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

NCT04212247 | Completed

• 1 other identifier: WBT in SSc
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Systemic Sclerosis

Keywords

systemic sclerosis, well-being, psychological distress, suffering, mental pain, well-being therapy, psychotherapy

Outcome Measures

Primary Outcomes (1)

• Disability due to systemic sclerosis

  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).

  change from baseline to 6-month follow up

Secondary Outcomes (11)

• Psychiatric status

  change from baseline to 6-month follow up

• Psychosomatic status

  change from baseline to 6-month follow up

• Well-being

  change from baseline to 6-month follow up

• Psychological well-being

  change from baseline to 6-month follow up

• Euthymia

  change from baseline to 6-month follow up

Study Arms (2)

Well-being therapy

EXPERIMENTAL

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.

Behavioral: Well-Being Therapy

Control condition

PLACEBO COMPARATOR

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.

Behavioral: Control condition

Interventions

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.

Well-being therapy

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.

Control condition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florence: lead

Study Sites (2)

Rheumtoi Unit, Academic Hospital Careggi

Florence, 50135, Italy

Location

Fiammetta Cosci

Florence, Italy

Location

Related Publications (1)

• 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.

  PMID: 38366929 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed if they will receive WBT or the control condition. At the end of the study they will receive this information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Clinical Psychology

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 26, 2019
• Study Start: June 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)