FibromyalgiaNCT05323838
Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia.
An observational study of Fibromyalgia and Chronic Fatigue Syndrome, run by University of Extremadura at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome, Comorbidities and Coexisting Conditions
- What is being tested?
- Subjective quality of live, Blood extraction and Accelerometry
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jun 2021to 16 Nov 2024
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The present investigation is carried out in two experimental groups: patients diagnosed with Fibromyalgia and patients diagnosed with Fibromyalgia and a co-diagnosis of Chronic Fatigue Syndrome, all of them volunteers facilitated through the Fibromyalgia Associations of Badajoz and Cáceres, Extremadura, Spain.
Who may be able to join
- Fibromyalgia and/or Chronic Fatigue Syndrome diagnosis by rheumatologists or internal medicine professionals.
- Age not less than 40 years old and not more than 65 years old.
Who cannot join
- Suffering from diagnosed "major depression".
- Suffer diagnosed multiple chemical sensitivity.
- Corticosteroid treatment or anti-cytokine therapies.
- Periodically carry out programmed therapeutic physical activity in the two months prior to the accelerometry tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia on Physical Activity, Quality of Life and Immunoneuroendocrine Response.
The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.
Read the detailed description
The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.
- Being tested
- Subjective quality of live, Blood extraction, Accelerometry, Synbiotic complement
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjective quality of liveBehavioural
The groups fill out scientifically validated questionnaires to know the differences in perceived stress, anxiety, quality of life, depression, quality of sleep, pain, fatigue, and impact of the disease on daily life.
Blood extractionProcedure or surgery
Blood collection by qualified personnel.
AccelerometryBehavioural
To know the objective differences between physical activity/sedentary lifestyle, caloric expenditure and quality of sleep, we used the accelerometry technique
Synbiotic complementDietary supplement
On two separate days, the "baseline-tests" and "final-tests" were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the "final-test" and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic).
| Study group | Role | What they receive |
|---|---|---|
| Control Healthy Women | Aged-matched control group of healthy women. Receives: Behavioral: Subjective quality of live; Procedure: Blood extraction; Behavioral: Accelerometry | |
| Only Fibromyalgia | Patients diagnosed only with fibromyalgia. Receives: Behavioral: Subjective quality of live; Procedure: Blood extraction; Behavioral: Accelerometry; Dietary Supplement: Synbiotic complement | |
| Fibromyalgia and Chronic Fatigue Syndrome | Patients diagnosed with fibromyalgia and chronic fatigue syndrome. Receives: Behavioral: Subjective quality of live; Procedure: Blood extraction; Behavioral: Accelerometry; Dietary Supplement: Synbiotic complement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory (STAI) is a self-reported, scientifically validated questionnaire that measures perceived anxiety. The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: During the intervention, at day 1.
Differences in perceived stress using The Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a self-reported, scientifically validated questionnaire that measures perceived stress. This scale is a self- report instrument that evaluates the level of perceived stress during the last month, and consists of 14 items with a 5-point response scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10, and 13 (in the following manner: 0 = 4, 1 = 3, 2 = 2, 3 = 1, and 4 = 0) and subsequently adding the 14 item scores. A higher score indicates a higher level of perceived stress.
Measured: During the intervention, at day 1.
Differences in perceived depression using the Beck's Depression Inventory (BDI)
Beck's Depression Inventory (BDI) is a self-reported, scientifically validated questionnaire that measures perceived depression. Each of the 21 items on the BDI measures the presence and severity of a symptom of depression by requiring a self-rating from 0 to 3. Mild (low) scores are less than 4; moderate (medium) is between 14 and 20, and severe 21 and above. Unless otherwise indicated, the use of "mild," "moderate," and "severe" levels of depression throughout the remainder of this chapter will refer to the aforementioned ranges.
Measured: During the intervention, at day 1.
Differences in perceived pain using the Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI) is a self-reported, scientifically validated questionnaire that measures perceived pain. The BPI starts with a screening question, asking about the presence of pain and a body chart is used to indicate painful regions as well as the worst region. These items aren´t evaluated. This is followed by the core BPI items: the rating scales for pain severity and interference. Numerical rating scales from 0 to 10 are used for all items. The anchors for pain severity scales are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whilst the interference anchors are 0 = 'no interference' and 10 = 'interferes completely'.
Measured: During the intervention, at day 1.
