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Effectiveness of VIRTUAL SFCAMINA STUDY (SFCAMINA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593225
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : December 30, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
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Brief Summary:
The main objective of this study is to analyse the effectiveness of the VIRTUAL SFCAMINA multicomponent treatment program as coadjuvant of treatmentas- usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL SFCAMINA treatment in the short- and long term.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Behavioral: TAU + multicomponent treatment VIRTUAL SFCAMINA Behavioral: Treatment as Usual (TAU) Not Applicable

Detailed Description:

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL SFCAMINA as coadjuvant of treatmentas- usual (TAU) vs. TAU alone.

  • VIRTUAL SFCAMINA combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
  • The main hypothesis is that improvement on fatigue of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia, fear avoidance and by individualized therapeutic exercise.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Virtual Multicomponent Treatment for Chronic Fatigue Syndrome: VIRTUAL SFCAMINA STUDY
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : December 21, 2021
Estimated Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAU + multicomponent treatment VIRTUAL SFCAMINA
VIRTUAL SFCAMINA is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
 Behavioral: TAU + multicomponent treatment VIRTUAL SFCAMINA
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): - Pain neuroscience education (15 min.) - Cognitive restructuring (15 min.) - Mindfulness techniques (15 min.) - Physical exercise(15 min.) - Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with SFC.
Active Comparator: Treatment as Usual (TAU)
Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.patient
 Behavioral: Treatment as Usual (TAU)
Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.


Outcome Measures
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Primary Outcome Measures :
  1. Multidimensional Fatigue Inventory (MFI) [ Time Frame: Through study completion, an average of 3 months ]
    Multidimensional Fatigue Inventory (MFI), a 20-item instrument consisting of several subscales including general fatigue and reduced activity. Severe fatigue it is defined as a score of greater than or equal to 13 on the MFI general fatigue subscale or greater than or equal to 10 on the MFI reduced activity subscale. The mean MFI general fatigue scores ranged from 18.3 to 18.8


Secondary Outcome Measures :
  1. Tampa Scale for Kinesiophobia (TSK-11) [ Time Frame: Through study completion, an average of 3 months ]
    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.

  2. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Through study completion, an average of 3 months ]
    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 HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.

  3. Physical Function of the 36-Item Short Form Survey (SF-36) [ Time Frame: Through study completion, an average of 3 months ]
    Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet the Fukuda and Holmes classification criteria for Fatigue Syndrome Chronicle
  • Age equal to or greater than 18 years
  • Understand and agree to participate in the study
  • Sign the informed consent

Exclusion Criteria:

  • Terminal clinical conditions or scheduled treatments that may interrupt the study follow-up.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593225


Locations
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Spain
Vall d'Hebrón Hospital
Barcelona, Spain, 08023
Vall d'Hebrón Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Mayte Serrat, MSc Vall d'Hebrón Hospital
More Information
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04593225    
Other Study ID Numbers: PR(AG)490/2020
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: December 30, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
multicomponent treatment
Chronic Fatigue Syndrome
pain neuroscience education
therapeutic exercise
 cognitive behavioural therapy
mindfulness
randomized controlled trial
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Virus Diseases
Infections
 Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases