Clinical trial NCT04476316: Prevalence of the Traumatic Events in Women With Fibromyalgia
Official title: Prevalence and Clinical Characterization of Traumatic Events in Women With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Psychological Trauma
Pain
Anxiety
Depression
Sleep Disturbance
Quality of Life
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study sample will consist in 83 patients diagnosed with FM recruited by different services of the Parc de Salut Mar.

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.

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).

Primary outcomes:
measure: Levels of pain assessed with the Visual Analogic Scale Questionnaire (VAS)
timeFrame: 1 week
measure: Levels of pain assessed with the Pain Dissability Index (PDI)
timeFrame: 1 week
measure: Levels of pain assessed with the Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 1 week
measure: Presence of Postraumatic Stress Disorder (PTSD) evaluated with the Evaluación Global de Estrés Postraumático (EGEP-5)
timeFrame: 1 week
measure: Levels of trauma associated symptoms assessed with the Impact of Events Scale-Revised (IES-R)
timeFrame: 1 week
measure: Presence of stressful life events in the last year using Holmes & Rahe Social Readjustment Scale
timeFrame: 1 week
measure: Presence of childhood trauma assessed by Childhood Trauma Quiestionnaire (CTQ)
timeFrame: 1 week
measure: Levels of dissociation evaluated by Dissociative Experiences Scale (DES)
timeFrame: 1 week
measure: Levels of somatoform dissociation assessed by Somatoform Dissociation Questionnaire 20 (SDQ-20)
timeFrame: 1 week
measure: Levels of depressive symptoms assessed by with the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week
measure: Levels of anxious symptoms evaluated with the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week
measure: Presence of psyquiatric comorbid disorders assessed by MINI International Neuropsychiatric Interview
timeFrame: 1 week
measure: Levels of sleep disturbances using Athens Insomnia Scale (AIS)
timeFrame: 1 week
measure: Levels of life satisfaction measured with Satisfaction With Life Questionnaire (SWLS)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc Salut Mar
Study officials:
affiliation: IMIM
name: Ana Moreno-Alcázar, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burke NN, Finn DP, McGuire BE, Roche M. Psychological stress in early life as a predisposing factor for the development of chronic pain: Clinical and preclinical evidence and neurobiological mechanisms. J Neurosci Res. 2017 Jun;95(6):1257-1270. doi: 10.1002/jnr.23802. Epub 2016 Jul 12.
citation: Cabo-Meseguer A, Cerda-Olmedo G, Trillo-Mata JL. Fibromyalgia: Prevalence, epidemiologic profiles and economic costs. Med Clin (Barc). 2017 Nov 22;149(10):441-448. doi: 10.1016/j.medcli.2017.06.008. Epub 2017 Jul 19. English, Spanish.
citation: Collado A, Gomez E, Coscolla R, Sunyol R, Sole E, Rivera J, Altarriba E, Carbonell J, Castells X. Work, family and social environment in patients with Fibromyalgia in Spain: an epidemiological study: EPIFFAC study. BMC Health Serv Res. 2014 Nov 11;14:513. doi: 10.1186/s12913-014-0513-5.
citation: Hauser W, Galek A, Erbsloh-Moller B, Kollner V, Kuhn-Becker H, Langhorst J, Petermann F, Prothmann U, Winkelmann A, Schmutzer G, Brahler E, Glaesmer H. Posttraumatic stress disorder in fibromyalgia syndrome: prevalence, temporal relationship between posttraumatic stress and fibromyalgia symptoms, and impact on clinical outcome. Pain. 2013 Aug;154(8):1216-23. doi: 10.1016/j.pain.2013.03.034. Epub 2013 Apr 2.
citation: Kok T, de Haan H, van der Meer M, Najavits L, de Jong C. Assessing traumatic experiences in screening for PTSD in substance use disorder patients: what is the gain in addition to PTSD symptoms? Psychiatry Res. 2015 Mar 30;226(1):328-32. doi: 10.1016/j.psychres.2015.01.014. Epub 2015 Jan 28.
citation: Morgan B, Wooden S. Diagnosis and Treatment of Common Pain Syndromes and Disorders. Nurs Clin North Am. 2018 Sep;53(3):349-360. doi: 10.1016/j.cnur.2018.04.004.
citation: Yavne Y, Amital D, Watad A, Tiosano S, Amital H. A systematic review of precipitating physical and psychological traumatic events in the development of fibromyalgia. Semin Arthritis Rheum. 2018 Aug;48(1):121-133. doi: 10.1016/j.semarthrit.2017.12.011. Epub 2018 Jan 10.