Differences in perceived pain using the Brief Fatigue Inventory (BFI)
The Brief Fatigue Inventory (BFI) has nine items, with the items measured on 0-10 numeric rating scales. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and"now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The interference items are measured on a 0 -10 scale, with 0 beings "does not interfere" and 10 being "completely interferes."
Measured: During the intervention, at day 1.
Differences in subjective quality of sleep using The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality lndex (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring.
The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21 " indicating severe difficulties in all areas.
Measured: During the intervention, at day 1.
Differences in subjective quality of life using The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ)
The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ) This is a 26-item tool in which the respondent is asked to indicate the frequency of adopting 26 positively stated lifestyle habits using a Likert-type scale (1=Never or rarely, 2=Sometimes, 3=Often, and 4 = Always).
Measured: During the intervention, at day 1.
Differences in perceived anxiety related to Coronavirus Disease (COVID-19) using the Coronavirus Anxiety Scale (CAS)
The Coronavirus Anxiety Scale is a brief mental health screener that can be used to identify cases of dysfunctional anxiety related to COVID-19. The items measure physiologically-based symptoms that are aroused with coronavirus-related information and thoughts using a 5-point time anchored scale (0=not at all to 4=nearly every day over the last 2 weeks).
Measured: During the intervention, at day 1.
Differences in fear of Coronavirus Disease (COVID-19) using the Fear COVID-19 Scale (FCV-19S)
The Fear of COVID-19 Scale (FCV-19S) is used to identify and intervene early, psychologically, in people with high values of fear of COVID-19. This one-dimensional scale is made up of seven items with a 5-point Likert response ranging from 1 (strongly disagree) to 5 (strongly agree) and the total tables can range between 7 and 35 points. The higher the score, the greater the fear of COVID-19 infection.
Measured: During the intervention, at day 1.
Objective differences in physical activity, sedentary lifestyle and sleep using the accelerometer technique (ActiGraph)
An accelerometer is a small device, like a wristwatch, used to measure physical activity level, patterns of activity, sedentary levels, sleep patterns, and the expenditure of calories consumed, basal and total Metabolic Equivalent of Task (METs) used as an assessment of the metabolism of the person wearing it.
Measured: Up to 1 week
Determination of immuno-neuroendocrine parameters (cytokines, catecholamines, and stress hormones)
Cytokines (IL-8, IL-10), catecholamines (such as epinephrine, and norepinephrine) as well as stress hormones (serotonin and cortisol), were analyzed by competitive inhibition enzyme immunoassays (ELISA)
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start9 Jun 2021
- Primary completion22 Jun 2021
- Study completion16 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Otero Calderón, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323838
- Sponsor's protocol ID
- TesisEDUFM
- Status last verified
- May 2023
- First submitted
- 18 Mar 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adler GK, Geenen R. Hypothalamic-pituitary-adrenal and autonomic nervous system functioning in fibromyalgia. Rheum Dis Clin North Am. 2005 Feb;31(1):187-202, xi. doi: 10.1016/j.rdc.2004.10.002.
PubMed 15639063Guillen-Riquelme A, Buela-Casal G. [Meta-analysis of group comparison and meta-analysis of reliability generalization of the State-Trait Anxiety Inventory Questionnaire (STAI)]. Rev Esp Salud Publica. 2014 Jan-Feb;88(1):101-12. doi: 10.4321/S1135-57272014000100007. Spanish.
PubMed 24728394Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.
PubMed 16673626BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.
PubMed 26303366Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.
PubMed 10091805Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Darviri C, Alexopoulos EC, Artemiadis AK, Tigani X, Kraniotou C, Darvyri P, Chrousos GP. The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ): a novel tool for assessing self-empowerment through a constellation of daily activities. BMC Public Health. 2014 Sep 24;14:995. doi: 10.1186/1471-2458-14-995.
PubMed 25253039Freedson P, Bowles HR, Troiano R, Haskell W. Assessment of physical activity using wearable monitors: recommendations for monitor calibration and use in the field. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S1-4. doi: 10.1249/MSS.0b013e3182399b7e.
PubMed 22157769Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.
PubMed 32299304Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
PubMed 32226353
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia on Physical Activity, Quality of Life and Immunoneuroendocrine Response.
- ClinicalTrials.gov ID
- NCT05323838
- Acronym / sponsor ID
- TesisEDUFM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 16 Nov 2024 (estimated)
- First posted
- 12 Apr 2022 (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.
