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

NCT04212247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-29

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04212247 on ClinicalTrials.gov