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

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Cognitive Behavioral Therapy with app suport

Detailed Description

Different therapeutic options for psychological intervention in fibromyalgia are currently available. However, these interventions are usually of a general nature and do not take into account the differences between patients.

On the other hand, we know that these programs have greater or lesser effectiveness in improving quality of life and adaptation to pain, but there is not as much information available regarding the therapeutic mechanisms that are related to this effectiveness, i.e., What variables mediate the improvement in therapy? When do they produce the change? Is it possible to adapt the interventions to the results of the same that we can receive in real time? In the present work we propose to apply a psychological treatment already validated for fibromyalgia emphasizing those variables of beliefs and coping that research has shown to be directly related to belonging to the group of higher or lower functionality.

The objective will be to find out, on the one hand, if it is feasible to monitor the change in therapy using new technologies and, on the other hand, to measure this change to consider it when implementing the intervention, which is traditionally quite manualized when performed at group level and hardly considers individual differences in the response to treatment during treatment. Specifically, by means of a validated App we will measure those therapeutic variables that we expect to change as a result of introducing the treatment and, if not, a series of alarms will be generated that will alert the clinician of the absence of the expected change so that he can adapt the intervention according to the evolution of the patient in real time.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castellon, Spain
    • Hospital Provincial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with fibromyalgia

Exclusion Criteria:

• Does not have a smartphone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy with app support; 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; Psychotherapy based on Cognitive Behavioral Therapy principles supported with technology to receive notifications about the evolution of the participants during therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Fibromyalgia Impact Questionnaire	Evaluates impact of fibromyalgia on functioning. It includes 20 items with a response range from 0 to 10. Higher scores reflect greater impact of the disease.	Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Changes in the Chronic Pain Coping Inventory-42	Evaluates coping strategies used to deal with pain. It includes 42 items scored from 0 days to 7 days depending on the number of days each coping strategy is used. Higher score means more frequent use of the strategy in the past week.	Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Changes in the Survey of Pain Attitudes	Evaluates beliefs about pain. It includes 25 items. Respondents are asked to indicate their degree of agreement using a 5-point Likert scale ranging from 0 (very false for me) to 4 (very true for me). A higher score on a subscale implies a greater degree of certainty about the corresponding belief or pain-related attitude.	Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Changes in the Beck Depression Inventory	Evaluates the severity of depression symptoms. It includes 21 items with a response range from 0 to 63. Higher scores reflect more severe depressive symptoms.	Changes from Pretreatment to Posttreatment (9 weeks after study onset)

Collaborators and Investigators

• Sponsor: Universitat Jaume I
• Collaborators: Hospital Provincial de Castellon

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: FIBROEMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No