Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05617066 |
| Other study ID # |
AEE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 26, 2022 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Asociación Española de Esclerodermia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 1.5 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 1.5 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.
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 Raynaud's, 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 and/or alcohol
use.
For the psychological evaluation, the following instruments will be completed:Perceived
Stress Scale (EEP-14). It's 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 internal=.81 and test-retest= 0.73). Stress
Vulnerability Inventory (IVE). This questionnaire assesses the individual's 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 Cronbach's alpha reliability
coefficient is 0.87.
Connor and Davidson Resilience. Assesses resilience being understood as the individual's
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 0.89. 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 Cronbach's alpha for internal consistency of
0.81.
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,
pain/discomfort, and anxiety/depression) 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 scale.It 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-36.Short 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.
