Back to resultsEffectiveness of VIRTUAL SFCAMINA STUDY (SFCAMINA)
Primary Purpose
Chronic Fatigue Syndrome
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAU + multicomponent treatment VIRTUAL SFCAMINA
Treatment as Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring multicomponent treatment, Chronic Fatigue Syndrome, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial
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.
Sites / Locations
- Vall d'Hebrón Hospital
- Vall d'Hebrón Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TAU + multicomponent treatment VIRTUAL SFCAMINA
Treatment as Usual (TAU)
Arm 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-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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04593225
First Posted
October 13, 2020
Last Updated
December 9, 2021
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04593225
Brief Title
Effectiveness of VIRTUAL SFCAMINA STUDY
Acronym
SFCAMINA
Official Title
Effectiveness of Virtual Multicomponent Treatment for Chronic Fatigue Syndrome: VIRTUAL SFCAMINA STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
December 21, 2021 (Anticipated)
Study Completion Date
January 21, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
multicomponent treatment, Chronic Fatigue Syndrome, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAU + multicomponent treatment VIRTUAL SFCAMINA
Arm Type
Experimental
Arm Description
VIRTUAL SFCAMINA is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
TAU + multicomponent treatment VIRTUAL SFCAMINA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention 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.
Primary Outcome Measure Information:
Title
Multidimensional Fatigue Inventory (MFI)
Description
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
Time Frame
Through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Tampa Scale for Kinesiophobia (TSK-11)
Description
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.
Time Frame
Through study completion, an average of 3 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Through study completion, an average of 3 months
Title
Physical Function of the 36-Item Short Form Survey (SF-36)
Description
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.
Time Frame
Through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayte Serrat, MSc
Organizational Affiliation
Vall d'Hebrón Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vall d'Hebrón Hospital
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Vall d'Hebrón Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of VIRTUAL SFCAMINA STUDY
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