Systemic SclerosisNCT04212247
Trial on Outpatients With Systemic Sclerosis Treated With Well-Being Therapy or With a Control Therapy
A study testing Well-Being Therapy in people with Systemic Sclerosis, run by University of Florence at 2 sites in Italy.
Trial summary
Systemic sclerosis (SSc) is a rare and potentially life-threatening autoimmune disorder with a significant impact on health and quality of life. The non-pharmacological interventions address to psychological sequalae currently available are limited and have poor efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Well-Being Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jun 2020to 31 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able and interested in participating to the research, as proved by signed Informed consent;
- a diagnosis of SSc (limited or diffuse) according to LeRoy et al. (1998);
- age higher than 18 years
Who cannot join
- co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders, 5th edition (American Psychiatric Association, 2013) as diagnosed via the Mini-International Neuropsychiatric Interview;
- currently under psychotherapy;
- change of the pharmacological treatment (including psychotropic medications) during the last three months.
- any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Rheumtoi Unit, Academic Hospital Careggi
Florence, 50135
Fiammetta Cosci
Florence
About this study
Official title: Randomized Controlled Trial for Testing the Efficacy of Well-Being Therapy in Patients With Systemic Sclerosis
Systemic sclerosis (SSc) is a rare and potentially life-threatening autoimmune disorder with a significant impact on health and quality of life. The non-pharmacological interventions address to psychological sequalae currently available are limited and have poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. WBT has never been tested in SSc and it might represent a useful complementary therapeutic option to improve SSc patients' well-being. The aim of the present study is to evaluate the psychological status of the SSc patients and to test the efficacy of WBT in a sample of SSc patients if compared to a control condition.
Read the detailed description
Systemic sclerosis (SSc) is a rare, multisystem, chronic autoimmune connective tissue disease characterized by fibrosis of the skin and internal organs, skin thickening, and decreased organ functioning leading to dermatologic, vascular, pulmonary, cardiac, gastrointestinal, neurological, musculoskeletal, and renal complications. SSc patients often suffer from psychological impairments, such as depression, anxiety about disease progression, body image dissatisfaction and low self-esteem. The non-pharmacological interventions for the treatment of the psychological sequelae of systemic sclerosis currently available are limited and have shown poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has been manualized in 2016 and has shown efficacy in randomized clinical trials. It showed to be effective in decreasing the relapse rates of depression in adults, it showed to be effective in generalized anxiety disorder and in cyclothymia. No psychological treatment aimed at empowering the level of psychological well-being rather than at working on distress in SSc patients have been implemented although it was shown that such kind of interventions directly increase the level of psychological well-being and indirectly decrease the level of psychological distress (i.e., anxious and depressive symptoms) in subjects affected by chronic diseases. The aim of the present study is to evaluate the psychological status of SSc patients with specific attention to suffering and mental pain, and to test the efficacy of WBT in SSc subjects if compared to a control condition. Thus, sixty outpatients with a diagnosis of SSc will be enrolled and will receive WBT or the control condition.
- Conditions
- Systemic Sclerosis
- Being tested
- Well-Being Therapy, Control condition
- Keywords
- systemic sclerosis, well-being, psychological distress, suffering, mental pain, well-being therapy, psychotherapy
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being TherapyBehavioural
Well-Being Therapy (WBT) is a short-term psychotherapeutic strategy, that emphasizes self-observation with the use of a structured diary, interaction between patients and therapists and homework. WBT was based on the model of psychological well-being that was originally developed by Jahoda in 1958 and further refined by Ryff in 2014. The standard number of sessions is 8. The initial phase is concerned with self-observation of psychological well-being. Then, the patient is encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of wellbeing. The final part involves cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail.
Control conditionBehavioural
The control condition will include 8 sessions that will inform participants about well-being and lifestyles which can influence it. They will be articulated as follows. Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drug misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed.
| Study group | Role | What they receive |
|---|---|---|
| Well-being therapy | Experimental | WBT will be used as the only non-pharmacological therapeutic strategy and 8 sessions will be delivered every other week with a duration of 60 minutes each. The manualized WBT will be used (Fava, 2016). Thus, the initial phase will be concerned with self-observation of psychological well-being. Once the instances of well-being will be properly recognized, the patient will be encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of well-being (intermediate phase). The final part will involve cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail. Receives: Behavioral: Well-Being Therapy |
| Control condition | Placebo comparator | The control condition will include 8 every other week sessions based on Lifestyle and well-being National Institute for health and Care Excellence (NICE) guidelines (https://www.nice.org.uk/guidance/lifestyle-andwellbeing) and on World Health Organization 12 steps to healthy eating (http://www.euro.who.int/en/ health-topics/disease-prevention/nutrition/a-healthylifestyle). These sessions will inform participants about well-being and lifestyles which can influence it. Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability due to systemic sclerosis
The primary outcome will be the level of disability due to systemic sclerosis, assessed via the Health Assessment Questionnaire Disability Index (minimum: 0, maximum: 40, the highest the score the highest the level of disability).
