Effectiveness of Experiential Fibrowalk Therapy

NCT06457633 | Active Not Recruiting

• 1 other identifier: Experiential Fibrowalk
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The present project will evaluate through a randomised controlled clinical trial with 4-month follow-up, the efficacy in clinical symptoms and quality of life (3-month time horizon) of the multicomponent EXPERIENTIAL FIBROWALK programme in treating individuals diagnosed with fibromyalgia, in compare with original Fibrowalk and virtual Fibrowalk. Pre-post changes will be evaluated in various variables under investigation, will include kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity. The design of the present study with 3 treatment branches: Condition or disease Fibromyalgia Intervention/treatment Behavioral: TAU + Experiential Fibrowalk Behavioral: TAU + Fibrowalk Behavioral: TAU + virtual

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Multicomponent Treatment; Nature therapy; Mindfulness; Physical therapy; Pain Science Education (PSE); Psychological Approach; Experiential Therapy

Outcome Measures

Primary Outcomes (1)

• Revised Fibromyalgia Impact Questionnaire (FIQR)

  Standard pharmacological treatment usually provided to patients with fibromyalgia. The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.

  Change from baseline values at 3 months

Secondary Outcomes (11)

• Hospital Anxiety and Depression Scale (HADS)

  Change from baseline values at 3 months

• Short Form-36 Health Survey (SF-36)

  Change from baseline values at 3 months

• Tampa Scale for kinesiophobia (TSK-11)

  Change from baseline values at 3 months

• Multidimensional Fatigue Inventory (MFI)

  Change from baseline values at 3 months

• Pain Catastrophising Scale (PCS)

  Change from baseline values at 3 months

Study Arms (3)

Experiential FW

EXPERIMENTAL

Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) based in no-responder predictive analysis and co-creating process

Behavioral: Experiential FW

Traditional FW

ACTIVE COMPARATOR

Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention)

Behavioral: Traditional FW

Online FW

ACTIVE COMPARATOR

Group treatment protocol of 12 weekly 60 minute sessions (virtual intervention)

Behavioral: Online FW

Interventions

Experiential FW BEHAVIORAL

Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.) carried out experientially.

Experiential FW

Traditional FW BEHAVIORAL

Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.)

Traditional FW

Online FW BEHAVIORAL

Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.) performed virtually.

Online FW

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults from 18 to 75 years-old.
• American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
• Able to understand Spanish and accept to participate in the study.

You may not qualify if:

• Participating in concurrent or past RCTs (previous year).
• Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron Research Institute

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Albert Feliu, PhD

  Universitat Autonoma de Barcelona

  STUDY CHAIR

Study Design

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

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

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: May 9, 2024
• Primary Completion: July 30, 2024
• Study Completion: October 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)