Positive Psychological Interventions for Patients With Multiple Sclerosis

NCT ID: NCT06500039

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-01-01

Brief Summary

This study aims to determine the effectiveness of positive psychological interventions on the quality of life and well-being levels of patients with multiple sclerosis.Two groups will be selected as intervention and control groups. An intervention method consisting of three good things in life and gratitude activities, each lasting two weeks, was determined for the intervention group. An activity was planned for control group participants to write their daily routines.

Detailed Description

People with Multiple Sclerosis (MS) face numerous physical and mental symptoms as well as emotional and social challenges. The fact that the disease usually occurs in young adulthood, when individuals are most productive, causes disability, its unpredictable and variable nature, and the lack of a known treatment make it difficult to live with MS and accept the disease. The physical, cognitive, behavioral and social changes that occur with the disease affect daily life activities, well-being. and greatly affects the quality of life. There are various interventions developed to improve the adaptation processes of individuals diagnosed with a chronic disease such as MS, to prevent and reduce psychiatric symptoms, and to increase quality of life and well-being. One of the intervention approaches is positive psychological interventions from the field of positive psychology. Positive psychological interventions are a psychosocial intervention method based on the systematic completion of certain activities aimed at increasing positive emotions, thoughts and behaviors. Since the interventions focus on strengthening positive mental states rather than reducing psychological symptoms, they also have an advantage over traditional interventions in that they can be applied to both sick and non-patients. However, it appears that positive psychological intervention studies have just begun to be implemented in patients with MS. In our country, no study has been found using positive psychological intervention in MS patients. This study aims to determine the effectiveness of positive psychological interventions on the quality of life and well-being levels of patients with multiple sclerosis.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Participants will implement positive psychological interventions at home for four weeks. In the first two weeks, they will do the three good things in life exercise, in the third week, they will write a gratitude letter, and in the fourth week, they will write five things they are grateful for. Participants will be given a guide booklet to write on.

Group Type: ACTIVE_COMPARATOR

Positive Psychological Intervention Program

Intervention Type: OTHER

An intervention method consisting of three good things in life and gratitude activities was determined for the intervention group. It will take four weeks. Three good deeds will be held for two weeks, and gratitude activities will be held for the last two weeks. Participants will record the interventions on a prepared booklet.

Kontrol group

Control group participants will practice writing their daily routines for four weeks. They will write a few sentences about the nutrition routine in the first week, the hygiene routine in the second week, the sleeping routine in the third week, and the shopping routine in the fourth week. Participants will be given a guide booklet for the writing exercise.

Group Type: PLACEBO_COMPARATOR

Writing Daily Routines

Intervention Type: OTHER

An activity was planned for the control group participants to write their daily routines. They will write down their sleep, nutrition, hygiene and shopping routines, which will be different each week for four weeks. Control group participants will also be given a booklet to write on.

Interventions

Positive Psychological Intervention Program

An intervention method consisting of three good things in life and gratitude activities was determined for the intervention group. It will take four weeks. Three good deeds will be held for two weeks, and gratitude activities will be held for the last two weeks. Participants will record the interventions on a prepared booklet.

Intervention Type: OTHER

Writing Daily Routines

An activity was planned for the control group participants to write their daily routines. They will write down their sleep, nutrition, hygiene and shopping routines, which will be different each week for four weeks. Control group participants will also be given a booklet to write on.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of MS by a neurologist according to McDonald criteria
• Having at least 1 year of MS history
• Expanded Disability Status Scale (EDSS) score measured by the neurology clinic is <3.5
• Being between the ages of 18-65 being literate
• Ability to communicate in Turkish
• Volunteering to participate in the study

Exclusion Criteria

• Having an MS attack and using corticosteroid medication for the last 3 months
• A score of 21 or less on the Montreal Cognitive Assessment (MoCA) test
• Having a mental or organic disability in communicating
• Being diagnosed with any chronic disease other than MS
• Using psychotropic medication or continuing psychotherapy
• Not having or being able to obtain a phone that can connect to the internet

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Aliye Yaşayacak

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nazmiye Yıldırım

Role: STUDY_CHAIR

Bolu Abant İzzet Baysal University

Aliye Yaşayacak

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant İzzet Baysal University

Locations

Bolu Abant İzzet Baysal University

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AbantIBU-SBF-AY-01

Identifier Type: -

Identifier Source: org_study_id