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Completed

NCT Number: NCT07347704

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Provincial

Castellon, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with fibromyalgia

Exclusion criteria

  • Does not have a smartphone

Treatment and study plan

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

Primary outcomes

  1. App' usability and acceptability

    Time frame: One administration one week after downloading the app

    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").

  2. Feasibility of the app

    Time frame: At the end of the study (9 weeks after study onset)

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

Secondary outcomes

  1. Changes in the Fibromyalgia Impact Questionnaire

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

    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.

  2. Changes in the Chronic Pain Coping Inventory-42

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

    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.

  3. Changes in the Survey of Pain Attitudes

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

    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.

  4. Changes in the Beck Depression Inventory

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

    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.

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Collaborators

  • Hospital Provincial de Castellon

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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