Measured: change from baseline to 6-month follow up
Secondary outcomes (11)
Psychiatric status
Psychiatric status assessed via the Mini-International Neuropsychiatric Interview (no score applicable)
Measured: change from baseline to 6-month follow up
Psychosomatic status
Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (no score applicable)
Measured: change from baseline to 6-month follow up
Well-being
World Health Organization-Five Well-Being Index (min: 0, max: 25, the highest score corresponds to the lowest level of well-being)
Measured: change from baseline to 6-month follow up
Psychological well-being
the Psychological Well-Being Questionnaire (min: 0, max: 504, the highest score corresponds to the highest level of psychological well-being)
Measured: change from baseline to 6-month follow up
Euthymia
Euthymia Scale (min: 0, max: 60, the highest score corresponds to highest level of euthymia)
Measured: change from baseline to 6-month follow up
Suffering
Pictorial Representation of Illness and Self-Measure (min: 0, max: 30, the highest score corresponds to the lowest level of suffering)
Measured: change from baseline to 6-month follow up
Psychological distress
Symptom Questionnaire (min: 0, max: 92, the highest score corresponds to the highest level of psychological distress)
Measured: change from baseline to 6-month follow up
Pain in the body
Brief Pain Inventory (min: 0, max: 70, the highest score corresponds to highest level of pain)
Measured: change from baseline to 6-month follow up
Mental pain
Mental Pain Questionnaire (min: 0, max: 20, the highest score corresponds to the highest level of mental pain)
Measured: change from baseline to 6-month follow up
Psychiatric symptoms
Symptom Checklist-90-Revised (min: 0, max: 320, the highest score corresponds to the highest level of symptoms severity)
Measured: change from baseline to 6-month follow up
Harmony
Visual analouge scale (min: 0, max: 100, the highest score corresponds to the highest level of harmony)
Measured: change from baseline to 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Jun 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot study, designed as a randomized (1:1) controlled trial, comparing WBT vs a control condition. The patients will receive a baseline assessment to confirm the diagnosis of systemic sclerosis, then socio-demographic information, information on pharmacological/non-pharmacological treatments, on the history of medical diseases and on the psychological status will be collected. Thereafter, the subjects will be randomly assigned to WBT or to a control condition. The subjects will be re-assessed at the end of session 4, 8 of treatment, and at 6-month follow-up.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiammetta Cosci, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212247
- Sponsor's protocol ID
- WBT in SSc
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romanazzo S, Ceccatelli S, Mansueto G, Sera F, Guiducci S, Matucci Cerinic M, Cosci F. Well-Being Therapy in systemic sclerosis outpatients: a randomized controlled trial. Rheumatology (Oxford). 2025 Feb 1;64(2):667-674. doi: 10.1093/rheumatology/keae114.
PubMed 38366929
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Testing the Efficacy of Well-Being Therapy in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04212247
- Acronym / sponsor ID
- WBT in SSc
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, well-being, psychological distress, suffering, mental pain, well-being therapy, psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 26 Dec 2019 (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.
Systemic sclerosis (SSc) is a rare and potentially life-threatening autoimmune disorder with a significant impact on health and quality of life. The non-pharmacological interventions address to psychological sequalae currently available are limited and have poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. WBT has never been tested in SSc and it might represent a useful complementary therapeutic option to improve SSc patients' well-being. The aim of the present study is to evaluate the psychological status of the SSc patients and to test the efficacy of WBT in a sample of SSc patients if compared to a control condition.
