Effectiveness of VIRTUAL SFCAMINA STUDY

Study Overview
=================
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.

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.

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

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Behavioral: TAU + multicomponent treatment VIRTUAL SFCAMINA
* Behavioral: Treatment as Usual (TAU)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU + multicomponent treatment VIRTUAL SFCAMINA<br>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<br>* 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.<br>|
| Active Comparator: Treatment as Usual (TAU)<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Fatigue Inventory (MFI) | 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) | 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) | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
therapeutic exercise, multicomponent treatment, Chronic Fatigue Syndrome, pain neuroscience education, cognitive behavioural therapy, mindfulness, randomized controlled trial