Effectiveness of VIRTUAL SFCAMINA STUDY

NCT04593225 | Unknown

• 1 other identifier: PR(AG)490/2020
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Fatigue Syndrome

Keywords

multicomponent treatment; Chronic Fatigue Syndrome; pain neuroscience education; therapeutic exercise; cognitive behavioural therapy; mindfulness; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tampa Scale for Kinesiophobia (TSK-11)

  Through study completion, an average of 3 months

• Hospital Anxiety and Depression Scale (HADS)

  Through study completion, an average of 3 months

• Physical Function of the 36-Item Short Form Survey (SF-36)

  Through study completion, an average of 3 months

Study Arms (2)

TAU + multicomponent treatment VIRTUAL SFCAMINA

EXPERIMENTAL

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

TAU + multicomponent treatment VIRTUAL SFCAMINA BEHAVIORAL

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.

TAU + multicomponent treatment VIRTUAL SFCAMINA

Treatment as Usual (TAU) BEHAVIORAL

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Terminal clinical conditions or scheduled treatments that may interrupt the study follow-up.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (2)

Vall d'Hebrón Hospital

Barcelona, 08023, Spain

Location

Vall d'Hebrón Hospital

Barcelona, 08035, Spain

Location

Related Publications (1)

• Serrat M, Navarrete J, Ferres S, Auer W, Sanmartin-Sentanes R, Nieto R, Neblett R, Borras X, Luciano JV, Feliu-Soler A. Effectiveness of an online multicomponent program (FATIGUEWALK) for chronic fatigue syndrome: A randomized controlled trial. Health Psychol. 2024 Apr;43(4):310-322. doi: 10.1037/hea0001346. Epub 2023 Dec 21.

  PMID: 38127508 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mayte Serrat, MSc

  Vall d'Hebrón Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Single-blind, parallel-group, randomized controlled trial

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: April 21, 2020
• Primary Completion: December 21, 2021
• Study Completion: January 21, 2022
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)