Positive Psychological Interventions for Patients With Multiple Sclerosis

NCT06500039 | Enrolling By Invitation

• 1 other identifier: AbantIBU-SBF-AY-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Quality of Life, Well-Being

Outcome Measures

Primary Outcomes (2)

• Multiple Sclerosis Quality of Life Scale (MSQOL)-54

  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.

  six month

• PERMA Measuring Tool

  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.

  six month

Secondary Outcomes (1)

• Positive and Negative Mood Scale (PNDS)

  six month

Study Arms (2)

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.

Other: Positive Psychological Intervention Program

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.

Other: Writing Daily Routines

Interventions

Positive Psychological Intervention Program 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.

Intervention group

Writing Daily Routines 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.

Kontrol group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, 14300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nazmiye Yıldırım

  Bolu Abant İzzet Baysal University

  STUDY CHAIR

• Aliye Yaşayacak

  Bolu Abant İzzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The research was planned as a randomized controlled prospective study. It will be carried out in two groups.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: July 15, 2024
• Primary Completion: August 30, 2024
• Study Completion: January 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)