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

November 28, 2023 updated by: Fiammetta Cosci, University of Florence

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Florence, Italy, 50135
        • Rheumtoi Unit, Academic Hospital Careggi
      • Florence, Italy
        • Fiammetta COSCI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
change from baseline to 6-month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychiatric status
Time Frame: change from baseline to 6-month follow up
Psychiatric status assessed via the Mini-International Neuropsychiatric Interview (no score applicable)
change from baseline to 6-month follow up
Psychosomatic status
Time Frame: change from baseline to 6-month follow up
Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (no score applicable)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up
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)
change from baseline to 6-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WBT in SSc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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