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Prevalence of the Traumatic Events in Women With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04476316
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ana Moreno Alcázar, 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.

Condition or disease
Fibromyalgia Psychological Trauma Pain Anxiety Depression Sleep Disturbance Quality of Life

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Study Type : Observational
Estimated Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence and Clinical Characterization of Traumatic Events in Women With Fibromyalgia
Actual Study Start Date : June 3, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia




Primary Outcome Measures :
  1. Levels of pain assessed with the Visual Analogic Scale Questionnaire (VAS) [ Time Frame: 1 week ]
    Severity in pain intensity will be assessed with the Visual Analogic Scale (rated in a continuum from 0 to 10).

  2. Levels of pain assessed with the Pain Dissability Index (PDI) [ Time Frame: 1 week ]
    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).

  3. Levels of pain assessed with the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 1 week ]
    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).

  4. Presence of Postraumatic Stress Disorder (PTSD) evaluated with the Evaluación Global de Estrés Postraumático (EGEP-5) [ Time Frame: 1 week ]
    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.

  5. Levels of trauma associated symptoms assessed with the Impact of Events Scale-Revised (IES-R) [ Time Frame: 1 week ]
    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).

  6. Presence of stressful life events in the last year using Holmes & Rahe Social Readjustment Scale [ Time Frame: 1 week ]
    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.

  7. Presence of childhood trauma assessed by Childhood Trauma Quiestionnaire (CTQ) [ Time Frame: 1 week ]
    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".

  8. Levels of dissociation evaluated by Dissociative Experiences Scale (DES) [ Time Frame: 1 week ]
    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.

  9. Levels of somatoform dissociation assessed by Somatoform Dissociation Questionnaire 20 (SDQ-20) [ Time Frame: 1 week ]
    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.

  10. Levels of depressive symptoms assessed by with the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 week ]
    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.

  11. Levels of anxious symptoms evaluated with the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 week ]
    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.

  12. Presence of psyquiatric comorbid disorders assessed by MINI International Neuropsychiatric Interview [ Time Frame: 1 week ]
    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.

  13. Levels of sleep disturbances using Athens Insomnia Scale (AIS) [ Time Frame: 1 week ]
    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.

  14. Levels of life satisfaction measured with Satisfaction With Life Questionnaire (SWLS) [ Time Frame: 1 week ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476316


Contacts
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Contact: Ana Moreno-Alcázar, PhD. +34 933268500 ext 8403 amoreno1@imim.es

Locations
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Spain
Parc Salut Mar Recruiting
Barcelona, Spain, 08019
Contact: Ana Moreno-Alcázar, PhD.    +34 933268500 ext 8403    amoreno1@imim.es   
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Ana Moreno-Alcázar, PhD. IMIM
Additional Information:
Publications:

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Responsible Party: Ana Moreno Alcázar, Principal Investigator, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04476316    
Other Study ID Numbers: 2020/9158
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Dyssomnias
Parasomnias
Psychological Trauma
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sleep Wake Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders