Effectiveness of Experiential Fibrowalk Therapy
NCT Number: NCT06457633
Acronym: EFW
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: BEHAVIORAL: Experiential FW|BEHAVIORAL: Traditional FW|BEHAVIORAL: Online FW
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Collaborators: Universitat Autonoma de Barcelona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-09
Completion Date: 2024-10-30
Locations: Hospital Universitari Vall d'Hebron Research Institute, Barcelona, 08035, Spain

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

Primary Outcome Measures: 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 Outcome Measures: 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, Change from baseline values at 3 months|Short Form-36 Health 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., Change from baseline values at 3 months|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., Change from baseline values at 3 months|Multidimensional Fatigue Inventory (MFI), Change from baseline values at 6 months\] MFI is used to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Its consists in a 20-item scale designed. Participants utilize a 7-point scale to express the extent to which specific statements accurately reflect their fatigue experiences. Several positively phrased items are reverse-scored. Greater overall scores indicate higher levels of fatigue severity., Change from baseline values at 3 months|Pain Catastrophising Scale (PCS), PCS is used to evaluate catastrophic thoughts associated with pain. It consists of three dimensions (rumination, magnification, and helplessness) of 13 items in total, which are answered on a Likert scale of 5 points. Total scores on each scale range from 0 to 52, with higher scores indicating more catastrophic thoughts, Change from baseline values at 3 months|Psychological inflexibility in pain scale (PIPS), A 12-item scale that assesses psychological inflexibility in pain patients and includes two factors: avoidance and cognitive fusion with pain. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). Higher scores indicate greater levels of psychological inflexibility., Change from baseline values at 3 months|The Patient Global Impression of Change (PGIC), Is a measure that has been frequently used as indicators of meaningful overall change \[on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"\] in treatments for chronic pain., Change from baseline values at 3 months|Pain Specific Impression of Change (PSIC), The PSIC asks about the impression of change in more specific domains than PGIC: physical and social functioning, work-related activities, mood, and pain \[on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"\]., Change from baseline values at 3 months|Credibility/Expectancy Questionnaire (CEQ) (Adapted version), This is a 6-item test used to assess treatment expectations (3 items) as well as credibility (3 items). After the treatment, the test is administered with the questions reformulated in the past tense., Change from baseline values at 3 months|Adverse effects of treatments, Ad hoc measure to check for the presence of negative effects of psychological treatments., Change from baseline values at 3 months|Socio-demographic questionnaire, Gender, date of birth, marital status, living arrangements, educational level and employment status., Change from baseline values at 3 months