Evaluation of the Effectiveness of a Psychological Intervention for Fibromyalgia Supported by New Technologies

NCT07347704 | Completed

• 1 other identifier: FIBROEMA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the feasibility of a psychological intervention in patients diagnosed with Fibromyalgia supported by new technologies.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• App' usability and acceptability

  The System Usability Scale will be used to evaluate the perception that this tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree").

  One administration one week after downloading the app

• Feasibility of the app

  Feasibility of the study will be assessed by a calculation of responses completed from the assessments prompted.

  At the end of the study (9 weeks after study onset)

Secondary Outcomes (4)

• Changes in the Fibromyalgia Impact Questionnaire

  Changes from Pretreatment to Posttreatment (9 weeks after study onset)

• Changes in the Chronic Pain Coping Inventory-42

  Changes from Pretreatment to Posttreatment (9 weeks after study onset)

• Changes in the Survey of Pain Attitudes

  Changes from Pretreatment to Posttreatment (9 weeks after study onset)

• Changes in the Beck Depression Inventory

  Changes from Pretreatment to Posttreatment (9 weeks after study onset)

Study Arms (1)

Cognitive Behavioral Therapy with app support

EXPERIMENTAL

A group intervention with a cognitive-behavioral approach of 8 sessions will be carried out. The intervention will focus on learning about the modulating factors of the pain experience and the acquisition of tools related to each of these factors.

Device: Cognitive Behavioral Therapy with app suport

Interventions

Cognitive Behavioral Therapy with app suport DEVICE

Psychotherapy based on Cognitive Behavioral Therapy principles supported with technology to receive notifications about the evolution of the participants during therapy

Cognitive Behavioral Therapy with app support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with fibromyalgia

You may not qualify if:

• Does not have a smartphone

Sponsors & Collaborators

• Universitat Jaume I: lead
• Hospital Provincial de Castellon: collaborator

Study Sites (1)

Hospital Provincial

Castellon, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We have included more participants than 20 because similar studies have recommended larger sample sizes for feasibility trials similar to ours

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: January 16, 2026
• Study Start: November 30, 2022
• Primary Completion: April 25, 2023
• Study Completion: April 30, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)