FibromyalgiaNCT07347704
Evaluation of the Effectiveness of a Psychological Intervention for Fibromyalgia Supported by New Technologies
A study testing Cognitive Behavioral Therapy with app suport in people with Fibromyalgia, run by Universitat Jaume I at 1 site in Spain.
Trial summary
This study aims to evaluate the feasibility of a psychological intervention in patients diagnosed with Fibromyalgia supported by new technologies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cognitive Behavioral Therapy with app suport
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with fibromyalgia
Who cannot join
- Does not have a smartphone
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the feasibility of a psychological intervention in patients diagnosed with Fibromyalgia supported by new technologies.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Cognitive Behavioral Therapy with app suport
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy with app suportDevice
Psychotherapy based on Cognitive Behavioral Therapy principles supported with technology to receive notifications about the evolution of the participants during therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cognitive Behavioral Therapy with app suport |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: At the end of the study (9 weeks after study onset)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Nov 2022
- Primary completion25 Apr 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We have included more participants than 20 because similar studies have recommended larger sample sizes for feasibility trials similar to ours
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Provincial de Castellon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347704
- Sponsor's protocol ID
- FIBROEMA
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2021
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Psychological Intervention for Fibromyalgia Supported by New Technologies
- ClinicalTrials.gov ID
- NCT07347704
- Acronym / sponsor ID
- FIBROEMA
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Hospital Provincial de Castellon
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the feasibility of a psychological intervention in patients diagnosed with Fibromyalgia supported by new technologies.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We have included more participants than 20 because similar studies have recommended larger sample sizes for feasibility trials similar to ours
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy with app support | Experimental | Device: Cognitive Behavioral Therapy with app suportA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with fibromyalgia
Key exclusion criteria (1 listed)
- Does not have a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy with app suportPsychotherapy based on Cognitive Behavioral Therapy principles supported with technology to receive notifications about the evolution of the participants during therapy | Device | Cognitive Behavioral Therapy with app support |
Primary outcome
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").
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.
4 secondary outcomes
Changes in the Fibromyalgia Impact Questionnaire
Time frame: Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Changes in the Chronic Pain Coping Inventory-42
Time frame: Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Changes in the Survey of Pain Attitudes
Time frame: Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Changes in the Beck Depression Inventory
Time frame: Changes from Pretreatment to Posttreatment (9 weeks after study onset)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy with app suport in people with Fibromyalgia, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App' usability and acceptability (time frame: One administration one week after downloading the app). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.