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

NCT06248281 | Completed

• 1 other identifier: 396/23
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

symptom management; hybrid program; rehabilitation; quality of life; psychoeducational program

Outcome Measures

Primary Outcomes (11)

• anxiety and depression

  This will be estimated with the "The Hospital Anxiety and Depression Scale - HADS". The Hospital Anxiety and Depression Scale (HADS) is a widely used questionnaire specifically designed to identify and measure the levels of anxiety and depression in individuals. It is particularly useful in medical settings, as it helps distinguish between psychological distress and physical illness.

  Baseline, after three months and at the end of the six months

• Overall quality of life, namely satisfaction with their life

  This will be estimated with the questionnaire of Multiple Sclerosis Quality of Life-54 (MSQOL-54)

  Baseline, after three months and at the end of the six months

• Perception of stress

  Perceived Stress Scale (PSS) will be used. This is a widely used psychological instrument for measuring the perception of stress. It assesses the degree to which situations in one's life are appraised as stressful. Items on the PSS ask about feelings and thoughts during the last month, and scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress.

  Baseline, after three months and at the end of the six months

• Cognitive fusion which refers to the degree to which an individual's thoughts and feelings are intertwined with their sense of self, often leading to an inability to separate from, or 'defuse' from, these internal experiences.

  The Cognitive Fusion Questionnaire (CFQ-7) questionnaire that measures cognitive fusion, which a key concept in Acceptance and Commitment Therapy (ACT) will be used. The CFQ-7, with its 7 items, assesses the extent to which a person experiences this phenomenon.

  Baseline, after three months and at the end of the six months

• The value of living

  The Valued Living Questionnaire (VLQ) will be used. The VLQ is designed to assess valued living, which is another core concept in ACT. It helps individuals to identify what is truly important and meaningful to them in various domains of life (such as family, career, health) and to what extent they have been living in accordance with these values.

  Baseline, after three months and at the end of the six months

• Psychological flexibility which is the ability to be in the present moment with full awareness and openness to experiences, and to take action guided by one's values.

  The MPFI-Psychological Flexibility Subscale will be used. This subscale is part of a larger questionnaire and specifically measures psychological flexibility, an essential aspect of mental health and well-being.

  Baseline, after three months and at the end of the six months

• The resilience which is defined as the ability to cope with and bounce back from adversity.

  The Connor-Davidson Resilience Scale (CDRISC-25) will be used. This 25-item scale measures resilience, defined as the ability to cope with and bounce back from adversity. Higher scores indicate greater resilience.

  Baseline, after three months and at the end of the six months

• Aerobic capacity and ability to walk

  The Two Minute Walk Test (2MWT) is a simple, easy-to-administer functional exercise test used primarily in clinical settings. It measures the distance an individual is able to walk on a flat, hard surface in a period of two minutes.

  Baseline, after three months and at the end of the six months

• Lower body strength and functional mobility

  The Five Times Sit to Stand Test (5xSST) will be used which is a simple yet effective physical performance test used primarily to assess lower body strength and functional mobility. The test involves timing how long it takes an individual to stand up and sit down five times as quickly as possible from a standard height chair without using their arms for support. A longer time to complete the test generally indicates lower functional performance.

  Baseline, after three months and at the end of the six months

• Static and dynamic balance ability

  The Berg Balance Scale (BBS) will be used which is a widely used clinical test of a person's static and dynamic balance abilities. It is particularly common in elderly populations and among those recovering from injury or dealing with conditions that affect balance.

  Baseline, after three months and at the end of the six months

• Mobility and walking speed

  The Timed 25-Foot Walk (T25-FW) will be used which is a functional test commonly used to assess mobility and walking speed in individuals, particularly those with neurological conditions such as multiple sclerosis (MS).The test involves timing how quickly a person can walk 25 feet at their usual pace, usually conducted along a flat, straight course.

  Baseline, after three months and at the end of the six months

Secondary Outcomes (4)

• Finger dexterity and arm-hand coordination

  Baseline, after three months and at the end of the six months

• Core temperature

  Baseline, after three months and at the end of the six months

• Skin temperature

  Baseline, after three months and at the end of the six months

• Nutritional status, how balance is their nutrition

  Baseline, after three months and at the end of the six months

Study Arms (2)

Experimental group

The experimental group will attend a structured psychoeducational program developed to build and promote psychological flexibility. In combination with this, participants of this group will have to follow a head and neck cooling protocol. Also, participants of this group will be required to increase their habitual exercise levels and follow a video exercise program specifically designed for their needs and improve their nutrition based on the instructions of a nutritionist and videos specially designed for them.

Other: combination of different rehabilitation strategies

Control group

As per the study plan, the Control group has been designated as the control group. They will continue with their normal lifestyle without any participation in rehabilitation activities or programs.

Other: combination of different rehabilitation strategies

Interventions

combination of different rehabilitation strategies OTHER

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.

Also known as: cooling therapy, diet, phycology-behavioral-mindfulness intervention, exercise traiining

Control group; Experimental group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the GMSS (https://gmss.gr/) based on specific inclusion and exclusion criteria.

You may qualify if:

• Participants must have been diagnosed with MS using the McDonald criteria, ensuring a standardized and validated diagnostic approach.
• Participants should have been relapse-free during the six months leading up to the study to avoid potential confounding factors.
• Participants must have no musculoskeletal impediment that could affect their ability to engage in the exercise component of the program.
• Participants must have a score on the Expanded Disability Status Scale (EDSS) ranging from 0 to 5.5, indicating ambulatory ability without the need for a cane for at least 100 meters.
• Participants should have a history of sensitivity to heat, as reported by their treating physician, justifying the need for cooling therapy as part of the hybrid program.
• Participants must not have used cooling therapy or participated in any form of exercise training for at least four months prior to their participation in the study.

You may not qualify if:

• Previously diagnosed conditions known to impact physiological responses to heat exposure, including diabetes mellitus, hypertension, heart disease, or kidney disease.
• Use of medications to manage MS-related symptoms, such as antidepressants, psychostimulants, anticonvulsants, antispasmodics, and anticholinergic drugs.

Sponsors & Collaborators

• University of Thessaly: lead
• Greek Multiple Sclerosis Society: collaborator
• European Committee for Treatment and Research in Multiple Sclerosis: collaborator

Study Sites (1)

Greek Multiple Sclerosis Society

Thessaloniki, Central Macedonia, 55132, Greece

Location

Related Publications (1)

• Kaltsatou A, Flouris AD. Impact of pre-cooling therapy on the physical performance and functional capacity of multiple sclerosis patients: A systematic review. Mult Scler Relat Disord. 2019 Jan;27:419-423. doi: 10.1016/j.msard.2018.11.013. Epub 2018 Nov 13.

  PMID: 30544086 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cryotherapy; Diet

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anastasios Orologas, MD, PhD

  Greek Multiple Sclerosis Society

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Lecturer

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: February 8, 2024
• Study Start: June 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: February 28, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)