Effectiveness of VIRTUAL SFCAMINA STUDY

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04593225
• Collaborator: (none)
• Enrollment: 480
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site: 240
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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)	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Assignment Single-blind, parallel-group, randomized controlled trialParallel 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: Apr 21, 2020
• Anticipated Primary Completion Date: Dec 21, 2021
• Anticipated Study Completion Date: Jan 21, 2022

Arms and Interventions

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

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Vall d'Hebrón Hospital	Barcelona		Spain	08023
2	Vall d'Hebrón Hospital	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT04593225
• Other Study ID Numbers: PR(AG)490/2020
• First Posted: Oct 19, 2020
• Last Update Posted: Dec 30, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Fatigue Syndrome, Chronic; Syndrome; Fatigue

Study Results

No Results Posted as of Dec 30, 2021