Fibromyalgia: Impact of Self-Knowledge on Well-Being

NCT06912971 | Completed

• 1 other identifier: 10-2024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; self-knowledge; quality of life; Enneagram

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and after completion of the 10-week intervention

Secondary Outcomes (2)

• Psychological Flexibility (Psy-Flex Scale)

  Baseline and after completion of the 10-week intervention

• Self-Reflection and Insight (SRIS Scale)

  Baseline and after completion of the 10-week intervention

Study Arms (2)

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.

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.

Interventions

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.

Self-Knowledge Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment that prevents comprehension of the intervention

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Faculdade de Medicina da Universidade de Coimbra

Coimbra, 3000-548, Portugal

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ANA ISABEL RIBEIRO CRUZ

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 6, 2025
• Study Start: June 18, 2024
• Primary Completion: July 31, 2024
• Study Completion: October 24, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-03

Locations

PT (1)