Trial on Outpatients With Systemic Sclerosis Treated With Well-Being Therapy or With a Control Therapy

Last updated: November 28, 2023
Sponsor: University of Florence
Overall Status: Completed

Phase

N/A

Condition

Collagen Vascular Diseases

Scleroderma

Connective Tissue Diseases

Treatment

Well-Being Therapy

Control condition

Clinical Study ID

NCT04212247
WBT in SSc
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. co-occurrence of psychiatric disorder(s) according to the Diagnostic and StatisticalManual of mental disorders, 5th edition (American Psychiatric Association, 2013) asdiagnosed via the Mini-International Neuropsychiatric Interview;
  2. currently under psychotherapy;
  3. change of the pharmacological treatment (including psychotropic medications) duringthe last three months.
  4. any other condition that, according to the Investigators' opinion, may alter theability of the patient to follow study procedures.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Well-Being Therapy
Phase:
Study Start date:
June 01, 2020
Estimated Completion Date:
October 31, 2023

Study 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.

Connect with a study center

  • Fiammetta Cosci

    Florence,
    Italy

    Site Not Available

  • Rheumtoi Unit, Academic Hospital Careggi

    Florence, 50135
    Italy

    Site Not Available

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