Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05617066
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2022-11-09
Brief Title:
Stress Scleroderma and Quality of Life
Sponsor:
Asociación Española de Esclerodermia
Organization:
Asociación Española de Esclerodermia
Study Overview
Official Title:
Psychological Stress and Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
150 patients of legal age will participate in this project diagnosed with systemic sclerosis
Patients will be randomly assigned as will be detailed later to one of the following three groups
Therapy Group GT This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress online modality in groups of 10-12 people during twelve sessions Consecutive weekly courses of 15 to 2 hours duration taught by psychology professionals of this mode 4 subgroups will be made Psychological Support Group AP This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma It will have a duration of twelve weekly sessions
Consecutive sessions of 15 to 2 hours in length taught by professional psychologists In this way they will 4 subgroups Usual Care Group CG This group will be made up of 50 patients who will follow their usual care Later once the study is over they will be offered to participate in coping with stress to the person who is interested
Patients will be randomly assigned as will be detailed later to one of the following three groups
Therapy Group GT This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress online modality in groups of 10-12 people during twelve sessions Consecutive weekly courses of 15 to 2 hours duration taught by psychology professionals of this mode 4 subgroups will be made Psychological Support Group AP This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma It will have a duration of twelve weekly sessions
Consecutive sessions of 15 to 2 hours in length taught by professional psychologists In this way they will 4 subgroups Usual Care Group CG This group will be made up of 50 patients who will follow their usual care Later once the study is over they will be offered to participate in coping with stress to the person who is interested
Detailed Description:
150 elderly patients diagnosed with systemic sclerosis in any of its variants both diffuse limited or sine scleroderma
The inclusion criteria are diagnosis made by a medical specialist good command of the Spanish language oral and written comprehension and have an internet connection As exclusion criteria they must not suffer no psychiatric illness Patients will be randomly assigned into each of the three groups
Informed consent Patients must be informed in writing of the objectives of the project and of the work protocol in which they are going to be included Once read and understood They will sign the consent The research staff is obliged to save said consents
Confidentiality and data protection commitment Ethical principles will be followed and deontological related to psychological research collected in the main codes currently nationally or internationally The Code of the Official College of Psychologists 1987 the Meta- Code of the European Federation of Psychological Associations 1995 and The Ethical Principles and Code of Conduct of Psychologists of the American Psychological Association 2002
Instruments
All the evaluation as well as the therapies will be carried out online through Google Form and GoogleMeet where questions regarding sociodemographic variables and information will be asked related to variables about your disease disease variant ESd ESl or ESss profile of autoantibodies age at diagnosis evolution time presence of Raynauds current digital ulcers pulmonary hypertension interstitial lung disease esophageal involvement intestinal involvement renal or cardiac involvement as well as current treatment Information will also be collected on possible comorbidities high blood pressure diabetes hypercholesterolemia or hypertriglyceridemia and toxic habits such as tobacco andor alcohol use
For the psychological evaluation the following instruments will be completedPerceived Stress Scale EEP-14 Its about a instrument that evaluates the perception of stress in different life situations It is composed of fourteen items on a five-point Likert-type scale It has adequate reliability consistency internal81 and test-retest 073 Stress Vulnerability Inventory IVE This questionnaire assesses the individuals predisposition to be influenced by perceived stress This composed of twenty-two dichotomous items and the maximum value that can be obtained is twenty-two points The Cronbachs alpha reliability coefficient is 087
Connor and Davidson Resilience Assesses resilience being understood as the individuals ability to coping and adapting to circumstances is made up of twenty-five Likert-type scale items of five points higher scores reflect greater resilience It has good reliability with an alpha of Cronbach of 089 Revised Symptom Inventory SCL-90-R It is an instrument with ninety items on a five-point Likert-type scale zero being nothing and four much which evaluates nine dimensions somatization obsession-compulsion depression anxiety hostility phobic anxiety paranoid ideation and psychoticism The scale also consists of seven extra items distributed into three global distress indices the GSI which measures global psychological distress the PSDI which is used to measure the intensity of symptoms and the Total Symptom Index which is used to measure the number of symptoms that the person reports The scores are transformed into percentiles 0-100 in this line the percentiles 75 represent clinical symptoms in any of the subscales of this instrument The nine dimensions show acceptable reliability with Cronbachs alpha for internal consistency of 081
EUROQOL-5Q health questionnaire Measure quality of life related to health HRQoL both in the general population and in groups of patients with different pathologies The individual himself assesses his state of health first in levels of severity by dimensions and then on a more general assessment visual analog scale A third element is the index of values that is obtained for each state of health generated by the instrument The descriptive system contains five dimensions of health mobility self-care activities of daily living paindiscomfort and anxietydepression and each of them has three levels of severity no problems some problems or moderate problems and serious problems In this part of the questionnaire the individual must mark the level gravity corresponding to his state of health in each of the dimensions referring to the same day to complete the questionnaire In each dimension severity levels are coded 1 if the response option is no I have problems with a 2 if the answer option is some or moderate problems and with a 3 if the answer option is many problems
DIENER life satisfaction scaleIt consists of five items that assess satisfaction with life through the global judgment that people make about this from the degree of agreement from 1 STRONGLY DISAGREE to 5 STRONGLY AGREE on five aspects if the type of life is similar to what has always been dreamed of having if the conditions of life are excellent if I am satisfied with my life if important things have been obtained and finally if I could live again I would like everything to be the same
Short Survey on Health SF-36Short survey on health of 36 items SF-36 of The 36 items measure eight dimensions Physical function limitations in physical activities due to health problems Social function limitations in social activities due to physical or emotional problems Physical role limitations in activities of roles due to physical health problems Body pain General mental health discomfort and well-being Social Role limitations in usual role activities due to problems emotional Vitality energy and fatigue Perception of general health
