NCT05840653

Brief Summary

Multiple Sclerosis (MS), causing damage to myelin sheath and axons; It is a chronic disease with diffuse demyelinating lesion of the Central Nervous System (CNS) that often affects young adults, progresses with attacks and remissions, and may bring about functional limitation, disability or decrease in quality of life. The fact that Multiple Sclerosis is chronic and irreversible, the uncertainty and destructiveness of the disease process affect individuals physically over time, but it can also cause many negative symptoms from a mental perspective. Studies have shown that MS disease; anxiety, depression, loss of life purpose, intense hopelessness and suicide. Life purpose has been defined as struggling to achieve one's goals and creating meaning against existential neurosis. Having a life purpose increases the subjective well-being, life satisfaction and hope level of individuals. According to the Turkish Language Association, hope, which is defined as "the feeling of trust arising from hope" and which indicates the feeling of having positive expectations for the future, positively affects mental health by giving people the feeling that they can cope with negative experiences that they may encounter in the future. Hopelessness, which is the opposite of hope, is a feeling that causes mental problems such as depression and suicide as well as negatively affecting the mental health of the individual and is a part of these clinical pictures. Setting a life purpose has positive effects on hope. While a purposeful life increases the level of hope in people, it reduces hopelessness and causes the person to live a more meaningful life. The decrease or loss of hope and the purpose of life can cause significant problems for people such as depression, addiction or suicide may occur in people who have lost their life purpose and hope. Positive psychotherapy (PPT), one of the psychosocial-based intervention methods, is a therapy method with a humanistic approach, the theoretical foundations of which were established by Pesesschkian in 1970. There are three basic principles of therapy: hope, balance and consultation. In Positive Psychotherapy, the symptoms and ailments in the person; It is positively reinterpreted, emphasizing real talents. Sharing the function of the existing symptom with the client increases the client's acceptance and hope for himself and his situation, which in turn activates the hope principle.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

November 20, 2021

Last Update Submit

April 24, 2023

Conditions

Keywords

multiple sclerosishopelife purposePsychiatric Nursingpositive psychotherapy

Outcome Measures

Primary Outcomes (3)

  • experiment 1 and experiment 2 group level of determination of life purpose

    In the experimental 1 and 2 groups, it is expected that there will be a significant increase in the total score of the life goals determination scale compared to the first test.

    5 weeks

  • experiment 1 and experiment 2 group hopelessness is to decrease.

    It is expected that there will be a significant decrease in the beck hopelessness scale total score in the experimental 1 and 2 groups compared to the first test.

    5 weeks

  • control1 and control 2 group hopelessness is to decrease.

    No change in life purpose and hopelessness level in Experiment 2 and Experiment 2 groups

    5 weeks

Study Arms (4)

experimental 1: Intervention group

EXPERIMENTAL

Experiment 1 group will first be given a pre-test, then a 5-week hope placement program will be applied. The final test will be administered after the program is completed.

Other: psychotherapeutic intervention

experimental 2 group; Intervention group

EXPERIMENTAL

A 5-week hope placement program will be applied to the experimental 2 group without the pre-test application. After the program is completed, the final test will be administered.

Other: psychotherapeutic intervention

control 1 group; not Intervention group

NO INTERVENTION

only the pre-test will be applied, other than that, no intervention will be applied in the 5-week period. Then the final test will be applied.

control 2 group; not Intervention group

NO INTERVENTION

No intervention will be applied during the pre-test application and the 5-week period. then the final test will be administered.

Interventions

The group that will receive 5-week positive psychotherapy-based hope placement psychoeducation

experimental 1: Intervention groupexperimental 2 group; Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with MS for at least 6 months,
  • Not having a chronic disease diagnosis other than Multiple Sclerosis,
  • Not having any diagnosed psychotic illness,
  • Ability to read and write
  • Being between the ages of 18-65,
  • Not having a verbal or hearing disability that may affect communication,
  • Owning a smart phone or computer,
  • Ability to use the Internet, participate in online programs,
  • Regular follow-up of psychoeducations,
  • Participating in and completing all psychoeducational trainings,
  • Filling the pretest and posttest questionnaires,
  • Volunteering to participate in the study.

You may not qualify if:

  • Having a chronic disease other than Multiple Sclerosis,
  • Not having any diagnosed psychotic illness,
  • Having a verbal or hearing disability that may affect communication,
  • Not having a smart phone or computer,
  • Not having the ability to use the Internet or participate in online programs,
  • Having an EDSS score of 6.5 and above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAMSUN

Samsun, 55000, Turkey (Türkiye)

Location

Related Publications (1)

  • Cope, T. (2010). The inherently integrative approach of Positive psychotherapy. The Journal of Psychotherapy Integration 20(2), 203-250.

    BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • kübra gülırmak, MSc

    ONDOKUZ MAYIS UNİVERSITY

    STUDY DIRECTOR
  • kübra gülırmak, msc

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra GÜLIRMAK, MSc

CONTACT

Serap GÜLEÇ KESKİN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This research is planned to be carried out as a Solomon Four-Group Experimental model. In the Solomon 2x2 designs, two of the four groups consisting of randomly assigned members by randomization constitute the experimental group and the other two constitute the control group. In the Solomon model, for statistical operations, pretesting is performed on two groups, one for the experimental group and the other for the control group, while the posttest process is performed on all four groups (Erkuş, 2011). The Solomon model is formed by using the pretest-posttest control group model and the posttest control group model together. In this way, the Solomon four-group experimental model is the strongest experimental model that preserves both internal and external validity (Karasar, 2011).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant in psychiatric nursing department

Study Record Dates

First Submitted

November 20, 2021

First Posted

May 3, 2023

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations