Back to resultsEfficacy of NAT-FM Treatment for Fibromyalgia (NAT-FM)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAU + multicomponent treatment NAT-FM
Treatment as Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring multicomponent treatment, Nature therapy, Mindfulness, Physical therapy, Pain Neuroscience Education (PNE)
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.
Sites / Locations
- Vall d'Hebrón Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TAU + multicomponent treatment NAT-FM
Treatment as Usual (TAU)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04190771
First Posted
December 5, 2019
Last Updated
October 14, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Parc Sanitari Sant Joan de Déu, Universitat Autonoma de Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT04190771
Brief Title
Efficacy of NAT-FM Treatment for Fibromyalgia
Acronym
NAT-FM
Official Title
Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Physical Activity, Psychological Support, and Nature Exposure (NAT-FM)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Parc Sanitari Sant Joan de Déu, Universitat Autonoma de Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
multicomponent treatment, Nature therapy, Mindfulness, Physical therapy, Pain Neuroscience Education (PNE)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, parallel-group, randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU + multicomponent treatment NAT-FM
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
TAU + multicomponent treatment NAT-FM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Standard pharmacological treatment usually provided to patients with fibromyalgia.
Primary Outcome Measure Information:
Title
Revised Fibromyalgia Impact Questionnaire (FIQR)
Description
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.
Time Frame
Through study completion, an average of 9 months
Secondary Outcome Measure Information:
Title
Tampa Scale for Kinesiophobia (TSK-11)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Perceived Stress Scale (PSS)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Personal Perceived Competence Scale (PPCS)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Rosenberg Self-Esteem Scale (RSES)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Cognitive Emotion Regulation Questionnaire (CERQ)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Positive and Negative Affect Schedule (PANAS)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Ecological Momentary Assessment (EMA)
Description
Use of a commercial app used to assess daily (four times a day) the level of pain, fatigue, pain catastrophism during the monitoring period.
Time Frame
Through intervention completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Marsal Barril, PhD
Organizational Affiliation
Vall d'Hebrón Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vall d'Hebrón Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of NAT-FM Treatment for Fibromyalgia
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