Evaluation of cortisol concentrations in hair Strands of hair with a diameter of Approximately 3 mm near the scalp in the middle posterior region of the head where the has indicated less variability in cortisol levels They will be cut with scissors clean as close to the scalp as possible not including the hair follicle itself not recommended for analysis Each hair sample will be kept in aluminum foil and inside an airtight bag so that neither light nor moisture penetrates the sample For this each participant will be sent both a tutorial as an envelope with the entire kit for collecting and storing the sample except the scissors for once collected they are sent to the laboratory of the Faculty of Pharmacy of the University of Granada where the levels of cortisol in hair will be analyzed and obtained This whole process will be totally free for the patients
The inclusion criteria are diagnosis made by a medical specialist good command of the Spanish language oral and written comprehension and have an internet connection As exclusion criteria they must not suffer no psychiatric illness Patients will be randomly assigned into each of the three groups
Informed consent Patients must be informed in writing of the objectives of the project and of the work protocol in which they are going to be included Once read and understood They will sign the consent The research staff is obliged to save said consents
Confidentiality and data protection commitment Ethical principles will be followed and deontological related to psychological research collected in the main codes currently nationally or internationally The Code of the Official College of Psychologists 1987 the Meta- Code of the European Federation of Psychological Associations 1995 and The Ethical Principles and Code of Conduct of Psychologists of the American Psychological Association 2002
Instruments
All the evaluation as well as the therapies will be carried out online through Google Form and GoogleMeet where questions regarding sociodemographic variables and information will be asked related to variables about your disease disease variant ESd ESl or ESss profile of autoantibodies age at diagnosis evolution time presence of Raynauds current digital ulcers pulmonary hypertension interstitial lung disease esophageal involvement intestinal involvement renal or cardiac involvement as well as current treatment Information will also be collected on possible comorbidities high blood pressure diabetes hypercholesterolemia or hypertriglyceridemia and toxic habits such as tobacco andor alcohol use
For the psychological evaluation the following instruments will be completedPerceived Stress Scale EEP-14 Its about a instrument that evaluates the perception of stress in different life situations It is composed of fourteen items on a five-point Likert-type scale It has adequate reliability consistency internal81 and test-retest 073 Stress Vulnerability Inventory IVE This questionnaire assesses the individuals predisposition to be influenced by perceived stress This composed of twenty-two dichotomous items and the maximum value that can be obtained is twenty-two points The Cronbachs alpha reliability coefficient is 087
Connor and Davidson Resilience Assesses resilience being understood as the individuals ability to coping and adapting to circumstances is made up of twenty-five Likert-type scale items of five points higher scores reflect greater resilience It has good reliability with an alpha of Cronbach of 089 Revised Symptom Inventory SCL-90-R It is an instrument with ninety items on a five-point Likert-type scale zero being nothing and four much which evaluates nine dimensions somatization obsession-compulsion depression anxiety hostility phobic anxiety paranoid ideation and psychoticism The scale also consists of seven extra items distributed into three global distress indices the GSI which measures global psychological distress the PSDI which is used to measure the intensity of symptoms and the Total Symptom Index which is used to measure the number of symptoms that the person reports The scores are transformed into percentiles 0-100 in this line the percentiles 75 represent clinical symptoms in any of the subscales of this instrument The nine dimensions show acceptable reliability with Cronbachs alpha for internal consistency of 081
EUROQOL-5Q health questionnaire Measure quality of life related to health HRQoL both in the general population and in groups of patients with different pathologies The individual himself assesses his state of health first in levels of severity by dimensions and then on a more general assessment visual analog scale A third element is the index of values that is obtained for each state of health generated by the instrument The descriptive system contains five dimensions of health mobility self-care activities of daily living paindiscomfort and anxietydepression and each of them has three levels of severity no problems some problems or moderate problems and serious problems In this part of the questionnaire the individual must mark the level gravity corresponding to his state of health in each of the dimensions referring to the same day to complete the questionnaire In each dimension severity levels are coded 1 if the response option is no I have problems with a 2 if the answer option is some or moderate problems and with a 3 if the answer option is many problems
DIENER life satisfaction scaleIt consists of five items that assess satisfaction with life through the global judgment that people make about this from the degree of agreement from 1 STRONGLY DISAGREE to 5 STRONGLY AGREE on five aspects if the type of life is similar to what has always been dreamed of having if the conditions of life are excellent if I am satisfied with my life if important things have been obtained and finally if I could live again I would like everything to be the same
Short Survey on Health SF-36Short survey on health of 36 items SF-36 of The 36 items measure eight dimensions Physical function limitations in physical activities due to health problems Social function limitations in social activities due to physical or emotional problems Physical role limitations in activities of roles due to physical health problems Body pain General mental health discomfort and well-being Social Role limitations in usual role activities due to problems emotional Vitality energy and fatigue Perception of general health
Evaluation of cortisol concentrations in hair Strands of hair with a diameter of Approximately 3 mm near the scalp in the middle posterior region of the head where the has indicated less variability in cortisol levels They will be cut with scissors clean as close to the scalp as possible not including the hair follicle itself not recommended for analysis Each hair sample will be kept in aluminum foil and inside an airtight bag so that neither light nor moisture penetrates the sample For this each participant will be sent both a tutorial as an envelope with the entire kit for collecting and storing the sample except the scissors for once collected they are sent to the laboratory of the Faculty of Pharmacy of the University of Granada where the levels of cortisol in hair will be analyzed and obtained This whole process will be totally free for the patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None