Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia

NCT07661745 | Completed

• 1 other identifier: FibroCatCentral-23/199-P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and psychological symptoms that significantly affect quality of life. This quasi-experimental study aims to evaluate the effectiveness of the FIBROCatCentral interdisciplinary program in improving health-related quality of life among adults with fibromyalgia receiving care in Primary Care centers in Central Catalonia, Spain. Participants in the intervention group will attend a structured multidisciplinary program consisting of 24 sessions delivered by healthcare professionals from different disciplines, including nursing, medicine, physiotherapy, nutrition, mental health, social work, and pharmacy. Outcomes will be assessed at baseline and at 3, 6, and 12 months. The primary outcome is health-related quality of life measured using the EuroQol-5D questionnaire. Secondary outcomes include fibromyalgia impact, depressive symptoms, treatment adherence, participant satisfaction, and changes in pharmacological treatment.

Conditions

Fibromyalgia (FM)

Keywords

Fibromyalgia; Primary Care; Quality of Life; Health Promotion; Chronic Pain; Depression; Multidisciplinary Intervention

Outcome Measures

Primary Outcomes (3)

• Fibromyalgia Impact

  Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R).

  Baseline, 3 months, 6 months, and 12 months

• Health-Related Quality of Life

  Health-related quality of life assessed using the EuroQol-5D (EQ-5D) questionnaire.

  Baseline, 3 months, 6 months, and 12 months

• Depressive Symptoms

  Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).

  Baseline, 3 months, 6 months, and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive the FIBROCatCentral interdisciplinary program consisting of 24 one-hour sessions delivered by an interdisciplinary team including nurses, physicians, physiotherapists, emotional well-being professionals, nutritionists, social workers, and pharmacists. The program combines educational and practical activities aimed at improving symptom self-management, quality of life, and overall well-being.

Behavioral: FIBROCatCentral Multidisciplinary Intervention Program

Control

NO INTERVENTION

Participants will continue receiving usual care in Primary Care, including routine follow-up visits and pharmacological management of symptoms as determined by their healthcare professionals.

Interventions

FIBROCatCentral Multidisciplinary Intervention Program BEHAVIORAL

A 24-session interdisciplinary program for people with fibromyalgia delivered by primary care healthcare professionals, including nurses, physicians, physiotherapists, emotional well-being professionals, nutritionists, social workers, and pharmacists. The intervention combines educational and practical activities aimed at improving symptom self-management, quality of life, and overall well-being.

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of fibromyalgia.
• Age between 18 and 85 years.
• Assigned to a participating Primary Care Center in the Central Catalonia region (Bages, Berguedà, Moianès, or Calaf areas).
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Severe mental illness.
• Current follow-up in a specialized hospital fibromyalgia unit and previous participation in a therapeutic group program for fibromyalgia.
• Inability to complete study questionnaires due to language barriers, illiteracy, or other limitations affecting reading or writing.
• Refusal or inability to provide informed consent.

Sponsors & Collaborators

• Catalan Institute of Health: collaborator
• University of Vic - Central University of Catalonia: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Institut Català de la Salut - Gerència Territorial Catalunya Central

Manresa, Barcelona, 08240, Spain

Location

Related Publications (5)

• Sauch Valmana G, Miro Catalina Q, Carrasco-Querol N, Vidal-Alaball J. Gender, Mental Health and Socioeconomic Differences in Fibromyalgia: A Retrospective Cohort Study Using Real-World Data from Catalonia. Healthcare (Basel). 2023 Feb 10;11(4):530. doi: 10.3390/healthcare11040530.

  PMID: 36833067 BACKGROUND

• Serrat M, Almirall M, Muste M, Sanabria-Mazo JP, Feliu-Soler A, Mendez-Ulrich JL, Luciano JV, Sanz A. Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Oct 18;9(10):3348. doi: 10.3390/jcm9103348.

  PMID: 33081069 BACKGROUND

• Ollevier A, Vanneuville I, Carron P, Baetens T, Goderis T, Gabriel L, Van de Velde D. A 12-week multicomponent therapy in fibromyalgia improves health but not in concomitant moderate depression, an exploratory pilot study. Disabil Rehabil. 2020 Jun;42(13):1886-1893. doi: 10.1080/09638288.2018.1543361. Epub 2019 Jan 29.

  PMID: 30696285 BACKGROUND

• Luciano JV, Martinez N, Penarrubia-Maria MT, Fernandez-Vergel R, Garcia-Campayo J, Verduras C, Blanco ME, Jimenez M, Ruiz JM, Lopez del Hoyo Y, Serrano-Blanco A; FibroQoL Study Group. Effectiveness of a psychoeducational treatment program implemented in general practice for fibromyalgia patients: a randomized controlled trial. Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b013e31820b131c.

  PMID: 21317775 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.

  PMID: 27916278 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start: November 15, 2024
• Primary Completion: May 21, 2026
• Study Completion: May 21, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)