Fibromyalgia: Impact of Self-Knowledge on Well-Being

April 2, 2025 updated by: Ana Isabel Ribeiro Cruz, University of Coimbra

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?

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-548
        • Faculdade de Medicina da Universidade de Coimbra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of fibromyalgia
  • Age ≥ 18 years
  • Ability to understand and provide informed consent

Exclusion Criteria:

  • Cognitive impairment that prevents comprehension of the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Knowledge Training Group
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.
Behavioral: Self-Knowledge Training Program
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.
No Intervention: Control Group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after completion of the 10-week intervention
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.
Baseline and after completion of the 10-week intervention
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.
Baseline and after completion of the 10-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Flexibility (Psy-Flex Scale)
Time Frame: Baseline and after completion of the 10-week intervention
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.
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

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.
Baseline and after completion of the 10-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Coimbra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

October 24, 2024

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on Self-Knowledge Training Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe