FibromyalgiaNCT06912971
Fibromyalgia: Impact of Self-Knowledge on Well-Being
A study testing Self-Knowledge Training Program in people with Fibromyalgia, run by University of Coimbra at 1 site in Portugal.
Trial summary
The goal of this observational study is to evaluate the impact of self-knowledge training on the well-being of individuals with fibromyalgia. The main questions it aims to answer are: Does self-knowledge training improve participants' perceived quality of life? Does self-knowledge training influence the way… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Self-Knowledge Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Jun 2024to 24 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia
- Age ≥ 18 years
- Ability to understand and provide informed consent
Who cannot join
- Cognitive impairment that prevents comprehension of the intervention
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Medicina da Universidade de Coimbra
Coimbra, 3000-548
About this study
Official title: Fibromyalgia: The Impact of Self-Knowledge on the Well-Being of People With Fibromyalgia
The goal of this observational study is to evaluate the impact of self-knowledge training on the well-being of individuals with fibromyalgia. The main questions it aims to answer are:
Does self-knowledge training improve participants' perceived quality of life?
Read more
Does self-knowledge training influence the way participants manage their fibromyalgia symptoms?
Participants will:
Take part in a structured self-knowledge intervention based on the Enneagram framework.
Complete validated questionnaires before and after the intervention to assess their well-being.
Provide qualitative feedback on their experience with the training.
This study will help understand whether self-awareness strategies can be integrated into non-pharmacological approaches for fibromyalgia management.
- Conditions
- Fibromyalgia
- Being tested
- Self-Knowledge Training Program
- Keywords
- Fibromyalgia, self-knowledge, quality of life, Enneagram
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Knowledge Training ProgramBehavioural
The intervention consists of a self-knowledge training program based on the Enneagram framework. Participants attend 7 sessions, focusing on self-awareness, emotional regulation, and personal development. The sessions include theoretical explanations, guided self-reflection exercises, and group discussions to help participants better understand their personality patterns and how these influence their perception of pain and well-being.
| Study group | Role | What they receive |
|---|---|---|
| Self-Knowledge Training Group | Experimental | Participants in this group will undergo a self-knowledge training program based on the Enneagram framework. The program consists of 2 sessions, focusing on self-awareness, emotional regulation, and personal growth. Receives: Behavioral: Self-Knowledge Training Program |
| Control Group | No intervention | Participants in this group will not receive any self-knowledge training during the study period. They will continue with their usual care and will be assessed at the same time points as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (EQ-5D-3L)
The EQ-5D-3L is a generic instrument for assessing health-related quality of life (HRQoL), comprising five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 3-level scale (1 = no problems, 2 = moderate problems, 3 = severe problems). The responses generate a health index, where higher scores indicate worse quality of life.
Measured: Baseline and after completion of the 10-week intervention
Perceived Quality of Life (EQ-VAS)
The EQ-VAS is a visual analogue scale measuring self-perceived health status. Participants rate their health on a 0-100 scale (0 = worst imaginable health state, 100 = best imaginable health state). Higher scores indicate better perceived quality of life.
Measured: Baseline and after completion of the 10-week intervention
Mental Health - Depression, Anxiety, and Stress (DASS-21)
The DASS-21 is a 21-item questionnaire assessing symptoms of depression, anxiety, and stress. It includes three subscales (7 items each), rated on a 0-3 scale (0 = does not apply at all, 3 = applies very much or most of the time). Higher scores indicate greater severity of symptoms.
Measured: Baseline and after completion of the 10-week intervention
Secondary outcomes (2)
Psychological Flexibility (Psy-Flex Scale)
The Psy-Flex Scale assesses psychological flexibility, a core construct in Acceptance and Commitment Therapy (ACT). It consists of six items, each representing a fundamental process of psychological flexibility. Responses are rated on a 5-point Likert scale (1 = very rarely, 5 = very frequently). Higher scores indicate greater psychological flexibility.
Measured: Baseline and after completion of the 10-week intervention
Self-Reflection and Insight (SRIS Scale)
The Self-Reflection and Insight Scale (SRIS) evaluates self-reflection and insight through three subscales:
Engagement in Self-Reflection: Assesses the depth of cognitive and emotional self-examination.
