FibromyalgiaNCT04476316
Prevalence of the Traumatic Events in Women With Fibromyalgia
An observational study of Fibromyalgia and Psychological Trauma, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia, Psychological Trauma, Pain
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
Study population: The study sample will consist in 83 patients diagnosed with FM recruited by different services of the Parc de Salut Mar.
Who may be able to join
- Women with FM diagnosis.
- Age between 18-70.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Clinical Characterization of Traumatic Events in Women With Fibromyalgia
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.
Read the 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:
- 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.
- 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.
- 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
- Medical subject headings
- Fibromyalgia, Psychological Trauma, Pain, Anxiety Disorders, Depression, Parasomnias
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start3 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Moreno Alcázar, Parc de Salut Mar
- Investigators
- Ana Moreno-Alcázar, PhD., Principal investigator, IMIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476316
- Sponsor's protocol ID
- 2020/9158
- Status last verified
- Mar 2021
- First submitted
- 7 Jul 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27402412Cabo-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.
PubMed 28734619Collado 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.
PubMed 25385047Hauser 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.
PubMed 23685006Kok 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.
PubMed 25687377Morgan 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.
PubMed 30100001Yavne 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.
PubMed 29428291Gardoki-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.
PubMed 36504759
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Characterization of Traumatic Events in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04476316
- Acronym / sponsor ID
- 2020/9158
- Conditions
- Fibromyalgia, Psychological Trauma, Pain, Anxiety, Depression, Sleep Disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study sample will consist in 83 patients diagnosed with FM recruited by different services of the Parc de Salut Mar.
Key inclusion criteria (2 listed)
- Women with FM diagnosis.
- Age between 18-70.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Background: PubMed 27402412Burke 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.
- Background: PubMed 28734619Cabo-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.
- Background: PubMed 25385047Collado 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.
- Background: PubMed 23685006Hauser 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.
- Background: PubMed 25687377Kok 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.
- Background: PubMed 30100001Morgan 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.
- Background: PubMed 29428291Yavne 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.
- Derived from this study: PubMed 36504759Gardoki-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.
- Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates, Publishers.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Moreno-Alcázar, PhD. principal investigator
IMIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Psychological Trauma, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of pain assessed with the Visual Analogic Scale Questionnaire (VAS) (time frame: 1 week). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04476316, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.