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Clinical Trials/NCT06500039
NCT06500039Enrolling By InvitationNot Applicable

The Effect of Positive Psychological Interventions on Quality of Life and Well-Being in Patients With Multiple Sclerosis

Abant Izzet Baysal University1 site in 1 country30 target enrollmentStarted: July 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
30
Locations
1
Primary Endpoint
PERMA Measuring Tool

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention group

Active Comparator

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.

Intervention: Positive Psychological Intervention Program (Other)

Kontrol group

Placebo Comparator

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.

Intervention: Writing Daily Routines (Other)

Outcomes

Primary Outcomes

PERMA Measuring Tool

Time Frame: six month

It was developed by Butler and Kern (2016) to measure well-being levels. The scale consists of a total of 23 items, 15 items measuring the components of the well-being model and 8 filler items. Among the filler items in the scale, items 7, 12, 14 and 20 are reverse coded. There are 3 items in each dimension of the scale, which consists of 15 items. Sub-dimension scores are calculated by taking the average of the 3 items in the relevant sub-dimension. The Cronbach Alpha internal consistency coefficient for the total score of the scale is 91.

Multiple Sclerosis Quality of Life Scale (MSQOL)-54

Time Frame: six month

It was developed by Vickrey, Hays, Harooni, Myers, and Ellison (1995). The scale consists of 2 main groups, composite physical health (BFS) and composite mental health (BMS), 12 subgroups and 2 independent items. The reliability coefficients of the scale were found to be between 0.75-0.96, and the test-retest reliability coefficients were found to be between 0.66-0.96. BFS and BMS scores, the two main groups of the MSQOL-54 scale, take a value between 0-100. A high score from the scale indicates a high quality of life.

Secondary Outcomes

  • Positive and Negative Mood Scale (PNDS)(six month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aliye Yaşayacak

Lecturer

Abant Izzet Baysal University

Study Sites (1)

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