Need for Self-Reflection: Measures the individual's motivation for self-reflection.
Insight: Evaluates the individual's level of self-awareness and understanding.
Each item is rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores indicate greater self-reflection and insight.
Measured: Baseline and after completion of the 10-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start18 Jun 2024
- Primary completion31 Jul 2024
- Study completion24 Oct 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Isabel Ribeiro Cruz, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912971
- Sponsor's protocol ID
- 10-2024
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding the sharing of individual participant data has not been finalized. Any future data sharing will be subject to ethical review and compliance with data protection guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia: The Impact of Self-Knowledge on the Well-Being of People With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06912971
- Acronym / sponsor ID
- 10-2024
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, self-knowledge, quality of life, Enneagram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 6 Apr 2025 (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.
The goal of this observational study is to evaluate the impact of self-knowledge training on the well-being of individuals with fibromyalgia. The main questions it aims to answer are:
Does self-knowledge training improve participants' perceived quality of life?
Does self-knowledge training influence the way participants manage their fibromyalgia symptoms?
Participants will:
Take part in a structured self-knowledge intervention based on the Enneagram framework.
Complete validated questionnaires before and after the intervention to assess their well-being.
Provide qualitative feedback on their experience with the training.
This study will help understand whether self-awareness strategies can be integrated into non-pharmacological approaches for fibromyalgia management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Knowledge Training Group | Experimental | Behavioral: Self-Knowledge Training ProgramParticipants in this group will undergo a self-knowledge training program based on the Enneagram framework. The program consists of 2 sessions, focusing on self-awareness, emotional regulation, and personal growth. |
| Control Group | No intervention | –Participants in this group will not receive any self-knowledge training during the study period. They will continue with their usual care and will be assessed at the same time points as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of fibromyalgia
- Age ≥ 18 years
- Ability to understand and provide informed consent
Key exclusion criteria (1 listed)
- Cognitive impairment that prevents comprehension of the intervention
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 |
|---|---|---|
| Self-Knowledge Training ProgramThe intervention consists of a self-knowledge training program based on the Enneagram framework. Participants attend 7 sessions, focusing on self-awareness, emotional regulation, and personal development. The sessions include theoretical explanations, guided self-reflection exercises, and group discussions to help participants better understand their personality patterns and how these influence their perception of pain and well-being. | Behavioural | Self-Knowledge Training Group |
Primary outcome
Quality of Life (EQ-5D-3L)
Time frame: Baseline and after completion of the 10-week intervention
The EQ-5D-3L is a generic instrument for assessing health-related quality of life (HRQoL), comprising five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 3-level scale (1 = no problems, 2 = moderate problems, 3 = severe problems). The responses generate a health index, where higher scores indicate worse quality of life.
Perceived Quality of Life (EQ-VAS)
Time frame: Baseline and after completion of the 10-week intervention
The EQ-VAS is a visual analogue scale measuring self-perceived health status. Participants rate their health on a 0-100 scale (0 = worst imaginable health state, 100 = best imaginable health state). Higher scores indicate better perceived quality of life.
Mental Health - Depression, Anxiety, and Stress (DASS-21)
Time frame: Baseline and after completion of the 10-week intervention
The DASS-21 is a 21-item questionnaire assessing symptoms of depression, anxiety, and stress. It includes three subscales (7 items each), rated on a 0-3 scale (0 = does not apply at all, 3 = applies very much or most of the time). Higher scores indicate greater severity of symptoms.
2 secondary outcomes
Psychological Flexibility (Psy-Flex Scale)
Time frame: Baseline and after completion of the 10-week intervention
Self-Reflection and Insight (SRIS Scale)
Time frame: Baseline and after completion of the 10-week intervention
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 6 Apr 2025.
- Individual participant dataSharing planned: Undecided. The decision regarding the sharing of individual participant data has not been finalized. Any future data sharing will be subject to ethical review and compliance with data protection guidelines.
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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 Self-Knowledge Training Program in people with Fibromyalgia, run by University of Coimbra at 1 site in Portugal.
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 3 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 6 Apr 2025. 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 Portugal. 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?
Quality of Life (EQ-5D-3L) (time frame: Baseline and after completion of the 10-week intervention). The study lists 3 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 6 Apr 2025.