Stress, Scleroderma and Quality of Life

NCT05617066 | Completed

• 1 other identifier: AEE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

scleroderma, stress, cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Cortisol y psychological stress levels

  Decreased cortisol and psychological stress after therapy

  3 months

Secondary Outcomes (1)

• Quality of life and psychological status

  3 months

Study Arms (2)

therapy vs psychological support and usual care

ACTIVE COMPARATOR

Comparison between therapy groups vs psychological support and usual care. Only one group receive therapy.

Behavioral: Cognitive behavioral therapy

therapy and psychological support versus control group

NO INTERVENTION

Comparison between therapy groups vs psychological support and usual care. Only one group receive therapy.

Interventions

Cognitive behavioral therapy BEHAVIORAL

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

therapy vs psychological support and usual care

Eligibility Criteria

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

You may qualify if:

• Diagnosis made by a specialist doctor, good command of the Spanish language (oral and written comprehension) and have an internet connection.

You may not qualify if:

• No psychiatric illness.

Sponsors & Collaborators

• Asociación Española de Esclerodermia: lead

Study Sites (1)

Universidad de Granada

Granada, 18070, Spain

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. PhD in Psychology. Clinic Psychologist

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 15, 2022
• Study Start: November 26, 2022
• Primary Completion: March 31, 2023
• Study Completion: September 1, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)