioral: TAU + multicomponent treatment NAT-FMBehavioral: Treatment as Usual (TAU)

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.

Behavioral: Treatment as Usual (TAU)

Interventions

TAU + multicomponent treatment NAT-FMBEHAVIORAL

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.

TAU + multicomponent treatment NAT-FM
Treatment as Usual (TAU)BEHAVIORAL

Standard pharmacological treatment usually provided to patients with fibromyalgia.

TAU + multicomponent treatment NAT-FMTreatment as Usual (TAU)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults from 18 to 75 years-old.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebrón Hospital

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Sara Marsal Barril, PhD

    Vall d'Hebrón Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind, parallel-group, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 9, 2019

Study Start

September 1, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)