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

Systemic Sclerosis Clinical Trial

Official title:

Randomized Controlled Trial for Testing the Efficacy of Well-Being Therapy in Patients With Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212247
• Other study ID #: WBT in SSc
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Behavioral:
• Well-Being Therapy
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 condition
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.

Locations

Country	Name	City	State
Italy	Fiammetta Cosci	Florence
Italy	Rheumtoi Unit, Academic Hospital Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	change from baseline to 6-month follow up
Secondary	Psychiatric status	Psychiatric status assessed via the Mini-International Neuropsychiatric Interview (no score applicable)	change from baseline to 6-month follow up
Secondary	Psychosomatic status	Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (no score applicable)	change from baseline to 6-month follow up
Secondary	Well-being	World Health Organization-Five Well-Being Index (min: 0, max: 25, the highest score corresponds to the lowest level of well-being)	change from baseline to 6-month follow up
Secondary	Psychological well-being	the Psychological Well-Being Questionnaire (min: 0, max: 504, the highest score corresponds to the highest level of psychological well-being)	change from baseline to 6-month follow up
Secondary	Euthymia	Euthymia Scale (min: 0, max: 60, the highest score corresponds to highest level of euthymia)	change from baseline to 6-month follow up
Secondary	Suffering	Pictorial Representation of Illness and Self-Measure (min: 0, max: 30, the highest score corresponds to the lowest level of suffering)	change from baseline to 6-month follow up
Secondary	Psychological distress	Symptom Questionnaire (min: 0, max: 92, the highest score corresponds to the highest level of psychological distress)	change from baseline to 6-month follow up
Secondary	Pain in the body	Brief Pain Inventory (min: 0, max: 70, the highest score corresponds to highest level of pain)	change from baseline to 6-month follow up
Secondary	Mental pain	Mental Pain Questionnaire (min: 0, max: 20, the highest score corresponds to the highest level of mental pain)	change from baseline to 6-month follow up
Secondary	Psychiatric symptoms	Symptom Checklist-90-Revised (min: 0, max: 320, the highest score corresponds to the highest level of symptoms severity)	change from baseline to 6-month follow up
Secondary	Harmony	Visual analouge scale (min: 0, max: 100, the highest score corresponds to the highest level of harmony)	change from baseline to 6-month follow up