Effectiveness of VIRTUAL SFCAMINA STUDY (SFCAMINA)

December 9, 2021 updated by: Hospital Universitari Vall d'Hebron Research Institute

Effectiveness of Virtual Multicomponent Treatment for Chronic Fatigue Syndrome: VIRTUAL SFCAMINA STUDY

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Vall d'Hebron Hospital
      • Barcelona, Spain, 08023
        • Vall d'Hebron Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 months
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.
Through study completion, an average of 3 months
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.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Mayte Serrat, MSc, Vall d'Hebron Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Anticipated)

December 21, 2021

Study Completion (Anticipated)

January 21, 2022

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

December 30, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)490/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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