The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.
Detailed description
The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Healthy Women | – | Behavioral: Subjective quality of live, Procedure: Blood extraction, Behavioral: AccelerometryAged-matched control group of healthy women. |
| Only Fibromyalgia | – | Behavioral: Subjective quality of live, Procedure: Blood extraction, Behavioral: Accelerometry, Dietary Supplement: Synbiotic complementPatients diagnosed only with fibromyalgia. |
| Fibromyalgia and Chronic Fatigue Syndrome | – | Behavioral: Subjective quality of live, Procedure: Blood extraction, Behavioral: Accelerometry, Dietary Supplement: Synbiotic complementPatients diagnosed with fibromyalgia and chronic fatigue syndrome. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The present investigation is carried out in two experimental groups: patients diagnosed with Fibromyalgia and patients diagnosed with Fibromyalgia and a co-diagnosis of Chronic Fatigue Syndrome, all of them volunteers facilitated through the Fibromyalgia Associations of Badajoz and Cáceres, Extremadura, Spain.
Key inclusion criteria (2 listed)
- Fibromyalgia and/or Chronic Fatigue Syndrome diagnosis by rheumatologists or internal medicine professionals.
- Age not less than 40 years old and not more than 65 years old.
Key exclusion criteria (4 listed)
- Suffering from diagnosed "major depression".
- Suffer diagnosed multiple chemical sensitivity.
- Corticosteroid treatment or anti-cytokine therapies.
- Periodically carry out programmed therapeutic physical activity in the two months prior to the accelerometry tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjective quality of liveThe groups fill out scientifically validated questionnaires to know the differences in perceived stress, anxiety, quality of life, depression, quality of sleep, pain, fatigue, and impact of the disease on daily life. | Behavioural | Control Healthy Women, Fibromyalgia and Chronic Fatigue Syndrome, Only Fibromyalgia |
| Blood extractionBlood collection by qualified personnel. | Procedure or surgery | Control Healthy Women, Fibromyalgia and Chronic Fatigue Syndrome, Only Fibromyalgia |
| AccelerometryTo know the objective differences between physical activity/sedentary lifestyle, caloric expenditure and quality of sleep, we used the accelerometry technique | Behavioural | Control Healthy Women, Fibromyalgia and Chronic Fatigue Syndrome, Only Fibromyalgia |
| Synbiotic complementOn two separate days, the "baseline-tests" and "final-tests" were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the "final-test" and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic). | Dietary supplement | Fibromyalgia and Chronic Fatigue Syndrome, Only Fibromyalgia |
Primary outcome
Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI)
Time frame: During the intervention, at day 1.
State-Trait Anxiety Inventory (STAI) is a self-reported, scientifically validated questionnaire that measures perceived anxiety. The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Differences in perceived stress using The Perceived Stress Scale (PSS)
Time frame: During the intervention, at day 1.
The Perceived Stress Scale (PSS) is a self-reported, scientifically validated questionnaire that measures perceived stress. This scale is a self- report instrument that evaluates the level of perceived stress during the last month, and consists of 14 items with a 5-point response scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10, and 13 (in the following manner: 0 = 4, 1 = 3, 2 = 2, 3 = 1, and 4 = 0) and subsequently adding the 14 item scores. A higher score indicates a higher level of perceived stress.
Differences in perceived depression using the Beck's Depression Inventory (BDI)
Time frame: During the intervention, at day 1.
Beck's Depression Inventory (BDI) is a self-reported, scientifically validated questionnaire that measures perceived depression. Each of the 21 items on the BDI measures the presence and severity of a symptom of depression by requiring a self-rating from 0 to 3. Mild (low) scores are less than 4; moderate (medium) is between 14 and 20, and severe 21 and above. Unless otherwise indicated, the use of "mild," "moderate," and "severe" levels of depression throughout the remainder of this chapter will refer to the aforementioned ranges.
Differences in perceived pain using the Brief Pain Inventory (BPI)
Time frame: During the intervention, at day 1.
Brief Pain Inventory (BPI) is a self-reported, scientifically validated questionnaire that measures perceived pain. The BPI starts with a screening question, asking about the presence of pain and a body chart is used to indicate painful regions as well as the worst region. These items aren´t evaluated. This is followed by the core BPI items: the rating scales for pain severity and interference. Numerical rating scales from 0 to 10 are used for all items. The anchors for pain severity scales are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whilst the interference anchors are 0 = 'no interference' and 10 = 'interferes completely'.
