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
|Condition or disease|
|Fibromyalgia Psychological Trauma Pain Anxiety Depression Sleep Disturbance Quality of Life|
|Study Type :||Observational|
|Estimated Enrollment :||83 participants|
|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|
- 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).
- 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).
- 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).
- 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.
- 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).
- 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.
- 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".
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Ana Moreno-Alcázar, PhD.||+34 933268500 ext email@example.com|
|Parc Salut Mar||Recruiting|
|Barcelona, Spain, 08019|
|Contact: Ana Moreno-Alcázar, PhD. +34 933268500 ext 8403 firstname.lastname@example.org|
|Principal Investigator:||Ana Moreno-Alcázar, PhD.||IMIM|