Fibromyalgia: Impact of Self-Knowledge on Well-Being

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT06912971
• Lead Sponsor: University of Coimbra

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-18
• Primary Completion: 2024-07-31
• Study Completion: 2024-10-24
• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of Life (EQ-5D-3L)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Psychological Flexibility (Psy-Flex Scale)	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.
Self-Reflection and Insight (SRIS Scale)	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.

Trial Locations

Locations (1)

Faculdade de Medicina da Universidade de Coimbra; 🇵🇹 Coimbra, Portugal