Effectiveness of VIRTUAL SFCAMINA STUDY

Not Applicable

• Conditions: Chronic Fatigue Syndrome
• Interventions: Behavioral: TAU + multicomponent treatment VIRTUAL SFCAMINA; Behavioral: Treatment as Usual (TAU)

• Registration Number: NCT04593225
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2020-04-21
• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-19
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Primary Completion: 2021-12-21
• Last Update Posted: 2021-12-30
• Study Completion: 2022-01-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU + multicomponent treatment VIRTUAL SFCAMINA	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
Treatment as Usual (TAU)	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

Primary Outcome Measures

Name	Time	Method
Multidimensional Fatigue Inventory (MFI)	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

Name	Time	Method
Tampa Scale for Kinesiophobia (TSK-11)	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.
Physical Function of the 36-Item Short Form Survey (SF-36)	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.
Hospital Anxiety and Depression Scale (HADS)	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.

Trial Locations

Locations (1)

Vall d'Hebrón Hospital; 🇪🇸 Barcelona, Spain