Trial on Outpatients With Systemic Sclerosis Treated With Well-Being Therapy or With a Control Therapy
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

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.
    

Intervention name(s): Well-Being Therapy; Control condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: systemic sclerosis, well-being, psychological distress, suffering, mental pain, well-being therapy, psychotherapy