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NCT Number: NCT06912971

Fibromyalgia: Impact of Self-Knowledge on Well-Being

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Medicina da Universidade de Coimbra

Coimbra, 3000-548, Portugal

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Self-Knowledge Training Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

Fibromyalgia: The Impact of Self-Knowledge on the Well-Being of People With Fibromyalgia

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

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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