Clinical trial NCT04212247: Trial on Outpatients With Systemic Sclerosis Treated With Well-Being Therapy or With a Control Therapy
Official title: Randomized Controlled Trial for Testing the Efficacy of Well-Being Therapy in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis, well-being, psychological distress, suffering, mental pain, well-being therapy, psychotherapy
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. able and interested in participating to the research, as proved by signed Informed consent;
2. a diagnosis of SSc (limited or diffuse) according to LeRoy et al. (1998);
3. age higher than 18 years

Exclusion Criteria:

1. 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;
2. currently under psychotherapy;
3. change of the pharmacological treatment (including psychotropic medications) during the last three months.
4. any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.

Primary outcomes:
measure: Disability due to systemic sclerosis
timeFrame: change from baseline to 6-month follow up
Secondary outcomes:
measure: Psychiatric status
timeFrame: change from baseline to 6-month follow up
measure: Psychosomatic status
timeFrame: change from baseline to 6-month follow up
measure: Well-being
timeFrame: change from baseline to 6-month follow up
measure: Psychological well-being
timeFrame: change from baseline to 6-month follow up
measure: Euthymia
timeFrame: change from baseline to 6-month follow up
measure: Suffering
timeFrame: change from baseline to 6-month follow up
measure: Psychological distress
timeFrame: change from baseline to 6-month follow up
measure: Pain in the body
timeFrame: change from baseline to 6-month follow up
measure: Mental pain
timeFrame: change from baseline to 6-month follow up
measure: Psychiatric symptoms
timeFrame: change from baseline to 6-month follow up
measure: Harmony
timeFrame: change from baseline to 6-month follow up
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Rheumtoi Unit, Academic Hospital Careggi
city: Florence
country: Italy
facility: Fiammetta Cosci
Study officials:
References: