MedTrace Logo

Effectiveness of a Psychoeducational Intervention on Myositis Patients' Quality of Life and Well-Being

NCT06300983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-03-08

No results posted yet for this study

Summary

Purpose. Myositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented.

Materials and Methods. All myositis patients in a health district are contacted. Eligible patients are randomly assigned to the experimental or control group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life is conducted only in experimental patients. Several reliable tools to measure quality of life and well-being are administered twice, before and after the intervention, to both groups.

Conditions

  • Quality of Life
  • Myositis

Interventions

BEHAVIORAL

Psychoeducative

The intervention consiste of 5 sessions (Table 1), with each lasting 100 minutes and delivered on a weekly basis. Individual meetings will be conducted with each participant prior to starting the group work. These were considered pre-intervention sessions, during which patients provided informed consent to participate in the study and the first assessment tests were administered.

BEHAVIORAL

Placebo

The control group, which do not receive any psychoeducative intervention

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Albert S Selva-O'Callaghan, Prof · Vall d'Hebron General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2022-10-31
Completion
2022-10-31

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 NCT06300983 on ClinicalTrials.gov