NCT06248281

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

Be Cool: An Innovative and Holistic Psychoeducational Program to Improve and Promote Care, Education and Quality of Life for Multiple Sclerosis Individuals

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University of Thessaly · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fifteen individuals with multiple sclerosis will participate in an innovative, hybrid rehabilitation program, encompassing several key components to enhance their well-being. The program includes: 1. Exercise Intervention: Participants will engage in specially designed exercise programs. Every two weeks, they will meet virtually with an exercise physiologist via Microsoft Teams for tailored education about their specific needs. Additionally, a customized exercise video will be uploaded weekly to the Teams platform, ensuring ongoing physical engagement. 2. Nutritional Evaluation and Education: Nutrition is a core focus. A nutritionist will meet with the participants bi-weekly to discuss their dietary needs and educate them on maintaining a balanced diet to support their condition. Further enhancing this aspect, a nutritious recipe will be uploaded to the platform each week, offering practical dietary guidance. 3. Psychological Support: Psychological well-being is addressed through weekly group meetings conducted by a psychologist. These sessions will utilize Acceptance and Commitment Therapy (ACT) strategies to help participants manage their symptoms, accept their condition, and improve their overall quality of life. 4. Head and Neck Cooling Strategy: Recognizing the importance of temperature regulation in MS, participants will be advised to apply a cooling strategy to the head and neck area for at least two hours daily, providing symptomatic relief. To monitor progress and adjust the program as needed, participants' functional ability, nutritional status, psychological condition, and overall quality of life will be evaluated at three key points: baseline (before starting the program), at the three-month mark, and upon completion of the program at six months. This program is structured to provide a holistic, supportive, and adaptable approach to managing multiple sclerosis, focusing on physical health, nutritional balance, psychological support, and practical strategies for daily living.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-07-01
• Completion: 2024-02-28
• First posted: 2024-02-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: Greece