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

Not Applicable

Completed

• Conditions: Systemic Sclerosis
• Interventions: Behavioral: Well-Being Therapy; Behavioral: Control condition

• Registration Number: NCT04212247
• Lead Sponsor: University of Florence

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.

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-26
• Study Start: 2020-06-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Well-being therapy	Well-Being Therapy	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.
Control condition	Control condition	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.

Primary Outcome Measures

Name	Time	Method
Disability due to systemic sclerosis	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).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Rheumtoi Unit, Academic Hospital Careggi; 🇮🇹 Florence, Italy

Fiammetta Cosci; 🇮🇹 Florence, Italy