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Completed

NCT Number: NCT04212247

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fiammetta Cosci, Florence, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • currently under psychotherapy;
  • change of the pharmacological treatment (including psychotropic medications) during the last three months.
  • any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.

Treatment and study plan

Well-Being Therapy

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

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.

Primary outcomes

  1. Disability due to systemic sclerosis

    Time frame: 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 outcomes

  1. Psychiatric status

    Time frame: change from baseline to 6-month follow up

    Psychiatric status assessed via the Mini-International Neuropsychiatric Interview (no score applicable)

  2. Psychosomatic status

    Time frame: change from baseline to 6-month follow up

    Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (no score applicable)

  3. Well-being

    Time frame: 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)

  4. Psychological well-being

    Time frame: 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)

  5. Euthymia

    Time frame: change from baseline to 6-month follow up

    Euthymia Scale (min: 0, max: 60, the highest score corresponds to highest level of euthymia)

  6. Suffering

    Time frame: 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)

  7. Psychological distress

    Time frame: 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)

  8. Pain in the body

    Time frame: change from baseline to 6-month follow up

    Brief Pain Inventory (min: 0, max: 70, the highest score corresponds to highest level of pain)

  9. Mental pain

    Time frame: 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)

  10. Psychiatric symptoms

    Time frame: 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)

  11. Harmony

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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