MedTrace Logo

Stress, Scleroderma and Quality of Life

NCT05617066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-02-01

No results posted yet for this study

Summary

150 patients of legal age will participate in this project, diagnosed with systemic sclerosis.

Patients will be randomly assigned, as will be detailed later, to one of the following three groups:

Therapy Group (GT): This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress (online modality) in groups of 10-12 people during twelve sessions Consecutive weekly courses of 1.5 to 2 hours duration taught by psychology professionals. of this mode 4 subgroups will be made. Psychological Support Group (AP): This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma. It will have a duration of twelve weekly sessions.

Consecutive sessions of 1.5 to 2 hours in length taught by professional psychologists. In this way they will 4 subgroups. Usual Care Group (CG): This group will be made up of 50 patients who will follow their usual care. Later, once the study is over, they will be offered to participate in coping with stress to the person who is interested.

Conditions

  • Scleroderma

Interventions

BEHAVIORAL

Cognitive behavioral therapy

With the cognitive behavioral therapy will work on different aspects for coping and tools psychological stress.

Sponsors & Collaborators

  • Asociación Española de Esclerodermia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-26
Primary Completion
2023-03-31
Completion
2023-09-01

Countries

  • Spain

Study Locations

More Related Trials

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 NCT05617066 on ClinicalTrials.gov