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

NCT ID: NCT04212247

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-10-31

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.

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Well-Being Therapy

Intervention Type: BEHAVIORAL

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 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.

Group Type: PLACEBO_COMPARATOR

Control condition

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Fiammetta Cosci

Associate Professor in Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rheumtoi Unit, Academic Hospital Careggi

Florence, , Italy

Fiammetta Cosci

Florence, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 38366929 (View on PubMed)

Other Identifiers

WBT in SSc

Identifier Type: -

Identifier Source: org_study_id