Detailed description
Systemic sclerosis (SSc) is a rare, multisystem, chronic autoimmune connective tissue disease characterized by fibrosis of the skin and internal organs, skin thickening, and decreased organ functioning leading to dermatologic, vascular, pulmonary, cardiac, gastrointestinal, neurological, musculoskeletal, and renal complications. SSc patients often suffer from psychological impairments, such as depression, anxiety about disease progression, body image dissatisfaction and low self-esteem. The non-pharmacological interventions for the treatment of the psychological sequelae of systemic sclerosis currently available are limited and have shown poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has been manualized in 2016 and has shown efficacy in randomized clinical trials. It showed to be effective in decreasing the relapse rates of depression in adults, it showed to be effective in generalized anxiety disorder and in cyclothymia. No psychological treatment aimed at empowering the level of psychological well-being rather than at working on distress in SSc patients have been implemented although it was shown that such kind of interventions directly increase the level of psychological well-being and indirectly decrease the level of psychological distress (i.e., anxious and depressive symptoms) in subjects affected by chronic diseases. The aim of the present study is to evaluate the psychological status of SSc patients with specific attention to suffering and mental pain, and to test the efficacy of WBT in SSc subjects if compared to a control condition. Thus, sixty outpatients with a diagnosis of SSc will be enrolled and will receive WBT or the control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a pilot study, designed as a randomized (1:1) controlled trial, comparing WBT vs a control condition. The patients will receive a baseline assessment to confirm the diagnosis of systemic sclerosis, then socio-demographic information, information on pharmacological/non-pharmacological treatments, on the history of medical diseases and on the psychological status will be collected. Thereafter, the subjects will be randomly assigned to WBT or to a control condition. The subjects will be re-assessed at the end of session 4, 8 of treatment, and at 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Well-being therapy | Experimental | Behavioral: Well-Being TherapyWBT will be used as the only non-pharmacological therapeutic strategy and 8 sessions will be delivered every other week with a duration of 60 minutes each. The manualized WBT will be used (Fava, 2016). Thus, the initial phase will be concerned with self-observation of psychological well-being. Once the instances of well-being will be properly recognized, the patient will be encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of well-being (intermediate phase). The final part will involve cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail. |
| Control condition | Placebo comparator | Behavioral: Control conditionThe control condition will include 8 every other week sessions based on Lifestyle and well-being National Institute for health and Care Excellence (NICE) guidelines (https://www.nice.org.uk/guidance/lifestyle-andwellbeing) and on World Health Organization 12 steps to healthy eating (http://www.euro.who.int/en/ health-topics/disease-prevention/nutrition/a-healthylifestyle). These sessions will inform participants about well-being and lifestyles which can influence it. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able and interested in participating to the research, as proved by signed Informed consent;
- a diagnosis of SSc (limited or diffuse) according to LeRoy et al. (1998);
- age higher than 18 years
Key exclusion criteria (4 listed)
- co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders, 5th edition (American Psychiatric Association, 2013) as diagnosed via the Mini-International Neuropsychiatric Interview;
- currently under psychotherapy;
- change of the pharmacological treatment (including psychotropic medications) during the last three months.
- any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
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 |
|---|---|---|
| Well-Being TherapyWell-Being Therapy (WBT) is a short-term psychotherapeutic strategy, that emphasizes self-observation with the use of a structured diary, interaction between patients and therapists and homework. WBT was based on the model of psychological well-being that was originally developed by Jahoda in 1958 and further refined by Ryff in 2014. The standard number of sessions is 8. The initial phase is concerned with self-observation of psychological well-being. Then, the patient is encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of wellbeing. The final part involves cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail. | Behavioural | Well-being therapy |
| Control conditionThe control condition will include 8 sessions that will inform participants about well-being and lifestyles which can influence it. They will be articulated as follows. Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drug misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed. | Behavioural | Control condition |
Primary outcome
Disability due to systemic sclerosis
Time frame: change from baseline to 6-month follow up
The primary outcome will be the level of disability due to systemic sclerosis, assessed via the Health Assessment Questionnaire Disability Index (minimum: 0, maximum: 40, the highest the score the highest the level of disability).
11 secondary outcomes
Psychiatric status
Time frame: change from baseline to 6-month follow up
Psychosomatic status
Time frame: change from baseline to 6-month follow up
Well-being
Time frame: change from baseline to 6-month follow up
Psychological well-being
Time frame: change from baseline to 6-month follow up
Euthymia
Time frame: change from baseline to 6-month follow up
Suffering
Time frame: change from baseline to 6-month follow up
Psychological distress
Time frame: change from baseline to 6-month follow up
Pain in the body
Time frame: change from baseline to 6-month follow up
Mental pain
Time frame: change from baseline to 6-month follow up
Psychiatric symptoms
Time frame: change from baseline to 6-month follow up
Harmony
Time frame: change from baseline to 6-month follow up
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 29 Nov 2023.
- Derived from this study: PubMed 38366929Romanazzo S, Ceccatelli S, Mansueto G, Sera F, Guiducci S, Matucci Cerinic M, Cosci F. Well-Being Therapy in systemic sclerosis outpatients: a randomized controlled trial. Rheumatology (Oxford). 2025 Feb 1;64(2):667-674. doi: 10.1093/rheumatology/keae114.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-Being Therapy in people with Systemic Sclerosis, run by University of Florence at 2 sites in Italy.
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 3 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. Some participants in this study may receive a placebo. 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?
Disability due to systemic sclerosis (time frame: change from baseline to 6-month follow up). 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 NCT04212247, which also lists 1 linked publication.
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 29 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.