Differences in perceived pain using the Brief Fatigue Inventory (BFI)
Time frame: During the intervention, at day 1.
The Brief Fatigue Inventory (BFI) has nine items, with the items measured on 0-10 numeric rating scales. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and"now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The interference items are measured on a 0 -10 scale, with 0 beings "does not interfere" and 10 being "completely interferes."
Differences in subjective quality of sleep using The Pittsburgh Sleep Quality Index (PSQI)
Time frame: During the intervention, at day 1.
The Pittsburgh Sleep Quality lndex (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21 " indicating severe difficulties in all areas.
Differences in subjective quality of life using The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ)
Time frame: During the intervention, at day 1.
The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ) This is a 26-item tool in which the respondent is asked to indicate the frequency of adopting 26 positively stated lifestyle habits using a Likert-type scale (1=Never or rarely, 2=Sometimes, 3=Often, and 4 = Always).
Differences in perceived anxiety related to Coronavirus Disease (COVID-19) using the Coronavirus Anxiety Scale (CAS)
Time frame: During the intervention, at day 1.
The Coronavirus Anxiety Scale is a brief mental health screener that can be used to identify cases of dysfunctional anxiety related to COVID-19. The items measure physiologically-based symptoms that are aroused with coronavirus-related information and thoughts using a 5-point time anchored scale (0=not at all to 4=nearly every day over the last 2 weeks).
Differences in fear of Coronavirus Disease (COVID-19) using the Fear COVID-19 Scale (FCV-19S)
Time frame: During the intervention, at day 1.
The Fear of COVID-19 Scale (FCV-19S) is used to identify and intervene early, psychologically, in people with high values of fear of COVID-19. This one-dimensional scale is made up of seven items with a 5-point Likert response ranging from 1 (strongly disagree) to 5 (strongly agree) and the total tables can range between 7 and 35 points. The higher the score, the greater the fear of COVID-19 infection.
Objective differences in physical activity, sedentary lifestyle and sleep using the accelerometer technique (ActiGraph)
Time frame: Up to 1 week
An accelerometer is a small device, like a wristwatch, used to measure physical activity level, patterns of activity, sedentary levels, sleep patterns, and the expenditure of calories consumed, basal and total Metabolic Equivalent of Task (METs) used as an assessment of the metabolism of the person wearing it.
Determination of immuno-neuroendocrine parameters (cytokines, catecholamines, and stress hormones)
Time frame: Through study completion, an average of 2 year
Cytokines (IL-8, IL-10), catecholamines (such as epinephrine, and norepinephrine) as well as stress hormones (serotonin and cortisol), were analyzed by competitive inhibition enzyme immunoassays (ELISA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 15639063Adler GK, Geenen R. Hypothalamic-pituitary-adrenal and autonomic nervous system functioning in fibromyalgia. Rheum Dis Clin North Am. 2005 Feb;31(1):187-202, xi. doi: 10.1016/j.rdc.2004.10.002.
- Background: PubMed 24728394Guillen-Riquelme A, Buela-Casal G. [Meta-analysis of group comparison and meta-analysis of reliability generalization of the State-Trait Anxiety Inventory Questionnaire (STAI)]. Rev Esp Salud Publica. 2014 Jan-Feb;88(1):101-12. doi: 10.4321/S1135-57272014000100007. Spanish.
- Background: PubMed 16673626Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 26303366Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.
- Background: PubMed 10091805Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 25253039Darviri C, Alexopoulos EC, Artemiadis AK, Tigani X, Kraniotou C, Darvyri P, Chrousos GP. The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ): a novel tool for assessing self-empowerment through a constellation of daily activities. BMC Public Health. 2014 Sep 24;14:995. doi: 10.1186/1471-2458-14-995.
- Background: PubMed 22157769Freedson P, Bowles HR, Troiano R, Haskell W. Assessment of physical activity using wearable monitors: recommendations for monitor calibration and use in the field. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S1-4. doi: 10.1249/MSS.0b013e3182399b7e.
- Background: PubMed 32299304Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.
- Background: PubMed 32226353Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Fatigue Syndrome, run by University of Extremadura 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 4 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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?
Results are not available in the source record.
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?
Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI) (time frame: During the intervention, at day 1.). The study lists 11 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 NCT05323838, which also lists 11 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 11 May 2023.