Prevalence of the Traumatic Events in Women With Fibromyalgia

NCT ID: NCT04476316

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2020-12-31

Brief Summary

Suffering a traumatic event is a potential risk factor for developing Posttraumatic Stress Disorder (PTSD) with or without comorbidities with other pathologies that can become chronic with time, including fibromyalgia. Different study results show the existence of an association between living traumatic events and developing fibromyalgia. However, studies in the field have not evaluated thoroughly the nature of traumatic events, the subsequent development of PTSD and the degree to which it can cause an impairment. These results will allow us increase the knowledge about the effects of comorbidity between both medical conditions, get to know in depth the type of traumatic events that female patients with FM suffer, and express the importance of the implementation of a therapeutic approach which takes into account the existing psychological symptoms in addition to the main principal pathology.

Detailed Description

BACKGROUND:

Fibromyalgia (FM) affects 2-4% of the general population with typical symptoms being generalized and widespread pain, sleep disturbances, problems in memory and attention, anxiety and depression. Different studies have demonstrated a clear relationship between the presence of psychological trauma and FM, in terms of sexual and physical abuse, chronic stress and adverse lifetime events. According to some studies, the prevalence of Posttraumatic Stress Disorder (PTSD) in patients with FM is 45,3%, while in the general population it appears to be between 1.3%-12.3%. Nevertheless, current therapeutic approaches do not take into account the assessment and treatment of this risk factor, therefore the clinical benefits obtained are limited. Moreover, existing studies in the field do not carry out a thorough clinical characterization of these traumatic events. As a result, there is a lack of consensus about the prevalence of the different types of traumatic events and their temporality, as well as a lack of awareness of the level of interference and impairment in patients with FM. Additionally, studies done on the topic are subject to important methodological biases.

JUSTIFICATION OF THE STUDY:

Due to everything explained above, we consider that studying the prevalence and clinical characteristics of the possible traumatic events in patients with FM has a great relevance and clinical importance, due to the considerable negative impact they have across the beginning, curse and prognosis of this disease.

AIMS:

The main objective of the project is to study de prevalence and characterization of traumatic events in a sample of women diagnosed with FM and their association with FM's clinical severity.

Specifically, the study intends to analyze the existence of specific characteristics of traumatic events, such as the age when the event was experienced, the type of trauma (interpersonal o intrapersonal; simple or complex; single or repeated in time, etc.) that can be predictors or explicative of the patterns presented by these patients.

HYPOTHESIS:

1. Participants who have suffered traumatic events during childhood, of the interpersonal type and repeated in time will be associated with greater severity of FM and higher levels of pain.

2. Participants who have suffered traumatic events during childhood, of the interpersonal type and repeated in time will present greater severity in the clinical symptoms of trauma.

3. Participants who have suffered traumatic events during childhood, of the interpersonal type and repeated in time will present higher severity in affective symptoms, sleep disturbances and quality of life.

STUDY DESIGN:

This is a transversal descriptive study in which the Rheumatology Service, Adult Mental Health Service and Primary Care Centers of the Parc de Salut Mar will participate. The evaluations will be carried out in a single interview with the duration of 1 hour and a half, and will be conducted by specialized psychologists of the Centre Forum Research Unit (IMIM). Participants will have the choice to attend the assessment in the Centre Forum C/Llull 410, 08019) or in the Rheumatology Service (CAP Vila Olímpica, C/Joan Miró 17, 08005) of the Parc de Salut Mar.

During assessment sociodemographic, clinical and pharmacological data will be collected. Additionally, through the use of evaluation scales, pain and FM impact, psychological trauma related symptoms, clinical symptoms, insomnia and quality of life will be evaluated.

STATISTICAL ANALYSIS:

The data analysis will be carried out using the R statistics package. Logic, range and data consistency tests will be applied to clean the data. In the same way, the different distributions of the variables will be obtained in order to facilitate the detection of possible errors in the data entry.

Descriptive analysis will be carried out of all the identified variables in the study. Likewise, regression analysis will be used to predict the pain severity index (EVA, PDI, FIQ) based on trauma-related variables (CTQ, IES-R, SUD, DES, SDQ-20), and to predict the clinical severity index (HADS, AIS, SWLS) based on the pain-related variables (EVA, PDI, FIQ). Redundant variables will be eliminated from the model in order to identify the smallest possible group of predictors to explain a substantial amount of the variation in the dependent variables.

To control a possible confusion bias, an adjustment model will be defined to study the influence of other variables and analyse possible confounders.

A general lineal model will be used for independent variables of more than 2 categories and two sample t-tests will be used for variables of 2 categories. Where data does not meet criteria for parametric tests, non parametric tests will be used.

Conditions

Fibromyalgia; Psychological Trauma; Pain; Anxiety; Depression; Sleep Disturbance; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Women with FM diagnosis.
• Age between 18-70.

Exclusion Criteria

• Comorbid autoimmune or chronic inflammatory disease.
• Neurological or serious medical diseases.
• Severe mental health disorders such as bipolar disorder, schizoaffective disorder and/or schizophrenia.
• Active suicidal ideation.
• Substance abuse/dependence within 1 month prior to participation (except for nicotine abuse/dependency).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Ana Moreno Alcázar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Moreno-Alcázar, PhD.

Role: PRINCIPAL_INVESTIGATOR

IMIM

Locations

Parc Salut Mar

Barcelona, , Spain

Countries

Spain

References

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Related Links

https://www.scirp.org/(S(lz5mqp453edsnp55rrgjct55))/reference/ReferencesPapers.aspx?ReferenceID=2041144

Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates, Publishers.

https://www.psicoterapiarelacional.es/Portals/0/eJournalCeIR/V4N3_2010/04_JJMtnez-Iba%C2%A4ez_Repensando-Trauma_CeIR_V4N3.pdf?ver=2010-10-31-020500-000

Martínez Ibáñez, J. J. (2010). Repensando el concepto de trauma. Una redefinición desde los aportes del psicoanálisis relacional. Clínica e Investigación Relacional, 4(3), 1-20.

Other Identifiers

2020/9158

Identifier Type: -

Identifier Source: org_study_id