Effectiveness of VIRTUAL SFCAMINA STUDY

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Chronic Fatigue Syndrome

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: TAU + multicomponent treatment VIRTUAL SFCAMINA

Study type: Interventional

Funder types: Other

Identifiers

NCT04593225

PR(AG)490/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

480 participants in 2 patient groups

TAU + multicomponent treatment VIRTUAL SFCAMINA

Experimental group

Description:

VIRTUAL SFCAMINA is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training

Treatment:

Behavioral: TAU + multicomponent treatment VIRTUAL SFCAMINA

Treatment as Usual (TAU)

Active Comparator group

Description:

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

Treatment:

Behavioral: Treatment as Usual (TAU)