SclerodermaNCT05617066
Stress, Scleroderma and Quality of Life
A study testing Cognitive behavioral therapy in people with Scleroderma, run by Asociación Española de Esclerodermia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 26 Nov 2022to 1 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis made by a specialist doctor, good command of the Spanish language (oral and written comprehension) and have an internet connection.
Who cannot join
- No psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Stress and Systemic Sclerosis
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:
Read more
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.
Read the 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 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.
- Conditions
- Scleroderma
- Being tested
- Cognitive behavioral therapy
- Keywords
- scleroderma, stress, cognitive behavioral therapy
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
With the cognitive behavioral therapy will work on different aspects for coping and tools psychological stress.
| Study group | Role | What they receive |
|---|---|---|
| therapy vs psychological support and usual care | Active comparator | Comparison between therapy groups vs psychological support and usual care. Only one group receive therapy. Receives: Behavioral: Cognitive behavioral therapy |
| therapy and psychological support versus control group | No intervention | Comparison between therapy groups vs psychological support and usual care. Only one group receive therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol y psychological stress levels
Decreased cortisol and psychological stress after therapy
Measured: 3 months
Secondary outcomes (1)
Quality of life and psychological status
Improvement of quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start26 Nov 2022
- Primary completion31 Mar 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Española de Esclerodermia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Montero Lopez, Asociación Española de Esclerodermia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617066
- Sponsor's protocol ID
- AEE
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Stress and Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05617066
- Acronym / sponsor ID
- AEE
- Conditions
- Scleroderma
- Keywords
- scleroderma, stress, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Asociación Española de EsclerodermiaUniversity, hospital or other
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 15 Nov 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.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapy vs psychological support and usual care | Active comparator | Behavioral: Cognitive behavioral therapyComparison between therapy groups vs psychological support and usual care. Only one group receive therapy. |
| therapy and psychological support versus control group | No intervention | –Comparison between therapy groups vs psychological support and usual care. Only one group receive therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis made by a specialist doctor, good command of the Spanish language (oral and written comprehension) and have an internet connection.
Key exclusion criteria (1 listed)
- No psychiatric illness.
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 |
|---|---|---|
| Cognitive behavioral therapyWith the cognitive behavioral therapy will work on different aspects for coping and tools psychological stress. | Behavioural | therapy vs psychological support and usual care |
Primary outcome
Cortisol y psychological stress levels
Time frame: 3 months
Decreased cortisol and psychological stress after therapy
1 secondary outcome
Quality of life and psychological status
Time frame: 3 months
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 1 Feb 2024.
- 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?
A study testing Cognitive behavioral therapy in people with Scleroderma, run by Asociación Española de Esclerodermia 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 1 inclusion and 1 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 1 Feb 2024. 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?
Cortisol y psychological stress levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.