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Be Cool: An Innovative and Holistic Psychoeducational Program for Multiple Sclerosis Individuals

NCT06248281 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-05-08

No results posted yet for this study

Summary

This observational study aims to investigate the impact of an online psychoeducational program, combined with cooling therapy, nutrition, psychological intervention, and exercise, on the resilience, treatment adherence, symptom management, and quality of life of individuals with Multiple Sclerosis. The study will last for six months, during which two groups of 15 participants with similar characteristics and a diagnosis of Multiple Sclerosis will take part in the protocol. Group A will follow the research protocol, while Group B, the Control group, will not participate in any rehabilitation intervention.

Conditions

Interventions

OTHER

combination of different rehabilitation strategies

The psychoeducational program will be conducted through weekly online video-conferencing group sessions that will last for two hours. In addition to these sessions, participants will receive psychoeducational material such as readings, videos, podcasts, worksheets, and homework exercises every week. This material will allow participants to practice at their own pace during the session intervals. The exercise training program for individuals with MS will be tailored to meet the unique and individual needs of each participant. To achieve this, a head and neck cooling protocol will be implemented using commercially available cooling equipment, specifically the Headcool Power and Neckcool Tie from Inuteq. Participants will need to wear the cooling cup and neck wrap for two hours daily. The equipment will be activated using 10°C tap water. Finally, a nutritionist will provide personalized nutritional guidance including weekly diet observation and recipe videos.

Sponsors & Collaborators

  • Greek Multiple Sclerosis Society

    collaborator UNKNOWN

  • European Committee for Treatment and Research in Multiple Sclerosis

    collaborator UNKNOWN

  • University of Thessaly

    lead OTHER

Principal Investigators

  • Anastasios Orologas, MD, PhD · Greek Multiple Sclerosis Society

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-07-01
Completion
2024-02-28

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

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 NCT06248281 on ClinicalTrials.gov