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

NCT ID: NCT07347704

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

We have included more participants than 20 because similar studies have recommended larger sample sizes for feasibility trials similar to ours
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy with app suport

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with fibromyalgia

Exclusion Criteria

* Does not have a smartphone
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Provincial de Castellon

OTHER

Sponsor Role collaborator

Universitat Jaume I

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Provincial

Castellon, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FIBROEMA

Identifier Type: -

Identifier Source: org_study_id

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