Prevalence of the Traumatic Events in Women With Fibromyalgia

NCT04476316 | Completed

• 1 other identifier: 2020/9158
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (14)

• Levels of pain assessed with the Visual Analogic Scale Questionnaire (VAS)

  Severity in pain intensity will be assessed with the Visual Analogic Scale (rated in a continuum from 0 to 10).

  1 week

• Levels of pain assessed with the Pain Dissability Index (PDI)

  Severity in pain intensity will be assessed with the Pain Disability Index (7 items rated from 0 to 10, making a total score from 0 to 70).

  1 week

• Levels of pain assessed with the Fibromyalgia Impact Questionnaire (FIQ)

  Severity in pain intensity will be assessed with the Fibromyalgia Impact Questionnaire (the first items is rated from 0 to 4, the second from 0 to 7 and the third from 0 to 5; whereas the other 7 items are rated from 0 to 10, with a cut-off score of 50).

  1 week

• Presence of Postraumatic Stress Disorder (PTSD) evaluated with the Evaluación Global de Estrés Postraumático (EGEP-5)

  Presence of Postraumatic Stress Disorder (PTSD) will be assessed using the EGEP-5, a 55-item clinician-administered scale based on DSM-V criteria. There are three different sections: presence of traumatic events, symptoms and functioning. The scale can determine a diagnosis of PTSD, specifying the presence of dissociative symptoms (depersonalization and derealization) and delayed expression.

  1 week

• Levels of trauma associated symptoms assessed with the Impact of Events Scale-Revised (IES-R)

  Psychological trauma will be evaluated using the Impact of Events Scale-Revised. This scale consists in 22-item to determine frequency and impact of posttraumatic symptoms experienced, with subscales of intrusion, avoidance and hyperarousal, each scored on a 5-point Likert scale, yielding a score for each subscale and a total score. This scale has a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations: 24 or more PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms; 33 and above represents the best cutoff for a probable diagnosis of PTSD; 37 or more this is high enough to suppress your immune system's functioning (even 10 years after an impact event).

  1 week

• Presence of stressful life events in the last year using Holmes & Rahe Social Readjustment Scale

  This scale lists 43 possible stressful life events. Each of them have their respective scores. Global scores under 150 indicate low levels of stress, scores between 150 and 299 indicate a 50% risk of stress-related disorders and scores above 300 represent an 80% risk of suffering from stress.

  1 week

• Presence of childhood trauma assessed by Childhood Trauma Quiestionnaire (CTQ)

  The CTQ is a self-administered scale which includes a 28-item test that measure 5 types of childhood maltreatment: emotional, physical and sexual abuse, and emotional or physical neglect. A 5-point Likert scale is used for the responses which range from never true to very often true (with total scores ranging from 5 to 25). The final scores provide a severity score for each subscale from "none to minimal," "low to moderate," "moderate to severe" and "severe to extreme".

  1 week

• Levels of dissociation evaluated by Dissociative Experiences Scale (DES)

  The DES consists of 28 questions about different experiences related to dissociation, excluding when the subject has been under the effects of any substance. This test is scored by totaling the percentage answered for each question (from 0 to 100) and then dividing by 28. A total score higher than or equal to 30 corresponds with high levels of dissociation.

  1 week

• Levels of somatoform dissociation assessed by Somatoform Dissociation Questionnaire 20 (SDQ-20)

  SDQ-20 is a 20-item self-report questionnaire measuring somatoform dissociation. Items refer to somatic symptoms and then ask if there is a known cause. The items are answered on a 5-point Likert scale and the symptoms with no known cause are summed to achieve the total score.

  1 week

• Levels of depressive symptoms assessed by with the Hospital Anxiety and Depression Scale (HADS)

  Severity of depressive symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.

  1 week

• Levels of anxious symptoms evaluated with the Hospital Anxiety and Depression Scale (HADS)

  Severity of anxious symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.

  1 week

• Presence of psyquiatric comorbid disorders assessed by MINI International Neuropsychiatric Interview

  The MINI brief structured interview explores the principal psychiatric disorders from Axis I of DSM-IV and CIE-10. It is divided in different units and contains precise questions about the psychological problems which require yes/no answers.

  1 week

• Levels of sleep disturbances using Athens Insomnia Scale (AIS)

  The AIS is a self-administered scale based on the ICD-10 criteria for insomnia. It measures sleep difficulties suffered over the previous three nights. It consists of 8 items evaluating sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality, well-being, functioning capacity and sleepiness during the day. It is scored from 0 to 24 and higher scores mean greater difficulties.

  1 week

• Levels of life satisfaction measured with Satisfaction With Life Questionnaire (SWLS)

  The SWLS is a 5-item self-administered scale measuring global cognitive judgment of the satisfaction with one's life. The items can be rated from 1 to 5, and lower scores indicate lower satisfaction.

  1 week

Eligibility Criteria

• Age: 18 Years - 70 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Parc Salut Mar

Barcelona, 08019, Spain

Location

Related Publications (8)

• 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.

  PMID: 27402412 BACKGROUND

• 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.

  PMID: 28734619 BACKGROUND

• 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.

  PMID: 25385047 BACKGROUND

• 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.

  PMID: 23685006 BACKGROUND

• 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.

  PMID: 25687377 BACKGROUND

• 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.

  PMID: 30100001 BACKGROUND

• 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.

  PMID: 29428291 BACKGROUND

• Gardoki-Souto I, Redolar-Ripoll D, Fontana M, Hogg B, Castro MJ, Blanch JM, Ojeda F, Solanes A, Radua J, Valiente-Gomez A, Cirici R, Perez V, Amann BL, Moreno-Alcazar A. Prevalence and Characterization of Psychological Trauma in Patients with Fibromyalgia: A Cross-Sectional Study. Pain Res Manag. 2022 Nov 30;2022:2114451. doi: 10.1155/2022/2114451. eCollection 2022.

  PMID: 36504759 DERIVED

Related Links

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

MeSH Terms

Conditions

Fibromyalgia; Psychological Trauma; Pain; Anxiety Disorders; Depression; Parasomnias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Wake Disorders

Study Officials

• Ana Moreno-Alcázar, PhD.

  IMIM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 20, 2020
• Study Start: June 3, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

ES (1)